Introduction Workshop programmes at EMWA conferences Booking workshops Foundation and advanced workshops Gaining EPDP credits Pre-workshop assignment The workshop Post-workshop assignment Sending your assignments Credit records EMWA certificates Foundation certificates Advanced certificates Repeating workshops Fees for certificates Workshops currently in the EPDP programme
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EMWA Professional Development Programme Brochure

(Last Updated: February 2019)

Introduction

The EMWA Professional Development Programme (EPDP) provides high-quality training for medical writers through workshops and homework assignments. We run the workshops at our twice-yearly EMWA conferences.

All EPDP workshops are approved by the EMWA Professional Development Committee (EPDC) and are given by people with extensive professional experience in the topic. Most are a mixture of lectures and group exercises, with time for questions and discussion.

EMWA workshops usually have a pre-workshop assignment and all have an assessed post-workshop assignment. If you attend EPDP workshops and successfully complete the assignments you can gain EPDP credits, which can allow you to apply for an EMWA certificate. The element of assessment ensures that EMWA credits represent a real attainment, and are a valuable addition to your CV. Credits are added to your personal EMWA professional development record, which you can view online in your EMWA account as long as you remain an EMWA member.

EMWA credits and certificates demonstrate your commitment to continued professional development. However, an EMWA certificate is not an endorsement by EMWA of a person’s professional competence – that is, EMWA has not ‘certified’ the certificate holder. Holding an EMWA certificate does not entitle you to claim that you are ‘EMWA certified’ or a ‘certified medical writer’ or similar statement.

Workshop programmes at EMWA conferences

EPDP workshops are only available at EMWA’s twice-yearly conferences. As well as the workshop programme, our conferences offer other opportunities for professional development including seminars, plenary sessions, and symposiums. See the conference pages for information about past and upcoming conferences.

Because we have such a wide variety of workshops, we are unable to run all of them at every conference. When we are scheduling workshops for a conference, we try to ensure the programme covers a broad range of topics and offers a balance of foundation and advanced workshops. We also take account of demand for topics at previous conferences.

Workshops are open only to EMWA conference attendees. Conference registration for non-members includes 1 year’s membership of EMWA.

Booking workshops

There is a fee for each workshop, in addition to the conference registration fee (see conference details on the EMWA website).

Workshop places are allocated on a first-come-first-served basis. Some workshops fill up quickly, so it is advisable to register early to avoid disappointment. Booking early will also give you the benefit of the early-bird discount on registering for the conference.

To gain maximum benefit from the conference programme, we recommend you register for a maximum of 4 EPDP credit workshops per conference.

Foundation and advanced workshops

Foundation level workshops are aimed at those who are new to a topic, or who have a moderate level of experience in it. They have a maximum 32 participants and last 3 or 3.5 hours.

Advanced level workshops cover topics that are likely to be of interest to more experienced writers, or deal with foundation level topics in greater depth. There are no formal prerequisites to participate, but leaders will not be able to spend time explaining the basics of the topic to inexperienced participants. The participant profile in the individual workshop description gives details of experience required. Advanced workshops have a maximum of 20 participants and always last 3.5 hours. Some advanced workshops are designated as ‘master classes’. These are highly interactive workshops with a maximum of 12 participants.

There are a few all-day workshops in the programme.

Gaining EPDP credits

Both foundation and advanced workshops can be done to gain EPDP credits. To gain a credit, you must do the pre-workshop assignment (if applicable), attend the workshop, and satisfactorily complete the post-workshop assignment, as described below. If you satisfactorily complete an all-day workshop, you will be awarded 2 credits.

Pre-workshop assignment

After registering for the conference, download the pre-workshop assignment from the EMWA website, complete it (this usually takes up to 2 hours), and submit it to the workshop leader by the deadline given, if applicable. A small number of for-credit workshops do not have a pre-workshop assignment.

If you register for the conference after the deadline for the pre-workshop assignment, you should submit the assignment as soon as you can if you wish to obtain credit. Pre-workshop assignments must be submitted before the workshop. They cannot be accepted after the workshop.

The workshop

To receive credit you must attend the workshop. Participants who miss more than 30 minutes of instructional time (by arriving late, leaving early or leaving the room for a long period) will not be eligible for credit.

Post-workshop assignment

The workshop leader will give you the post-workshop assignment at the end of the workshop or send it to you afterwards.

You must complete the post-workshop assignment to a satisfactory standard, and submit it by the deadline given. It usually takes up to 3 hours to complete a post-workshop assignment, and the deadline is usually about 6 weeks after the conference.

