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Laurence Auffret (Click name for full details)
Company: CINETIQUE Translations
Qualifications: MSc Bioeng, MA Ling, MCIL
Laurence founded CINETIQUE Translations (ISO 9001:2008) in 2003 after working as a scientist in France and a language lecturer in UK universities (Translation, Computer-assisted learning, Erasmus International programmes). CINETIQUE Translations specialises in language services (translation, interpreting and writing) for life science, technology and engineering with a strong focus on clinical trials documentation. Laurence and her team currently manage large translation projects for European and US-based clients. In May 2009, Laurence also became part of EMWA’s Executive Committee and was President of EMWA from May 2010 to May 2011.
Clare Baker (Click name for full details)
Company: Biogen International
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Clare has more than 12 years’ experience in the Medical Communications industry, across both agency and pharmaceutical companies. Clare began her scientific career as a pharmacologist, and worked in cancer research for several years, before embarking on a career in medical writing. During her time working for medical communications agencies in Macclesfield, UK, Clare led scientific writing teams to deliver medical communications and publications programmes for several large pharmaceutical clients across a broad range of products. Clare is now based in Switzerland and currently leads Scientific Communications for the Biosimilars team at Biogen International.
Helen Baldwin (Click name for full details)
Company: Scinopsis
Qualifications: PhD
Helen is the founder and Managing Director of Scinopsis, a medical writing consultancy based in France and the UK. She has worked in the field of medical writing since 1999 and is experienced in regulatory writing and medical communications. She previously held the posts of EMWA Vice President and President.Helen enjoys training and mentoring new medical writers. She is also fully aware of the stresses and challenges faced by people working in our industry. She has a holistic approach to life and uses mindfulness to help her cope with these challenges.
Slavka Baronikova (Click name for full details)
Company: baroniCo BVBA
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Slavka is a clinical pharmacist with academic scientific and educational experience. After moving to pharmaceutical industry and clinical research almost 15 years ago, she followed her passion - scientific disclosure and ethics. She joined the team of publications leads in GSK Vaccines and later in Shire where she leads publication & scientific disclosure teams in different therapeutic areas and at all stages of drug development. Slavka has been an accredited member of EMWA since 2011, EMWA Conference Director since 2014 and a certified ISMPP medical publication professional (CMPP) since 2012.
Susan Bhatti (Click name for full details)
Company: Merck KGaA
Qualifications: PhD
Susan has spent over 20 years working in regulatory affairs in both the pharmaceutical industry and the CRO industry. She can therefore share many years of experience of interacting with European regulatory authorities and is an expert in European regulatory requirements. She has been responsible for the submission of clinical trial applications and marketing authorisation applications in many countries in Europe as well as participating in scientific advice meetings with the EMA and national regulatory authorities. Over the years she has had first-hand experience of the increasing complexity of the regulatory environment that has accompanied the growth of the European Union. Susan was elected Vice President of EMWA in May 2011 and served as President from May 2012 to May 2013.
Katharina Biester (Click name for full details)
Company: IQWIG
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Katharina initially trained and worked as a paediatric nurse and then studied Health Care Management. In 2004 she started working as a research associate in the Department of Non-Drug Interventions at the Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany. In 2010 she transferred to the Drug Assessment Department. At IQWiG she discovered her interest in medical writing for health technology assessment topics. Her main responsibilities are the assessment of drugs and the writing of the corresponding IQWiG reports, as well as the quality assurance of such reports.
Raquel Billiones (Click name for full details)
Company: Clinipace Worldwide
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Raquel has a PhD in Biology and more than 25 years combined experience in scientific and clinical research. She has been a medical writer for more than 13 years, with core competencies in writing clinical trial and regulatory documents for pharmaceuticals and medical devices. Her medical device experience includes writing clinical investigation plans and reports and clinical evaluation plans and reports for CE Class II and Class III medical devices. Her experience also includes transparency, disclosure and patient data protection in clinical trial data reporting. Her current position is [TBD]. Previously, she worked for a mid-sized global CRO where she established and led a small team of writers and support staff located in the US, Europe, and Asia. Raquel is an active member of EMWA, serving in various roles, including as Executive Committee member (2015-2017), associate editor of MEW (2010-present), internship advocate, workshop leader, and co-chair of the Medical Device Special Interest Group (MD SIG).
Rosemary Bischoff (Click name for full details)
Company: ClinWrite
Qualifications: MS
Rosie has been in the pharmaceutical industry since 1974; most of that time as a clinical project leader for a pharmaceutical company in Berlin where she was responsible for the design, conduct and reporting of numerous studies. However, she began her career there writing manuscripts for publication in English and German and ended it as head of clinical operations for the business unit Therapeutics. In 1998 she started her own medical writing business, ClinWrite. She also served on the EMWA Professional Development Committee (EPDC) for many years.
Graham Blakey (Click name for full details)
Company: consult2deliver limited
Qualifications: MSc, PhD, MRPharmS
Graham is part owner of consult2deliver limited, a company based at BioCity in Nottingham.  Graham has used his specialist knowledge of clinical pharmacology and pharmacokinetics to provide solutions that have helped to progress new chemical entities from pre-clinical through to patient confirmatory trials.  He is an advocate of creative and efficient clinical study design and has applied these principles across a range of global drug development projects in several therapeutic areas including inflammation, cardiovascular, oncology and neurology. In his current role he has provided support to large pharma and smaller biotech companies.  This has involved PK/PD modelling support, project management of the clinical pharmacology components for novel drugs and support to regulatory submissions and Scientific Advice Meetings.  Graham has written and delivered several bespoke training courses covering pharmacokinetics and pharmacodynamics.  At AstraZeneca he was a principal scientist, and developed strategic thinking on drug-drug interactions within the clinical function.
Oleg Borisenko (Click name for full details)
Company: European Med Tech Reimbursement Consulting AB
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Oleg Borisenko (MD, PhD) is the Founder and CEO of the Stockholm-based Med Tech consulting company European Med Tech Reimbursement Consulting AB. He has 11 years of experience in the field of market access for medical devices and in-vitro diagnostic tests. Previous positions include Senior Health Economist and Director of Market Access and Health Economics at the consulting company Synergus. During the course of his professional career, Oleg has supervised several hundreds of projects, including reimbursement mappings and strategies, value dossiers, systematic literature reviews, health economic models, and within-trial economic evaluations.
Katharina Brauburger (Click name for full details)
Company: Sandoz, a Novartis division
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Katharina is a biologist by training. She received a doctoral degree working on protein biochemistry and molecular tumour biology. Afterwards she decided to become a Medical Writer and joined Boehringer Ingelheim to start her regulatory medical writing career. In 2015, Katharina joined the Clinical Submission Management team of Sandoz, a Novartis division and continued working as a regulatory Medical Writer, mainly writing biosimilar submission documents. Katharina has been involved in document writing across various stages of clinical development and across various indications.
Helen Bridge (Click name for full details)
Company: AstraZeneca
Qualifications: DPhil
Helen is a biologist and linguist who has always enjoyed both writing and interpreting data. After leaving her previous career as a university teacher and researcher in German literature, she completed a degree in life sciences with statistics, and became a medical writer in 2012. She worked in a CRO for 6 years before moving to AstraZeneca in March 2018. She has written a wide range of regulatory documents, with a particular focus on CTD clinical summaries and overviews, study reports, and protocols.
Danny Buckland (Click name for full details)
Company:
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Danny Buckland is an award-winning health journalist working for national newspapers, magazines and online sites in the UK and Europe. He has held several executive positions on newspapers and is now a respected freelance writer with special interest in medical technology and mental health. He has covered international conflicts, domestic news and interviewed senior political and entertainment figures in a career spanning 25 years. He regularly produces engaging features and is also commissioned to write insight pieces for major publications. Danny is part of the award-winning Sunday Express Crusade for Better Mental Health, which has been campaigning and raising awareness for five years.
Pia Caduff-Janosa (Click name for full details)
Company: Uppsala Monitoring Centre
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Pia Caduff-Janosa is a graduate from Medical School of the University of Basel (Switzerland), has completed her doctorate at the University of Bern (Switzerland) and holds a Diploma in Pharmacovigilance from the University of Hertfordshire (UK). After her postgraduate training in internal medicine, surgery and anaesthesia in Switzerland and New Zealand, she qualified as a specialist in anaesthesiology and spent many years in clinical practice. She joined the Swiss Regulatory Authority Swissmedic (former IKS) in 1999 as a clinical reviewer and headed the Unit Vigilance from 2009 to 2012. Key responsibilities in these positions included the assessment and communication of safety issues related to medicines and their use. In January 2013 she joined the Uppsala Monitoring Centre as Chief Medical Officer, acting as senior advisor on and being responsible for all medical matters.
John Carpenter (Click name for full details)
Company: John Carpenter Medical Communications
Qualifications: BSc, PhD
John, a pharmacologist, was a lecturer in pharmacology at Manchester University from 1974 to 1992, where he studied drugs and the movement of ova through oviducts, anti-asthma drug models, and the pharmacokinetics of alcohol (never a shortage of volunteers). He has written or contributed to several pharmacology textbooks, and acted as an expert witness in court cases involving alcohol. In 1992, he became a full-time medical writer, initially with Gardiner-Caldwell Communications, then as Medical Team Director at Medical Action Communications and briefly as Medical Director at OCC. Since 2001, he has been a freelance medical writer, medical communications consultant, and trainer. John is a regular contributor to the range of training courses offered by the Proper Medical Writing Group in Poland and by Kemic Bioresearch in Canada. Satisfied customers include the Canadian Government’s medicines regulatory department. He has served on the EMWA Executive Committee as Universities Liaison Officer and was a member of the EMWA Professional Development Committee (EPDC) from 2005 to 2010.
Siddharth Chachad (Click name for full details)
Company: Dr Reddy’s Laboratories
Qualifications: MBBS, MSc, DPMM, CIPM
Siddharth has experience in clinical development of new healthcare products including innovative drugs, generics, biologics and vaccines. His understanding of global clinical requirements has yielded successful product registrations in most regulated markets across the globe including EU and US. He also has extensive drug safety experience in clinical trials as well as in post-authorisation setting. He has been clinical and nonclinical signatory to 1000+ expert reports and authored many scientific publications over the last decade. Siddharth is a Fellow member of PIPA and an Affiliate Member of Faculty of Pharmaceutical Medicine, UK. He is also a committee member of EMWA Pharmacovigilance Special Interest Group (PV SIG).
Lisa Chamberlain James (Click name for full details)
Company: Trilogy Writing & Consulting
Qualifications: PhD
Lisa Chamberlain James is a Senior Partner and CEO of Trilogy Writing & Consulting Ltd. Aside from management activities, she also leads client projects, with extensive experience in a variety of documents, and with a special interest in drug safety and patient information. After receiving her PhD in Pathology, Lisa began her medical writing career in Cambridge in 2000. Since then she has also been involved in the European Medical Writers Association (EMWA). As a member of the EMWA Educational Committee, a leader and assessor of EMWA workshops, a mentor of EMWA workshop leaders, has helped to produce the EMWA conference programme from 2010 onwards, and holds an EMWA personal development certificate. Lisa is also a member of TOPRA and PIPA, is the founder of the EMWA PV Special Interest Group and Geoff Hall Scholarship Committee, and is a Fellow of the Royal Society of Medicine.
Helen Chambers (Click name for full details)
Company: Costello Medical
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Helen joined Costello Medical as a medical writer in 2013, following a period of post-doctoral research at the University of Cambridge in the field of biochemistry and work as a clinical geneticist in a diagnostic laboratory. Since then, she has applied the experience of scientific writing which she gained in academia to the medical communications sector, developing and overseeing the delivery of a range of materials including manuscript, abstracts and scientific presentations for display at global congresses, as well as for use at smaller meetings such as advisory boards.
Julie Charlesworth (Click name for full details)
Company: A Tree of Life Sciences Ltd
Qualifications: PhD
Julie is the Founder and Director of A Tree of Life Sciences®, a consultancy offering medical writing and project leadership/management expertise. Julie started out as a biochemist and cancer research scientist. She has over 25 years’ experience in the life sciences, pharmaceutical and healthcare industries. She held a number of permanent posts in Big Pharma leading multi-disciplinary internationally dispersed teams in global project management and clinical research. As a research scientist in academia and industry, she was an author of scientific publications. Julie has been a medical writer and has gained a range of experience of regulatory documents and medical communications. She re-launched her career to provide project management expertise and writing to the life-sciences sector, and in 2014 founded A Tree of Life Sciences Ltd. Julie continues her involvement in professional networks such as EMWA, MedComms events and leadership initiatives. Julie has been a member of EMWA since 2010. In 2016 she took on EMWA roles as Freelance Advocate, co-editor of the ‘Out On Our Own’ section of Medical Writing and co-host of the Freelance Business Forum. As a freelancer herself, Julie has been there before and back again in the ‘freelance world’ at different stages of life and career.
Sarah Chen (Click name for full details)
Company: Publicis Life Brands International
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Sarah Chen has been working in the pharmaceutical industry for over 15 years. Starting her career in clinical research in the United States, she made a leap into the world of medical communications and marketing when she moved to Europe 10 years ago. Based in Paris, she has gained experience in several global advertising agencies and is currently working with Publicis Life Brands International. She has helped launch a vast number of pharmaceutical brands over the years on diverse, increasingly digital, platforms. She is an expert on the promotional side of medical communications and medical writing for pharmaceutical marketing. While her main focus is on global and international business, she also interacts with individual, local European markets and their specific challenges, needs and regulations
Diarmuid De Faoite (Click name for full details)
Company: Smith & Nephew
Qualifications: MBS, BBS, BA
Diarmuid is the EMWA website manager and has been a member of the EMWA Executive Committee since 2012. Originally an academic researcher on the subject of entrepreneurship, Diarmuid has worked as a business lecturer and researcher, online editor, print editor, and as a medical and general freelance writer in Ireland, Germany and Switzerland. His current position focuses on developing a network of high-performing clinical research sites around the world.
Katrina de Saram (Click name for full details)
Company: AXON Communications
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Katrina has over 11 years’ experience in healthcare communications, following completion of a PhD focusing on endothelial dysfunction and the role of oxidative stress in type 2 diabetes. During this time, Katrina has delivered a broad variety of projects for global pharmaceutical companies to support the launch and life-cycle management of their products across several therapeutic areas including type 2 diabetes, haemophilia, Alzheimer’s disease and oncology (breast cancer). As an Associate Director at AXON, Katrina acts as technical lead to ensure high-quality editorial content and provides strategic leadership for tailored educational programmes. Katrina brings a wealth of experience in developing strategic communication plans designed to disseminate complex scientific information to a range of target audiences. As part of her role, Katrina provides training on Good Publication Practice as well as pharmaceutical Codes of Practice relating to the evolving compliance landscape.
Martin Delahunty (Click name for full details)
Company:
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John Dixon (Click name for full details)
Company: Libra Communications Training
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John qualified in medicine having studied at Oxford University and Guy's Hospital, London. Initially he trained as a surgeon. After gaining further experience in paediatrics, neonatology, obstetrics and gynaecology, he then became a GP. Since 2003, John has completed an MBA at Warwick University Business School. He then spent five years as Director of Medical Communications at InterComm International Ltd., becoming a healthcare communications consultant and trainer in scientific writing in 2013. His consulting and training interests include supporting researchers, medical communications agencies and medical equipment companies to ensure their scientific communications are accurate, understandable and use appropriate language. John provides training for universities and research institutes across Europe in academic writing, presentation delivery, and conference abstract and poster preparation. He is coauthor of How to Publish in Biomedicine. 500 Tips for Success. 3rd Edition (2016). CRC Press.
Julia Donnelly (Click name for full details)
Company: Julia Donnelly Solutions Limited
Qualifications: PhD, BPharm
Julia runs her own medical communication company (Julia Donnelly Solutions Limited) and works predominantly for the pharmaceutical industry. Previously she has worked as a medical writer, project leader, editorial director, technical director and global resource, training and development director in international medical communications. She is an experienced medical writer and trainer, has developed over 40 publication plans and frequently develops the outputs from the plans she manages. Julia served on the EMWA Professional Development Committee (EPDC) 2005-2010 and is a past President (May 2014-2015).
Barry Drees (Click name for full details)
Company: Trilogy Writing & Consulting GmbH
Qualifications: PhD, Editor in the Life Sciences
Barry Drees was a witness to the start of the genetech madness when he got his PhD in molecular genetics at the University of California at San Francisco at the time of the founding of Genentech. Life's sense of irony took him to Germany, however, where he worked as a medical writer in the pharmaceutical industry for 12 years, setting up a Phase I writing group and leading several regulatory submission teams, among other activities. Barry is a frequent speaker on medical writing, statistics and other scientific communication topics for Management Forum Ltd, as well as various pharmaceutical associations. He also speaks on non-scientific topics such as the introductory presentation on the history of Malta at the 20th EMWA conference. He has appeared on an educational television programme in Germany to discuss the ethics of genetic engineering and German radio to discuss medical writing as a career. He is the former Editor-in-chief of ‘The Write Stuff’, the Journal of EMWA (now called ‘Medical Writing’), and is currently a Senior Partner at Trilogy Writing & Consulting. He served on the EMWA Professional Development Committee (EPDC) 2006-2009, with a focus on Train-the-Trainer events. Barry is a Nick Thompson Fellow of EMWA.
Gaële Ducher (Click name for full details)
Company: Scinopsis
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Gaele is a principal medical writer at Scinopsis. She worked in academic research for 10 years, in France, the UK, Australia and the US, with a specific interest in rheumatology, paediatrics, medical imaging and sport sciences. Gaele has a doctoral degree in physiology and published approximately 30 scientific articles during her research career. She has been a medical writer since 2011 and is experienced at writing a wide range of regulatory documents and medical communications covering various therapeutic areas.