The workshop leader will mark the assignment, let you know whether you have gained a credit, and send you feedback (for example, a model answer or individual comments).

Please note that post-workshop assignments must be your own work. We do not accept joint submissions or submissions based on joint working unless specified by the workshop leader.

Sending your assignments

It is your responsibility to ensure that your assignment reaches the workshop leader. Leaders are asked to acknowledge receipt; if you don’t receive an acknowledgement within a week, you should contact the leader again to check they have received your assignment. Please follow any special instructions for sending the assignment – for example, a specified email address or email subject line.

Credit records

Credits from each conference are collated by EMWA Head Office and uploaded to members’ individual accounts, where they will appear approximately 12 weeks after the conference.

EMWA certificates

You can apply for an EMWA certificate by collecting EPDP credits. You need 8 credits from different workshops to qualify for a certificate. Each EPDP credit can only count once towards 1 certificate. Contact EMWA Head Office to apply for a certificate: email info@emwa.org.

EPDP for-credit workshops are divided into 6 areas of expertise: Drug Development, Language and Writing, Medical Communication, Medical Devices, Medical Science and Professional Techniques.

EMWA certificates are certificates of achievement in continuing professional development. They are not an endorsement by EMWA of a person’s professional competence – that is, EMWA has not ‘certified’ the certificate holder. Holding an EMWA certificate does not entitle you to claim that you are ‘EMWA certified’ or a ‘certified medical writer’ or similar statement. Appropriate wording would be: 'I have a foundation [an advanced] certificate from the EMWA professional development programme.

Foundation certificates

An EMWA foundation certificate is awarded for 8 credits from foundation workshops as follows:

You may obtain more than 1 foundation certificate after completing the appropriate requirements for each certificate. Certificates list the workshops for which credits have been obtained.

Advanced certificates

An EMWA advanced certificate is awarded for credits in any 8 different advanced workshops (these include master classes run for credit). You do not need to have a foundation certificate to register for advanced workshops.

You may obtain more than 1 advanced certificate after completing the appropriate requirements for each certificate. Certificates list the workshops for which credits have been obtained.

Repeating workshops

If you are awarded a credit for a workshop and then repeat the same workshop within 5 years, you will not get another credit. The only circumstances in which this will not apply will be if the workshop leader has updated the workshop to the extent that a new outline and abstract have been submitted to the EPDC. In this case, credit will be awarded for the updated workshop.

‘Repeating a workshop’ will be defined by the core code for the workshop and not by the additions that indicate a minor variation, such as change in workshop leader or workshop title. For example, DDA10 and DDA10a would count as the same workshop.

We cannot accept workshop credits awarded before November 2009 in applications for certificates, because of the way records were kept historically.

EMWA certificates are certificates of achievement in continuing professional development. They are not an endorsement by EMWA of a person’s professional competence – that is, EMWA has not ‘certified’ the certificate holder. Holding an EMWA certificate does not entitle you to claim that you are ‘EMWA certified’ or a ‘certified medical writer’ or similar statement. Appropriate wording would be: 'I have a foundation [an advanced] certificate from the EMWA professional development programme.

Fees for certificates

An administration fee (currently €100.00) will be charged for issuing certificates. This charge reflects the considerable cost of administering members’ training records. The certificate fee replaces the programme enrolment fee that was previously charged.

Workshops currently in the EPDP programme

Currently active workshops are listed below. Click on the workshop title for full details.

You can also browse the workshop leaders’ biographies.

The codes in the workshop list tell you which area of expertise the workshop covers and whether it is a foundation or advanced level workshop.

Area of expertise covered by the for-credit workshop Foundation Advanced
Drug Development DDF DDA
Language and Writing LWF LWA
Medical Communications MCF MCA
Medical Science MSF MSA
Professional Techniques PTF PTA
Medical Devices MDF MDA

There are also some Soft Skills workshops that are not for credit.

Some topics are covered from different perspectives by different workshop leaders. If you are not sure how to choose between similar workshops, read the workshop abstracts.

Not all workshops are available at all conferences. For further information please refer to the specific conference brochure on the EMWA website.

 
Medical writers with a working knowledge of clinical drug development and some insight into CMC and nonclinical development. Experience writing IBs or IMPDs would be relevant.
 
 
This workshop is aimed at medical writers with some experience of assessing drug safety information, and a basic understanding of the overall drug regulatory environment. It will also be useful to writers who are familiar with previous PSUR requirements detailed in Volume 9A but have little or no experience of the new requirements in line with GVP Module VII and the revised ICH E2C. For writers with no previous experience of pharmacovigilance documents it is recommended that they attend the foundation workshop “Introduction to Pharmacovigilance Writing” before attending this workshop.
 
 
This workshop is aimed at medical writers with some experience of assessing drug safety information, and a basic understanding of the overall drug regulatory environment. It will also be useful to writers who are familiar with previous PSUR requirements detailed in Volume 9A but have little or no experience of the new requirements in line with GVP Module VII and the revised ICH E2C. For writers with no previous experience of pharmacovigilance documents it is recommended that they attend the foundation workshop “Introduction to Pharmacovigilance Writing” before attending this workshop.
 
 
This workshop is for medical writers who would like to learn more about writing the documents needed for clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies). Participants should have basic knowledge of healthy volunteer study objectives and design (participants who do not have this knowledge should first take Workshop DDF39 An Overview of Healthy Volunteer Studies) and some experience in writing key clinical trial documents (informed consent forms, protocols, clinical study reports).
 
 
Participants should be familiar with the drug development process and have an understanding of basic pharmacokinetics.
 
 
The course is intended for medical writers with little or no experience of writing clinical submission dossiers although participants should be familiar with the clinical development process and have had some experience of writing clinical study reports.
 
 
Aimed at medical writers with some experience of writing risk management plans (RMPs) or other safety documents (e.g. Periodic Safety Update Reports), or who have attended the foundation workshop on RMPs (the latter may be helpful for those with no experience of RMPs). Participants may also find the workshop “Introduction to Pharmacovigilance writing” (DDF32) helpful.
 
 
This workshop is appropriate for regulatory/medical communicators who are moderately experienced in writing clinical regulatory documents.
 
 
This workshop is intended for medical writers who have already some experience in the writing of clinical study reports (CSRs) but no experience in oncology. Participants should have a general understanding of clinical study designs, of the guidance provided by ICH E3, and should be familiar with statistics, in particular with time-to-event analysis.
 
 
Medical writers who would like to gain advanced knowledge about RMP and PSUR assessment processes and the role of the medical writer after document submission in Europe. Participants without hands-on experience with RMPs and PSURs should in advance attend the courses DDA14a, DDF30, or DDF32.
 
 
Participants should be familiar with the drug development process and have an understanding of basic pharmacokinetics and statistics. In addition, participants should have experience with clinical study reports and regulatory submission dossiers.
 
 
The Investigational Medicinal Product Dossier (IMPD) is an important part of the clinical trial application (CTA) which is submitted to the EMA for approval of clinical trials of investigational medicinal products (IMPs) in the EU. Those who stand to benefit from this workshop are regulatory personnel and medical writers in the pharmaceutical industry, CROs, and medical writing agencies who are involved in preparing regulatory documentation – especially documents pertaining to the chemistry, manufacturing, and quality control (CMC) of IMPs. Participants of this workshop will be expected to have experience/knowledge of the drug development and approval process, especially in the US and the EU as well as familiarity with various components of the eCTD.
 
 
This workshop addresses writers dealing with or interested in documents for non-interventional (observational) studies for epidemiology, real life safety and efficacy, health economics, and quality of life. This is a development of the DDA 9 workshop with an emphasis on the new opportunities to design studies using existing clinical databases. Participants should have at least 2 years of medical writing experience with study related documents (e.g. protocol, CSR, scientific publication).
 
 
Medical writers with knowledge of MAA or NDA preparation who are interested in expanding their knowledge of authority review processes and the role of medical writing after dossier submission in Europe and the US.
 
 
This workshop is aimed at writers with experience in writing clinical study reports but who are new to writing CTD Clinical Summaries.
 
This workshop will benefit medical writers who have an interest in the clinical development of orphan medicinal products, and who are familiar with the European Medicines Agency marketing authorisation application (MAA) procedures. Prior attendance to DDF13 Basic Concepts of Study Design in Clinical Development would be helpful but is not essential.
 
 
This workshop is for medical writers who would like to obtain knowledge about the Development Safety Update Report (DSUR). Participants should have some experience of collection and analysis of safety data, and an understanding of safety monitoring during clinical trials. Participants without this knowledge or without experience in safety/pharmacovigilance writing should in advance attend the course DDF32.
 