Claire Dyer (Click name for full details)
Company:
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Jane Edwards (Click name for full details)
Company: BSI
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Jane holds a BSc in Chemistry and an MBA from Durham University. She has over 13 years’ experience in the medical device industry, having previously worked for Coloplast in their ostomy and continence business. Jane’s experience includes working within the pharmaceutical, chemical and telecoms industries for Glaxo Wellcome, ICI and Ericsson, allowing her to bring depth of knowledge from across many industries and technologies. Her current role in BSI involves designing and implementing the Global Medical Devices internal and external communications strategy working closely with Global Notified Body teams and the wider BSI structure to ensure all content is effective and compliant.
Vivien Fagan (Click name for full details)
Company: QuintilesIMS
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Vivien has 22 years of experience in an international CRO and, over the past 19 years, has written numerous regulatory documents (including protocols and CSRs) for all phases of studies for a variety of pharmaceutical sponsors and biotechnology companies. In her current position as Director, Global Medical Writing, Vivien manages IQVIA’s Medical Writing group based in Livingston, Scotland. She is the also Global Head of IQVIA’s Clinical Trial Disclosure group. From May 2014, Vivien was a member of the Budapest Working Group CORE Reference de novo Review Team.
Tracy Farrow (Click name for full details)
Company: PPD
Qualifications: GIBiol
Tracy is currently Senior Director, Medical Writing for PPD where she is responsible for EMEA and APAC medical writing and PPD’s global data transparency initiative. Tracy has more than 25 years of Biomedical Science experience. Before PPD she worked for ClinTec International as Manager, Medical Writing Services; and Pfizer as Medical Writing Therapeutic Area Lead, and Quality Manager for Data Management where she was responsible for data privacy training, audit management, SOP and best practice development. She lectured in Intermediate Laboratory Data Management for the Association for Clinical Data Management for a number of years as part of their professional development program. She attained her 2.1 (Hons) GI Biol in Biochemistry in 1993 after gaining two Higher National Certificates in Haematology and Chemistry. From May 2014, Tracy has been a member of the EMWA-AMWA Budapest Working Group Oversight Review Team, with special responsibility for the area of transparency and public disclosure in relation to clinical-regulatory documents.
Douglas Fiebig (Click name for full details)
Company: Trilogy Writing & Consulting GmbH
Qualifications: PhD
After 8 years in academic research (much of the time spent wading in rivers), Douglas was fortunate to chance upon a job advert that would launch his career in medical writing. It soon became clear to him that, in addition to keeping his feet dry, working as a medical writer was surely the most enjoyable way to earn a living using his scientific and linguistic skills. He has been involved in regulatory medical writing since 1996. Together with two partners, he took the plunge in 2002 and established Trilogy Writing & Consulting, a specialist medical writing company. Many years of writing pre- and post-submission documentation provide the inspiration for his EMWA workshops. Douglas served on the EMWA Professional Development Committee (EPDC) from 2009 - 2013.
Julia Forjanic Klapproth (Click name for full details)
Company: Trilogy Writing & Consulting
Qualifications: PhD
Julia Forjanic Klapproth is a poet and scientist who stumbled onto medical writing in 1997. With a PhD in developmental neurobiology and a passion for writing, she enjoys the challenge of grappling with the science while crafting it into easily understandable text. Julia has worn various guises for the good of EMWA over the years including being President of EMWA (2007-2009 and in 2002). In 2002 she also co-founded the medical writing company Trilogy Writing & Consulting in Germany and is a Senior Partner. Julia is passionate about medical writing and teaches writers on a broad range of topics, from study protocols to interpersonal skills, focussing on the essence of the topic at hand. Her basic premise in training is to help participants recognise what their documents are meant to be and for whom they are writing them.
Nicky French (Click name for full details)
Company: Freelance
Qualifications: PhD
Nicky started life as a medical information officer with Knoll Pharmaceuticals, before moving to Cambridge to start her writing career with Napp Pharmaceuticals. After four years, Nicky made the move from industry to agency, spending six years with Complete Medical Communications in Glasgow and two years with Adelphi Communications in Bollington. She is currently a freelance medical writer and has worked across a number of therapy areas on a diverse range of projects, including regulatory, marketing, training and educational materials, and publication planning and strategy.
Claudia Frumento (Click name for full details)
Company: ICiMT International Communication in Medicine and Technology
Qualifications: PhD
Claudia is an electronic engineer and has a PhD in medical information technology. She graduated from the University of Buenos Aires and received a German scholarship to do her PhD thesis in the University of Heidelberg. She has more than 16 years experience in the field of medical technology acquired as Product Manager and European Training and Education Manager for international medical technology corporations, Guidant and Medtronic, and has been a lecturer at the University for Applied Sciences Giessen–Friedberg (International B2B Marketing and Business English for Mechanical and Industrial Engineers). She speaks three languages fluently (English, German and Spanish) and has vast experience in international project management such as: product launches, pan-European training programmes for physicians, multicentre clinical trials and writing for the medical device and pharmaceutical industries. She was a member of EMWA’s EPDC and leads two workshops focused on Medical Devices.
Neil Garrett (Click name for full details)
Company: Covance
Qualifications: PhD
Neil's first experience of medical writing was in the field of medical communications where he put to good use the skills and knowledge he acquired during several years of medical research. After exposure to the “marketing” side of writing, he decided to broaden his writing horizons and switched to regulatory writing where he has experience of working in both the pharma and CRO environment. Neil has over 15 years of medical writing experience including many years of working on post-submission writing activities, which provided the inspiration for conducting this workshop.
Susanne Geercken (Click name for full details)
Company: Pfizer Pharma GmbH
Qualifications: MA
Susanne worked for a small Washington-based magazine in the US, the Translation Department of the United Nations in NY and a Frankfurt bank before she joined Pfizer as a medical translator in 1994. In her role as Manager Translations and Procedures she has been responsible for internal translation, outsourcing, standards and quality control of translation projects. Susanne currently works for the Drug Safety Department within Pfizer Germany. Susanne has also acted as Pfizer in-house trainer for workshops on medical English. To help give future medical translators hands-on-experience in the industry, Susanne established a translation internship program in the Pfizer Karlsruhe Clinical Research Department and served as mentor. She has also given seminars and presentations for the university translation studies program and the Germany Association of Professional Interpreters and translators. Languages are Susanne's passion. She is a trained translator for English and Spanish and also speaks French and Portuguese.
Art Gertel (Click name for full details)
Company: MedSciCom, LLC
Qualifications: PhD
Art has a background in neurophysiology and behavioural medicine. As an independent consultant, he specialises in regulatory strategy, Data Safety Monitoring Board management, medical writing, and bioethics. Art has held senior posts at a number of companies including Schering-Plough, Hoffmann-LaRoche, TFS, and Quintiles, and headed departments responsible for medical writing, project management, and regulatory affairs. He also served as a Senior Research Fellow with the Centre for Innovation in Regulatory Sciences (CIRS). He has extensive teaching experience and has presented to professional organisations (e.g. EMWA, AMWA, DIA), and corporate and academic audiences, worldwide. He spent 2 years heading Clinical Operations for an eDC ‘dot.com’ company and has been active in CDISC since its inception. He serves as Co-Chair of the Global Ethics and Regulatory Initiative (GERI) of the Alliance for Clinical Research Excellence and Safety (ACRES). He is a Founding Member of the Global Alliance of Publication Professionals (GAPP), a Past President of AMWA and a Fellow of both AMWA and EMWA. More recently, he served in a Senior Advisory capacity on the Budapest Working Group in developing the CORE Reference. He has a particular interest in bioethics in the context of clinical studies, and serves on a number of task forces focusing on improving the drug development process while protecting the rights and safety of clinical study participants.
Barbara Grossman (Click name for full details)
Company: Hawkeye Medical Limited
Qualifications: BSc
Barbara Grossman has a passion for proofreading, quality control, and education. She started Hawkeye Medical Limited, a medical writing and consultancy business, after working for a medical publishing company and contract research organisation, building up and managing its medical writing group. Barbara runs professional development training for companies and educational institutions. She was awarded an EMWA fellowship in 2005, was Treasurer 1998–2005, has been an EMWA workshop leader since 2001, served on EMWA’s Education Committee 2010–2018, was the Education Officer for 2 years until 2016, and since May 2018 is EMWA’s Vice President. In addition, Barbara is an Associate Editor of Medical Writing, EMWA’s journal.
Claire Gudex (Click name for full details)
Company: University of Southern Denmark
Qualifications: MBChB, PhD
Claire is assistant professor in Academic Writing and health service researcher in the area of patient outcome measurement. She has a medical degree and worked for 10 years at the Centre for Health Economics, University of York, UK, before moving to Denmark in 1995, where she has worked at WHO Regional Office, National Institute of Public Health, and the University of Southern Denmark. Claire is a founder member of the EuroQol Group, an international research group for the development of the generic health measure, EQ-5D. She is section editor for the ‘Teaching Medical Writing’ column in the EMWA journal Medical writing.
Sam Hamilton (Click name for full details)
Company: Sam Hamilton Medical Writing Services Ltd
Qualifications: PhD
Sam Hamilton is a postdoctoral virologist and director of her UK-based medical writing consultancy. With over 24 years in clinical and regulatory medical writing roles in the pharmaceutical industry, Sam headed UK Medical Writing for a large CRO until setting up on her own in 2006. Sam has a special interest in the area of public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the open-access www.core-reference.org in May 2016. CORE Reference is the only known open-access resource that pinpoints the sections in an ICH E3-compliant CSR that are potentially affected by public disclosure. Sam is long-time supporter of EMWA serving in various roles over 12 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW; journal); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President of the Executive Committee (EC). Sam was elected an EMWA Lifetime Fellow in 2018 for her services to the association, and is currently MEW Section Editor for the “Regulatory Public Disclosure” Section and on the Advisory Panel of the Regulatory Public Disclosure Special Interest Group
Sabrina Heisel-Stöhr (Click name for full details)
Company: Merck KGaA
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Sabrina is a biologist by training. She received her doctoral degree in human genetics and pursued her postdoctoral research at the German Cancer Research Centre in Heidelberg. After an advanced training degree in clinical research, she became a Medical Writer at Boehringer Ingelheim. In 2016, Sabrina joined Merck to continue her regulatory medical writing career as Medical Writing Lead for biosimilars and oncology. Sabrina has been involved in document writing across all stages of clinical development and in various indications. She has > 5 years of experience in regulatory medical writing and > 10 years of experience in oncology.
Susanne Herzig (Click name for full details)
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is a physician who worked in hospitals in internal medicine and surgery before joining pharmaceutical research. For over 20 years, she has worked for contract research organisations in project management, safety and medical writing. She is currently a Senior Medical Writer at ICON Clinical Research in Germany. In her current position, Susanne has been involved with developing adaptive study designs for various indications, including writing of the study protocols and Informed Consent Forms (ICFs), designing the case report forms, advising the study teams during the clinical phase of the study on medical and statistical aspects, compiling updated ICFs and protocol amendments, where necessary, based on the interim results up to writing final reports that take into account the results of interim analyses and the decisions of sponsors that were based on these results and the recommendations of Expert/Independent Advisory Committees. Moreover, Susanne has prepared and moderated meetings with regulatory authorities during which sponsors suggested adaptive designs. Based on comments from authorities, she has been involved in re-designing adaptive protocols and in meetings to explain and defend the rationale and benefit for using adaptive designs.
Marian Hodges (Click name for full details)
Company: Medwrite
Qualifications: BSc
Marian is a publishing consultant, with particular interests in training and preparing clear content tailored for the audience. She has many years of experience of medical writing and editing. Until April 2018 Marian was Associate Director for Publishing at the UK’s National Institute for Health and Care Excellence, where she built up and managed the editorial and digital publishing teams. Marian set up EMWA’s first website in 1997, and has been an EMWA workshop leader since 2001. With Barbara Grossman, Marian has run over 30 EMWA workshops on editing. She was awarded an EMWA fellowship in 2007, and is currently the Education Officer on EMWA’s Executive Committee, and chair of the Education Committee.
Sarah Hopwood (Click name for full details)
Company: Scinopsis
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Sarah is head of medical writing at Scinopsis, a consultancy based in France and the UK. Sarah began her medical writing career in 2006, initially working in a busy international medical communications agency before joining the Scinopsis team in 2009. Prior to medical writing, she worked as a post-doctoral research scientist and authored numerous scientific publications in the field of neuroscience. Sarah is very experienced at writing a wide range of regulatory documents and medical communications covering many different therapeutic areas. She has been an active member of EMWA since 2007.
Martin Huber (Click name for full details)
Company: BfArM and PRAC
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Pharmacovigilance Division PRAC Member, and Federal Institute for Drugs and Medical Devices (BfArM), Germany. Martin is the German member of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Being a pharmacist by training and holding a degree in public health he gathered detailed experience in pharmacovigilance in a hospital setting before entering BfArM in 2010. Since 2013 he is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors'.
Adam Jacobs (Click name for full details)
Company: Premier Research
Qualifications: PhD MSc CStat CSci Dip IoD Dip Econ
After getting bored of his first two careers (organic chemistry research and medical translating), Adam worked as a medical writer, first at a small contract research organisation and then at a large medical communications agency. He set up his own business in 1999, which was a lot of fun for a while but sadly didn’t survive the recession and ceased trading in 2014. Adam was EMWA President in 2004–2005 and was co-author of EMWA’s guidelines on the role of professional medical writers in publications. He finally got bored of medical writing as well, and now works as a statistician. However, he doubts he will ever get bored of coming to EMWA conferences.
Angela Jennings (Click name for full details)
Company: Syne Qua Non
Qualifications:
Angela is the Director of Quality and Process Improvement at Syne Qua Non, a niche clinical biometric contract research organisation based in Diss, Norfolk, UK. The company works with global pharmaceutical companies and smaller discovery and development companies. Her knowledge and experience spans Good Clinical Practice, Good Laboratory Practice, Good Research Practice and the ISO International Standards. Upon completion of her PhD, Angela worked in the pure research arena before moving into pharmaceutical research and development and then into various contract research organisations as a quality manager. Angela is a Fellow of the RQA and was on the Board of Directors with a portfolio covering European quality assurance, strategy and programme activities. She has been a member of the RQA publications committee and has co-authored and edited numerous publications by the RQA. She has acted as Course Principal for the ‘GLP for the Analyst’ RQA Professional Development course, tutor for the ‘GLP for Study Directors, Principal Investigators, Study Staff and Management’ course and is currently a tutor on the MSc Quality Management in Scientific Research programme at Cranfield University.
Jackie Johnson (Click name for full details)
Company: JLJ Consultancy
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Jackie is a freelance medical writer and managing director of JLJ Consultancy. She specializes in medical communication deliverables for international pharmaceutical clients and biotech companies. Jackie received an undergraduate degree in Biology from The Ohio State University, completed a PhD in Cancer Biology at The University of South Florida, and did her postdoc at the Netherlands Cancer Center in Amsterdam, Netherlands.
Debbie Jordan (Click name for full details)
Company: Freelance - Debbie Jordan Ltd
Qualifications: BSc (Hons), MIBiol, CBiol, Dip Clin Sci
Debbie has been working in the pharmaceutical industry for over 25 years in both pharmaceutical company and CRO environments. She has worked as a data assistant, CRA and project manager, before moving into medical writing. Eighteen years ago she set up her own medical writing company and now works on all aspects of medical writing from clinical development programmes and regulatory packages through to marketing and conference material. Debbie also provides training in medical writing and associated topics to a variety of organisations. Debbie served on the Executive Committee of EMWA for 2 years between 1997 and 1999.
Luise Kalbe (Click name for full details)
Company: GlaxoSmithKline Vaccines
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Luise Kalbe has two Masters and a PhD in biochemistry and speaks six languages. She has work experience in academic research and the industry in different disease and vaccine areas, at the European Commission, and as a mathematics and science teacher. Currently working at GSK in publication management, she has led several workshops and trainings in publication writing at GSK over the past years and a workshop at EMWA in 2014.
Wendy Kingdom (Click name for full details)
Company: Freelance
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Wendy has more than 30 years’ experience of clinical research and medical writing in the pharmaceutical industry. She started her career as a clinical research associate; writing protocols, preparing related study documents, managing studies, and writing clinical study reports. She has been working successfully as a freelance medical writer since 2002 and specialises in clinical and regulatory documents. She has provided commercial and academic training on medical writing. Wendy was EMWA Education Officer 2003–2005, served on the EMWA Professional Development Committee (EPDC) for 5 years, and was Treasurer of EMWA from 2005–2009.
Maria Kołtowska-Häggström (Click name for full details)
Company: Proper Medical Writing
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Maria is a co-owner of Proper Medical Writing, the first Polish medical writing agency, and an independent consultant, affiliated to the Department of Women’s and Children’s Health at Uppsala University, Uppsala, Sweden. In 1991, she began working within the pharmaceutical industry where she gained experience in both the marketing and medical sides of the business. Between 2001 and 2013, Maria worked at Pharmacia (later Pfizer) in Stockholm, Sweden, where she was responsible for large research databases and patient registries. Maria led numerous research groups investigating growth hormone disorders based on real-life clinical data. She has an extensive track record of quality of life and patient-reported outcomes research. Furthermore, she lectured at different meetings related to late phase drug development and patient registries. She is a member of the European Medical Writers Association, European Association of Scientific Editors, European Society of Endocrinology, and Growth Hormone Research Society. She is also a reviewer for a number of peer-reviewed journals, an Associate Editor for BMC Endocrine Disorders and a section editor for Medical Writing.
Jules Kovacevic (Click name for full details)
Company: ERGOMED Plc
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Jules has been working in the CRO environment since 2006, focussing in medical affairs and medical writing. She has been actively involved in writing, budgeting, resourcing and training in medical writing for the last 10 years. Successfully setting up teams in a variety of organisations and being actively involved in the development of individual writers development has become a major part of her working life. In her current role as Head of Medical Writing at Ergomed, she has managed, trained and developed a global team of medical writers of varying experiences, both employees and contractors. Jules is eager to share the team model that is focussed on personal development in order to promote a positive work environment, staff satisfaction; staff retention, skill development and a clear career path within the medical writing function.
Carola Krause (Click name for full details)
Company: Codex Biomed
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Based in Potsdam, Germany, Carola Krause has been offering a professional biomedical writing consultancy service to academia and the pharmaceutical industry since 2016. Carola is a postdoctoral molecular cell biologist with hands-on experience in basic and pharmaceutical research and development. Her multidisciplinary background in academic and pharmaceutical project management, and clinical trial coordination provides her with key insights into all phases of the drug development process and its regulatory requirements. She has 12 years of experience in the biomedical communication sector, and has attended EMWA workshops on regulatory medical writing since 2014. Carola has been supporting the EMWA Public Relations team as LinkedIn Manager and recently joined the Freelance Business Group subcommittee.
Elisabeth Kuhn (Click name for full details)
Company: Boehringer Ingelheim
Qualifications:
Elisabeth is a biologist by training and received her PhD in the field of oncology, focusing on paracrine cell-cell interaction. After having experienced the benchside of research for several years, she decided to move over to the bedside and help to bring innovative drugs to market. As she always enjoyed the interpretation and presentation of data, medical writing was a perfect fit. Since 2012, she has been working as a regulatory medical writer at Boehringer Ingelheim Pharma GmbH & Co. KG. She is involved in various oncology projects across different indications and writes Phase III CSRs and clinical summary documents.
Elise Langdon-Neuner (Click name for full details)
Company: Freelance editor and publications consultant in biomedical sciences
Qualifications: BSc, Editor in Biomedical Sciences
Elise has a keen interest in biomedical journal policies. She was managing editor for the leading European diabetes journal, Diabetologia, and a new medical journal published by Elsevier, where she established the journal’s policies and procedures. Before becoming a freelance editor and publications consultant she worked with researchers at Baxter preparing manuscripts and advising on publication. She is a member of COPE and WAME and the EASE Editorial Board. She regularly publishes articles and gives presentations on publications ethics, wrote the editorial policy chapters in the EASE editor’s handbook (2013) and the contributions on English as an additional language to the 4th Edition of ‘Medical Writing: a prescription for clarity’ (2014). Last but not least she survived 9 years of editing EMWA’s journal ‘The Write Stuff’ (now ‘Medical Writing’).
Magali Le Goff (Click name for full details)
Company: Scinopsis
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Magali is currently working as a Principal Medical Writer at Scinopsis in France. After getting an engineering diploma in Chemistry and an MSc in Biotechnology, she obtained a PhD in the field of Ophthalmology/Biochemistry. She then worked as a post-doctoral fellow at the University of Manchester in the UK for 10 years before making a career change to Medical Writing in 2012. Over the years, she has gained great experience in a wide range of both regulatory and medical communication documents in therapeutic areas including ophthalmology, dermatology, respiratory diseases and oncology. During her academic years, she has served as a reviewer for scientific journals and published 12 articles from her own research including 2 reviews.
Ute Lemke (Click name for full details)
Company: Boehringer Ingleheim
Qualifications: PhD
After studying agrobiology, Ute obtained a PhD for analysing livestock production systems in Vietnam. Combining an interest in biology and statistics with a fascination for languages and the written word, medical writing was (in hindsight) the most logical career development. Ute joined Boehringer Ingelheim more than 7 years ago as a medical writer. Discovering her liking for the job, she has stayed on; since 2012, she has held the position of senior medical writer. Ute has worked almost exclusively in oncology for the past 6 years, writing clinical trial reports for all phases and clinical submission documents for drugs in various oncology indications.
Phil Leventhal (Click name for full details)
Company: 4Clinics France
Qualifications: PhD
Phil is currently a Scientific Writer at 4Clinics France in where he specialises in publications writing. He has more than 10 years’ experience as a medical writer, has authored and edited hundreds of peer-reviewed articles, and has worked extensively with, and trained, non-native English speakers in scientific writing. Before transitioning to scientific writing, Phil worked for 15 years in the United States as a biochemist and cell biologist in academic and pharmaceutical research. In addition to his work for 4Clinics France, Phil is currently Editor-in-Chief of EMWA’s official journal, ‘Medical Writing’.
Christopher Marshallsay (Click name for full details)
Company: Grünenthal GmbH
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A PhD biochemist, currently working as Director, Head Medical Writing and Public Disclosure at Grünenthal (Aachen, Germany), Christopher Marshallsay has 20 years of experience in various roles in clinical development - including pharmacokinetics, medical writing, clinical trial disclosure, and as department/function head - whilst located in Aachen, Frankfurt, and Paris. He previously worked at Ciba-Geigy, Aventis, and Sanofi. Christopher is an expert in continuous improvement and an experienced lecturer and workshop leader. In his current role he manages the team responsible for clinical trial disclosure in English-language trial registries worldwide, and drives alignment of company processes and standards to enable smart trial registration, status updating, and results reporting.
Catherine Mary (Click name for full details)
Company: Avicenne
Qualifications: PhD
Catherine Mary is medical writer who wears both a scientist’s and a journalist’s hat. She obtained her PhD in virology in 1994 and then worked as a journalist for the French magazine "Biofutur" before becoming a freelance medical writer in 1997. Her contributions have ranged from conference co-ordination and reporting, marketing, and educational materials, to popularisation of science and medicine, often working alongside illustrators and multimedia designers. Her clients have included pharmaceutical industry, public health institutions, and governmental departments and agencies. She has covered a wide range of public health and environmental fields, including such diverse areas as education, sexuality, prevention of obesity, emerging infectious diseases (particularly avian flu) and genetically modified plants.
Anne McDonough (Click name for full details)
Company: McDonough Clinical Research Ltd
Qualifications: BA, MPH
Anne is a medical writer with over 25 years of experience in a wide variety of therapeutic areas for clients ranging from emergent biopharma companies to multinational corporations. She has worked in a number of research roles (writing, clinical science, operations, compliance, and training) and has settled on medical writing as the most enjoyable of them. Her experience includes dozens of healthy volunteer studies (PK/PD, microdosing, thorough QT, food effect, bridging, etc.). Anne writes across the continuum of clinical research from operational documents to clinical study reports, nonclinical and clinical CTD modules, and manuscripts. She has also worked with nonprofit organisations and academia on conference reports, manuscripts, clinical support tools, and training and evaluation materials.
Alison McIntosh (Click name for full details)
Company: ICON Clinical Research
Qualifications: BSc (Hons), PhD
Alison has been a medical writer for the pharmaceutical industry for more than 20 years and has written extensively for regulatory authorities, and other audiences. She became a medical writer after completing her PhD and a further 5 years of postdoctoral research in molecular virology. She joined GlaxoWelllcome (now GlaxoSmithKline) as a medical writer in 1995, then from 2000 worked as a freelance medical writer and consultant. Alison joined ICON Clinical Research in 2014 as a Principal Medical Writer.. Her wealth of experience as a medical writer encompasses many different types of documents including manuscripts, book chapters, and clinical and scientific abstracts, as well as clinical study reports, investigator brochures and other regulatory documents. Alison is a section editor for the EMWA journal Medical Writing and has previously served on the EMWA Professional Development Committee.
Stuart Mealing (Click name for full details)
Company: Oxford Outcomes (ICON Plc)
Qualifications: MSc
Stuart has worked in the field of health economics since 2004, initially in academia and then in the commercial sector. Stuart leads a team of health economic modellers at ICON Plc and has published the results of his analyses in a range of clinical and health economic journals. He has also been involved with the preparation of numerous submission dossiers for NICE and other authorities.
Monica Milani (Click name for full details)
Company: Apropos Science
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Monica has been a medical writer since 2011. She began her career in a busy medical writing company, moved to the pharmaceutical industry, and recently transitioned into freelancing. She has experience in a wide range of regulatory and medical communication documents covering various therapeutic areas. Prior to medical writing, she worked in academia and authored numerous articles in the immunology and oncology fields. She was editor-in-chief of the open access journal Drug Target Insights from 2008 to 2011, and served as a reviewer for several peer-reviewed journals. Monica holds degrees in biological sciences, biotechnology and scientific/technical communication.
Stephanie Millican (Click name for full details)
Company: MHRA
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Rabiah Mirza (Click name for full details)
Company: Synergy Medical
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Rabiah is currently working for Synergy Medical, a medical communication agency managing projects and creating content for inflammation products. Previously, Rabiah was creating content for a digital specialist agency, PharmiWeb Solutions and prior to this, at Bristol-Myer Squibb within the cardiovascular therapy area. Having worked at the global level, it was vital to collaborate with local Medical Information teams, including US, EU and Australia. Regulatory Writing experience was obtained at PARXEL International and Chiltern International. Both her BSc. Biomedical Sciences and MSc. Clinical and Experimental Medicine were received at University College London.
Shanida Nataraja (Click name for full details)
Company: AXON Communications
Qualifications: BSc, PhD
Shanida became a medical writer more than 15 years ago, after completing a PhD and a 2-year postdoctoral research fellowship focusing on the neurophysiology of learning and memory. During this time, Shanida has had the opportunity to work on a wide range of medical communications, marketing, public relations, clinical trial communications and market access activities in numerous therapeutic areas, particularly oncology and cardiology. Currently, Shanida is a Director at AXON Communications, a global healthcare consultancy firm, where she is responsible for, amongst other things, providing scientific, strategic and editorial input into new and existing accounts, as well as leading internal training and an external training, coaching and facilitation offering delivering pragmatic bespoke solutions that help organisations to compete, grow and win business, and cope with change. Shanida has been involved in numerous strategic communication workshops for key pharmaceutical brands, as well as developing strategic communication plans to support clinical trial recruitment and retention, raise awareness of educational initiatives, and enhance internal and external communications with key stakeholders. Shanida has been a member of EMWA since 2001, and between 2006 and 2012, Shanida was EMWA's website manager. As such, she was a member of EMWA's Executive Committee for 6 years, and she is also an experienced workshop leader, having run several workshops during her time with EMWA.
Janet Nooney (Click name for full details)
Company: MHRA
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Etienne Ouimette (Click name for full details)
Company: Health Canada
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Andrea Palluch (Click name for full details)
Company: Kinapse UK Ltd
Qualifications: MSc
Andrea got her first job in the industry in 1999 armed with a degree in genetics, and an interest in molecular biology and immunology, as well as in clinical and applied research. Working as a CRA for 6 years and as a medical writer for the last 9 years, she gained considerable experience of pharmacogenomic studies during the decade which saw most advances in the human genome project. Andrea has previously served as EMWA’s PR officer (2009-2011) and is now a member of the EMWA Professional Development Committee.
Jerry Parker (Click name for full details)
Company: Novartis
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Jeremy Parker is currently Head of Periodic Safety Reporting for Novartis. Jeremy has worked in the Pharma industry for over 20 years, much of it within Medical Writing functions. He has gained experience ranging from early development through to post-marketing lifecycle management. He gained a certificate from the EMWA professional development programme in 1995. For the last 5 years Jerry has led the Periodic Safety Reporting Group in the Pharmacovigilance department of Novartis. One of the early responsibilities was to implement the new GVP Module VII guidelines for the production of PBRER-format PSURs.
Iain Patten (Click name for full details)
Company: Freelance
Qualifications: PhD
Iain Patten is an independent medical writing and translation consultant based in Valencia, Spain. He trained as a biomedical scientist in the UK and undertook research in neuroscience and embryology before shifting his attention to scientific communication. He worked for a number of years in Spain as an editor and translator of biomedical science and later in the UK in the medical communications industry. He currently offers an integrated writing-support service for scientists and clinicians, with services ranging from scientific consultancy, through translation and editing, to medical and scientific writing.
Laia Pedro-Roig (Click name for full details)
Company: Trilogy Writing & Consulting
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Laia Pedro-Roig has a Degree in Chemistry from the Universitat d’Alacant and a PhD in Biochemistry and Molecular Biology carried out at the Universitat d’Alacant, University of Florida, and Goethe Universität (Frankfurt, Germany). Following her PhD, she moved to a post-doctoral position at the Medical Research Council (UK). Overall, Laia has 10 years of research experience in cell signalling, including preclinical drug development in the Parkinson’s disease area. She is currently a medical writer at Trilogy Writing & Consulting.
Elisabeth Penninga (Click name for full details)
Company: Danish Medicines Agency
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Elisabeth Penninga, MD, is Chief Medical Officer at the Danish Medicines Agency, Department of Medical Evaluation & Biostatistics, Copenhagen, Denmark. Dr. Penninga has clinical experience in neurology, endocrinology, geriatric and internal medicine, and is a specialist in clinical pharmacology. Dr. Penninga has authored several international publications, including peer-reviewed articles, review articles and meta analyses. Since 2012, she has worked for the Danish Medicines Agency as a medical assessor. She has extensive experience in assessment of the clinical pharmacology, efficacy and safety parts of marketing applications both within the centralised and decentralised procedures. Besides medical assessments, Dr. Penninga has a special interest in orphan diseases, and in 2016, entered the Committee for Orphan Medicinal Products (COMP) as an observer, becoming the Danish representative and a full member of COMP from 2017. Within the COMP, Dr. Penninga mainly assesses applications for orphan medicinal product designation.
Antonia Pickup (Click name for full details)
Company: Scinopsis
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Antonia is a Senior Medical Writer working for Scinopsis in the south of France. Having completed a degree in biology, Antonia worked as a project manager and researcher within the UK National Health Service, after which she became a professional grant application writer. Medical writing provided the opportunity to combine skills learnt in both of these environments. Antonia now has seven years’ experience of writing a wide range of regulatory and medical communications documents for clients ranging from some of the largest pharmaceutical companies to charities and independent researchers.
Franziska Pirkl (Click name for full details)
Company: Kantar Health, Clinical Research
Qualifications: PhD
Franziska has worked in the field of protein biochemistry before she decided to become a medical writer at an international Contract Research Organisation in 2001. She has gained considerable experience in preparing study protocols, study reports, CTD clinical summaries and overviews, and publications. Franziska has also been involved in pharmacovigilance writing, managed large medical writing projects and trained medical writers. Her writing projects have covered a wide range of therapeutic areas including cardiology, dermatology, endocrinology, gastroenterology, immunology, musculoskeletal disorders, neurology, oncology, ophthalmology, pulmonary/respiratory diseases, and rheumatology. In 2011, Franziska joined Kantar Health, Clinical & Real World Research, where she now leads the medical writing team.
Tatjana Poplazarova (Click name for full details)
Company: GlaxoSmithKline Biologicals, Belgium
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Tatjana is currently Head of Medical Governance and Bioethics at GSK Biologicals and leads a team of experts promoting industry-leading medical governance and bioethical excellence for GSK. Previously, as Director of Scientific and Public Disclosure at GSK Biologicals, Tatjana was heading an international team with representatives in Asia-Pacific, Europe and the USA which was involved in both Regulatory submissions (writing of protocols, study reports, clinical study summaries) and disclosure activities (both web based disclosure and publications). Tatjana is one of the founders of the disclosure team at GSK Biologicals and spearheads both strategic and operational aspects related to Disclosure of Human Subject Research. Tatjana is also the Biologicals representative at the GSK decision making body on disclosure activities.
Gillian Pritchard (Click name for full details)
Company: Sylexis Limited
Qualifications: MSc, MRCP, MFPM, MBA.
Gillian Pritchard (Director, Sylexis Limited, UK) is a regulatory medical writer specialising in writing clinical evaluation reports and literature reviews for medical devices. She has worked on medical devices for orthopaedic, cardiology, ophthalmology, gynaecology, wound closure, diabetes and weight loss indications. Gillian trained as a physician and has many years’ experience as a research physician in academia and phase I-II contract research; as a clinical project manager of phase III trials with Pfizer GRD; and also with a pharmaceutical and medical devices consultancy. In 2006 Gillian established Sylexis Ltd. to provide regulatory writing services for pharmaceutical and medical device clients. Gillian leads literature review, drug safety (adverse events and laboratory safety) and ICH-GCP workshops for EMWA. She was EMWA Treasurer from 2009 to 2013. Gillian presented on the topic of transferable writing skills at the 6th EMWA Symposium on medical devices and is a member of the Medical Device Special Interest Group (MD SIG).
Alison Rapley (Click name for full details)
Company: Freelance
Qualifications: BSc (Hons), Dip Lib Inf Sci
Alison originally came to medical writing via medical information and, after over 25 years as a medical writer, retired from her position as a senior director of the Medical Writing Group of a large CRO in 2014. She continues to provide freelance training, review and quality control and consultancy services within the medical writing community. During her career she has been involved in writing and reviewing numerous protocols, clinical study reports, pharmacovigilance reports and other regulatory documents, and had significant experience in managing medical writing projects, from small individual projects to large multinational projects. She has a particular interest in process development and operations management. Alison has provided training within the company she worked for, and for external clients, and organisations such as the DIA. She joined EMWA at the beginning of her career as a writer and began presenting EMWA workshops in 1999. She served as President of EMWA from May 2016-17 and is currently serving on EMWA’s Professional Development Committee.
Stefanie Rechtsteiner (Click name for full details)
Company: Boehringer Ingelheim
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Stefanie has worked for 15 years in various fields within the pharmaceutical industry. After several years in biotech and in sales she moved to pharmacovigilance where she specialised in safety writing from 2011 onwards. She has extensive hands-on experience on DSUR, RMP and PBRER writing and currently works as a senior pharmacovigilance writer at Boehringer Ingelheim. Stefanie joined EMWA in 2011 and is a member of the EMWA Finance Committee.
Alistair Reeves (Click name for full details)
Company: Ascribe Medical Writing and Translation
Qualifications: BA (Hons), Editor in the Life Sciences
Alistair became a freelance writer, editor and trainer in 2002 after 25 years in the pharmaceutical industry in different roles in market research, clinical research, drug regulatory affairs, medical translation, medical writing, case report form design, and document management and publishing. He has extensive writing and editing experience in a wide range of clinical areas including endocrinology, oncology, infectious diseases, cardiovascular medicine, transplant surgery, traumatology and veterinary and laboratory medicine. Over the past 25 years, he has presented courses on many aspects of medical writing for commercial training organisations and regularly holds in-house courses for small and large pharmaceutical companies throughout Europe. He has given more than 50 workshops at almost all EMWA events since 1997 and is an Honorary Fellow of EMWA. He has also been a major contributor to ‘The Write Stuff’ and ‘Medical Writing’ with articles on language issues. Alistair served as EMWA Conference Director from 2012 to 2014 and returned to the role of EMWA Freelance Advocate for 2 years while Sam Hamilton concentrated on her (vice-)presidency. He retired as a freelancer and EMWA Workshop Leader in 2017, but still supports EMWA where possible, and edits occasional papers for former regular customers.
Cheryl Roberts (Click name for full details)
Company: BioMarin Pharmaceutical Inc.
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Cheryl is currently the head of the European medical writing group for BioMarin, and specialises in medical writing for serious and life‑threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and continued in positions in medical editing and medical writing in both the pharmaceutical and consultancy industry. She holds a degree in Medical Biology and a Masters in Neuroscience.
Andrea Rossi (Click name for full details)
Company: Fresenius Kabi SwissBioSim GmbH – Senior Manager Medical Writer
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Andrea Rossi has a degree in biology from Florence University. After a brief spell at the University, he started working for the Italian affiliate of Eli Lilly as a clinical research associate. In the years that followed, he was responsible for statistics, health outcomes and medical information. Andrea has been working as medical writer since 2003. He is author of more than 400 disclosures and acknowledged for his contribution in several others. From 2007 to 2009 he was on the coordination board of BIAS (Biometristi Italiani Associati) and has been an EMWA member since 2004. Andrea has acted as a trainer for statistics and medical writing in a number of Italian postgraduate medical schools and has been a speaker at national and international conferences. Andrea served as EMWA President from 2013 to 2014.
Thomas Schindler (Click name for full details)
Company: Boehringer Ingelheim
Qualifications: PhD
Thomas has been a medical writer for some 18 years, and has worked in a CRO, as well as in ‘small pharma’ and ‘big(ger) pharma’. He always had a liking for language and loved science at the same time. He therefore studied both and added a PhD in biology to it. After doing postdoctoral research, he went into publishing as a popular science editor and eventually switched over to medical writing. He has extensive experience in both the marketing and the regulatory side of medical writing including clinical trial reports and submission documents. Currently he is head of the European medical writing group of Boehringer Ingelheim Pharma, Germany.
Sven Schirp (Click name for full details)
Company: Boehringer Ingelheim
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Sven Schirp started his medical writing career in 1997. To date, he has covered a wide range of medical writing services, from biomedical publications and global marketing applications to pharmacovigilance documents. He has held several medical writing positions in academia and the pharmaceutical industry in Germany and the USA. Sven is currently Head of Global Pharmacovilgilance Writing at Boehringer Ingelheim. Sven’s trainer experience includes company internal training sessions as well as presentations at DIA conferences and other conferences on pharmacovigilance topics.
Michael L Schneir (Click name for full details)
Company: Herman Ostrow School of Dentistry of University of Southern California
Qualifications: PhD
Michael, a professor in biochemistry, teaches research writing to graduate students and residents. His current research is to determine distractions of clarity in medical writing by focusing on distraction identification at different textual levels (intra- and inter-sentence) and on their syntactic taxonomic classification. The intent is to transform intuitive copyediting into systematic analysis.
Walther Seiler (Click name for full details)
Company: Bayer HealthCare AG
Qualifications: PhD, Editor in the Life Sciences
After a classical education as a zoologist, Walther Seiler gained his PhD in neuroendocrinology at the University of Mainz, Germany. Throughout his academic career, he enjoyed interpreting and presenting data at least as much as generating them, so medical writing was a logical career step.  After several years of medical writing in an international CRO, Walther moved to a global pharma company, overall gaining 25 years of medical writing experience.  Clinical study protocols (CSPs) soon caught Walther’s interest because they form the basis for many important downstream clinical documents.  For many years, Walther has been involved in the development and maintenance of his company’s CSP template
Satyen Shenoy (Click name for full details)
Company: Describe Scientific Writing & Communications
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Satyen is a medical writer operating his consultancy, Describe, from Germany. Satyen comes from a background in biomedical research having spent over a decade in academia as well as the pharma industry, in India, the USA, and Germany. He has worked on various research projects, ranging from gene-bashing to stem cell differentiation to anticancer drug discovery. In 2010, Satyen got his first taste of medical writing while drafting a manuscript for a large-scale vaccine trial conducted by a multinational pharma company. Since then, he has found his true calling, has traded his labcoat for a Macbook Pro, and pursued a career in medical writing. With an intention of being a part of the medical writing profession in Europe, Satyen moved to Germany in 2015 to open his little scriptorium. Satyen has been an EMWA member since 2010. He is a volunteer with the Freelance Business Group (FBG), as a Freelance Advocate in the past and as Chairperson of the FBG subcommittee since May 2018. Besides promoting effective scientific communication, Satyen is also keenly involved in the development of freelance medical writing as a profession in Germany and Europe
Abraham Fred Shevack (Click name for full details)
Company: Associated Medical Writing Services (AMS)
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Abraham F Shevack MA ELS, is the principal owner of Associated Medical Writing Services (AMS) since May 2016 and has had over 20 years of experience in the pharmaceutical industry. He holds a BA in Biology from the City University of New York and an MA cum laude from Boston University.  He has worked in basic research at the Max Planck Institute for Molecular Genetics and published with leading scientists such as Ada Yonath (winner of the Nobel Prize in chemistry in 2009 for solving the structure of the ribosome). In 1996, his interests in scientific writing and editing led him to start a career as a medical writer first at Schering AG and then from 2006 with Bayer AG. As a global senior scientific medical writer,  he prepared clinical study protocols, study reports, and CTD documents for international regulatory submissions in a wide range of therapeutic indications. Abe is a past-President of EMWA where he has been a member since 1996.
Katja Silberbach (Click name for full details)
Company:
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Katja works in the medical affairs department of MSD Sharp & Dohme GmbH in Germany. She has been Medical Advisor in Anti-Infectives for 8 years and switched to an MSL position in oncology in 2014. She has experience as a medical manager in a CRO as well as a brand manager in a large marketing company. As a medical advisor, she led phase IV clinical and preclinical projects, was involved in health outcomes and economic research studies and served as medical contact for marketing and sales colleagues.
Kari Skinningsrud (Click name for full details)
Company: Limwric as
Qualifications: MS (Chem)
Kari has been a freelance medical writer in Norway since 2002, following ~10 years in clinical research in the industry. She now works mainly with medical communication and training (particularly manuscript writing). She has given workshops on manuscript writing at several universities in different countries, gives EMWA workshops on manuscript writing, grant-writing and cross-cultural communication, and is currently serving on EMWA’s Professional Development Committee.
Kamila Sroka-Saidi (Click name for full details)
Company: Boehringer-ingelheim
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Kamila Sroka-Saidi has a PhD in neurosciences from the University of Göttingen, Germany. Following a couple of years spent working as a postdoctoral researcher at Merz Pharmaceuticals, in 2012 she joined Boehringer Ingelheim Pharma as a medical writer. Most recently, she has been involved in establishing a process for the writing of lay summaries of clinical trial results.
Uma Swaminathan (Click name for full details)
Company: GlaxoSmithKline Biologicals, Belgium
Qualifications: MSc, MBA
Uma’s passion for medical writing brought her all the way from Bangalore (India) to Belgium. During her Scientific Writing career of over 7 years at GSK, Uma has worked on a wide range of regulatory and disclosure documents across different vaccine projects. Following her stint in Medical Writing, Uma headed the Web Disclosure Team in GSK Biologicals which allowed her to further develop her skills in the field of project management, medical governance and scientific communication.  These included such diverse activities as understanding and complying with the complex and ever-changing legal and regulatory requirements for disclosure; planning, tracking and delivery of protocol and results summaries; cross-functional training; and increasing the public disclosure awareness within the company. Uma then set up the Clinical Process Excellence Team in GSK Biologicals with oversight for process and written standards simplification in the human subject research space across all Clinical Delivery functions and transversally for the activities directly impacting clinical trials. In her current role, Uma heads the Clinical Development Policy and Process group in GSK Pharma that drives consistency, accountability and continuous improvement in the way clinical development processes are governed, created, documented and continuously improved.
Wolfgang Thielen (Click name for full details)
Company: CSL Behring GmbH
Qualifications:
During his studies of English and Physics at Johannes Gutenberg University, Mainz, Germany and at Georgia State University in Atlanta, Wolfgang chanced upon a student job that involved planning and writing publications and grant proposals for Mainz Children’s Hospital. Encouraged by these new and very positive experiences in medical/scientific writing, Wolfgang decided to throw his original career plan (high-school teacher) over board and work his way through the ins and outs of regulatory writing. With almost 5 years of medical writing experience in a wide range of regulatory documents and indications, Wolfgang joined CSL Behring in August 2008 where he enjoys working on the company’s global medical writing projects in the exciting fields of bleeding disorder, immune deficiencies, and critical care. Wolfgang’s teaching experience includes the “PIP Show” at past EMWA conferences, as well as unveiling the mysteries of the “awful German language” to pupils at a comprehensive school in England and to engineers and language students at Glasgow University.
Kathy Thomas-Urban (Click name for full details)
Company: Medical & Scientific Writing & Publication Services
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Kathy B Thomas is an independent consultant and medical writer with more than 20 years of experience in the pharmaceutical industry and academia, and extensive knowledge of clinical trial disclosure law in the US and EU. She has worked on preparing registry entries and developing internal guidelines, as well as processes to assure compliance. Previously, Kathy served as Head of Medical Writing at Altana Pharma AG in Konstanz, Germany.
Sarah Tilly (Click name for full details)
Company: Azur Health Science
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Sarah values the people with whom she writes in the same way she values the patients about whom she writes, and the customers for whom she writes. She believes that everyone has their own, unique contribution to give to our industry. For this reason, Sarah has been involved in mentoring new medical writers since an early stage of her career. In parallel with her largely regulatory writing experience, she has managed and mentored several teams of writers and has been involved in setting up and coordinating training systems. At Azur Health Science, she is still actively involved in advising and mentoring other writers. Sarah has been medical writing since 2006 in clinical research organisations and medical writing consultancies. She set up Azur Health Science in 2017 as Medical Writer and Director. She holds a first degree in Biology and a PGCert in International HTA, Pricing and Reimbursement.
Robbert van der Voort (Click name for full details)
Company: Freelance
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Following a career as a (senior) academic scientist and clinical project manager in tumour immunology and haematology, which lasted almost twenty years, Robbert made an exciting switch to freelance medical and scientific writing in 2013. He started his own company, Vision Medical Communications, and has enjoyed working as a freelance writer ever since enormously. As a medical and scientific writer, but also previously in academia, Robbert gained extensive experience in the delivery of (inter-)national meeting reports, interviews, summaries of clinical and scientific articles, manuscripts and (scientific) policy evaluations. His area of expertise includes, but is not limited to, oncology, haematology, nephrology and (clinical) immunology. Robbert has been a member of EMWA since 2013 and became a workshop leader in 2014.
James Visanji (Click name for full details)
Company: Trilogy Writing & Consulting GmbH
Qualifications: PhD MCIL
James is currently manager at Trilogy Writing, based in Frankfurt, where he focuses on clinical and regulatory documentation, in particular submission dossiers in oncology and non-oncological haematology. Previously deputy director of medical writing at Accovion (now Clinipace), he has postdoctoral research experience in oncology and cell biology at the University of Manchester and European Institute of Oncology (Milan), and experience as a translator. James provides training in regulatory writing and medical communications to clients worldwide, has been an EMWA workshop leader since 2012, and EMWA treasurer since 2013.
Tiziana von Bruchhausen (Click name for full details)
Company: Boehringer Ingelheim
Qualifications: PhD
After spending almost 10 years in basic research, in 2008 Tiziana moved to the pharmaceutical field and specialised in pharmacovigilance and medical writing. She worked in a contract research organisation and, later, offered freelance pharmacovigilance and medical writing services to mid-sized and large pharmaceutical companies. She currently works as a Senior Pharmacovigilance Writer at Boehringer Ingelheim Pharma. Since 2012, Tiziana has held pharmacovigilance writing workshops for various institutions and has been highly engaged at the EMWA as a workshop leader and a member of the Pharmacovigilance Special Interest Group (PV SIG) committee. In May 2017, she took over the role of Chair of the PV SIG and was elected Vice President of EMWA.
Thomas Wagner (Click name for full details)
Company: Merck KGaA
Qualifications: PhD
Thomas is a biologist by training and was working hard to unravel the mysteries of the brain using his own brain and such obscure things as glass needles, fluorescent dyes and white powders called neurotransmitters. However, in order to avoid going mad himself, he quit university and started his medical writing career in 1999 with the CRO Kendle in Munich. In 2002 he changed to big pharma and worked for Lilly Deutschland GmbH, mainly writing on Phase III-IV projects, including observational studies. Still working in the area of madness he mostly tackled psychiatry, quality of life, and red tape in the position of Group Leader Scientific Communications Europe for Neurosciences at Eli Lilly & Co. To avoid getting entangled too much he then changed in 2009 to the other side of the fence now working as a service provider and consultant for Trilogy Writing & Consulting as Medical Writing Manager. Finally in 2015 Thomas moved to the headquarters of Merck KGaA in Germany and is responsible for all regulatory medical writing documents from Phase I to post-marketing studies in the “beyond oncology” area.
Andrew Walker (Click name for full details)
Company: Bioscript Regulatory
Qualifications: PhD
Andrew has spent over 20 years working in clinical development.  As a medical writer, he has worked as a freelance writer, for agencies and in-house for AstraZeneca.  Andrew has worked in medical communications as well as a regulatory writer, the latter being his real area of expertise on account of the 15 years spent in the regulatory writing group at AstraZeneca.  During this time, he was involved in the design and delivery of many regulatory submissions, mentoring and training of staff, and the development of many of the processes for delivering high-quality regulatory documents.  In addition to writing, Andrew also spent several years as an Information Director with responsibilities for design and interpretation of clinical programs, notably in the infection therapy area.  Since leaving AstraZeneca, he has joined Bioscript Regulatory and continues to work in the infection area providing expertise and support to clients who are developing novel antibiotics.
Sophie Walker (Click name for full details)
Company: Scinopsis
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Sophie is a medical writer at Scinopsis. Trained in psychology, she worked in academic research for 10 years, with specific interests in neurodevelopment and the impact of stress on brain and behaviour. Sophie has a doctoral degree in neuroscience and published 8 scientific articles during her research career.
Rita Wellens (Click name for full details)
Company: Wellens Clinical Research Consulting
Qualifications: MSc, PhD
Rita has 20-years-plus experience with project management (Phase I-IV), training, and medical writing for pharmaceutical companies and CROs. She managed epidemiology projects worldwide for GlaxoSmithKline Biologicals and specialised in pharmacoepidemiology and pharmacosurveillance at the London School of Hygiene and Tropical Medicine. She held university faculty positions mainly in the USA that included teaching human biology, epidemiology, biostatistics, and research methodology. She was a Fulbright scholar and recipient of several NIH and AHA research grants. She served on the EMWA Professional Development Committee (EPDC) from 2007 to 2010, was elected EMWA Vice-President in May 2010 and continued as President from May 2011 to May 2012. Her involvement as an EMWA workshop leader started in 2001. Rita strongly feels that medical writers play a crucial role in the critical appraisal and sound reporting of medical findings.
Jo Whelan (Click name for full details)
Company: Textpharm Ltd
Qualifications: MSc
Jo has over 20 years’ experience in scientific publishing and medical writing. She specialises in market access, working as a freelance professional through her own company based in the UK. She has written and managed a wide variety of documents for pharmaceutical companies, market access consultancies and medical communications agencies, and also enjoys getting involved in projects as an analyst. In a previous life she has written numerous news and feature articles for the scientific and consumer health press, and is author of four health-related books for teenagers. She has a particular interest in oncology and holds an MSc in Cancer Therapeutics from Barts Cancer Institute, Queen Mary University of London. Jo served as EMWA Education Officer from 2011 to 2014.
Kathryn White (Click name for full details)
Company: Cathean Limited Medical Writing Consultancy
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Kathryn worked as a clinical research manager and medical writer in the pharmaceutical industry for over 15 years, before embarking on a freelance career. Since becoming a freelancer, Kathryn has successfully worked alongside international business coach, Elaine Bailey, to improve her own work-life balance and business processes, systems and practices. Kathryn has experienced first-hand the significant benefits of coaching; the strategies she has implemented have positively impacted her work-life balance and business success. In summer 2012, Kathryn initiated the first UK medical writers’ retreat for freelancers, which was well attended and received very positive feedback. She continues to organise these retreats and has published articles on the concepts of working in and on your business. Kathryn has been a member of EMWA since 2010 and has co-edited the Out On Our Own section of the Medical Writing journal, co-hosted the Freelance Business Forum and supports the EMWA webinar team.
Chris Winchester (Click name for full details)
Company: Oxford PharmaGenesis
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Chris Winchester is a strategic communications specialist and Managing Director of Oxford PharmaGenesis, an independent HealthScience communications consultancy. Chris enjoys developing global medical communication programmes on behalf of pharmaceutical and biotechnology clients, as well as professional societies, patient groups and academia. He has built strong relationships with leading experts in a range of therapeutic areas over the past 15 years. Chris completed a DPhil in Biochemistry at the Medical Research Council Immunochemistry Unit, University of Oxford. He holds an honorary academic position at Durham University, and has served on the European Committee of the International Society for Medical Publication Professionals (2011–2012). Oxford PharmaGenesis received a Queen’s Award for Enterprise in 2015 for outstanding achievement in international trade, and won a Communiqué Award for Excellence in Corporate Social Responsibility in 2016.