This workshop is aimed at medical writers who would like to obtain knowledge about the Development Safety Update Report (DSUR). Participants should have some experience of collection and analysis of safety data, and an understanding of safety monitoring during clinical trials. Participants without this knowledge or without experience in safety/pharmacovigilance writing should in advance attend the course DDF32.
 
 
This workshop is aimed at writers with experience in writing study reports but who are new to writing Clinical Overviews for the Common Technical Document (CTD).
 
 
This workshop will be of most value to those who already have some experience in clinical development and have become familiar with different kinds of clinical trial. Terms such as crossover, double dummy, baseline, endpoint, active control, intent to treat, per protocol, and surrogate endpoints will be used extensively but will not be explained. The content is not immediately sequential to the content of the beginner's workshop on Basic Study Design. You should have a minimum of 2 years of clinical development experience or at least a sound science background to obtain maximum benefit from this workshop.
 
 
This workshop is intended for medical writers who wish to learn more about the global regulatory environment for pharmaceuticals.
 
 
This workshop is intended for medical writers who are familiar with the clinical development process but have no or limited experience in writing subject narratives for clinical study reports.
 
 
The workshop is intended for medical writers with little or no experience of writing clinical study protocols (CSPs), although basic knowledge of the clinical development process is expected.
 
 
This workshop is aimed at writers who wish to learn about the concepts underlying clinical development (e.g. the standard sections of a study protocol aimed at proving efficacy or the literature on clinical trials of efficacy). The workshop is suitable for those setting out to write regulatory documents as well as those who already have experience in medical communications or medical publishing who wish to understand the concepts underlying experimental study design.
 
 
This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial ethics will be provided for interactive discussion.
 
 
Medical writers working in clinical research organisations or the pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers following, reviewing and revising existing Standard Operating Procedures (SOPs), or creating new SOPs. This is an ideal forum for writers whose organisations or clients have scope to improve their SOPs.
 
 
This workshop is intended for writers with little Good Clinical Practice (GCP) experience whose work involves clinical trial documents e.g. informed consent forms, protocols and reports.
 
 
This workshop is intended for writers with little Good Clinical Practice (GCP) experience whose work involves clinical trial documents e.g. informed consent forms, protocols and reports.
 
 
This workshop is intended for people who are new to medical writing and who are involved in writing the safety sections of clinical study reports or related safety summaries.
 
 
This workshop is intended for people who are new to medical writing and who are involved in writing the safety sections of clinical study reports or related safety summaries.
 
 
This workshop is intended for people who are new to medical writing and who are involved in writing the safety sections of clinical study reports or related safety summaries.
 
 
This workshop is intended for medical writers who are new to writing the safety sections of clinical study reports or related safety summaries.
 
 
This workshop is intended for medical writers who are new to writing the safety sections of clinical study reports or related safety summaries.
 
 
This workshop is designed for people who are new to medical writing in general, and those who are new to regulatory writing.
 
 
The workshop is intended for medical writers with little or no experience of writing protocol amendments, although basic knowledge of the clinical development process is expected. Moreover, it is recommended that participants had already taken Workshop DDF12 (Content and structure of clinical study protocols; version 2014) although this is not a must. Note: Until 2013 inclusive, the topic of protocol amendments had been part of Workshop DDF12. Therefore, anyone having taken DDF12 in 2013 or earlier is unlikely to fully benefit from Workshop DDF29.
 
 
Medical writers with at least 1 year of experience in the pharmaceutical industry.
 
 
Aimed at medical writers with little or no experience of writing risk management plans (RMPs), but with a basic knowledge of the overall drug development process and some experience in assessing and presenting non-clinical and clinical data on drug safety and risks. Ideally, participants with no knowledge in pharmacovigilance should attend the foundation workshop on pharmacovigilance writing (DDF32) prior to register to this workshop. Writers with more experience of RMPs should consider EMWA’s advanced workshop on the topic, DDA20.
 
 
Writers who want to better understand the different types of pharmacovigilance (PV) documents, when and why they are needed and how they interact with each other. It is recommended that this workshop is completed before attending the advanced workshops for writing Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).
 
 
Writers who want to better understand the different types of pharmacovigilance (PV) documents, when and why they are needed and how they interact with each other. It is recommended that this workshop is completed before attending the advanced workshops for writing Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).
 
 
Writers who want to better understand the different types of pharmacovigilance (PV) documents, when and why they are needed and how they interact with each other. It is recommended that this workshop is completed before attending the advanced workshops for writing Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).
 
 
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).
 
 
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).
 
 
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).
 
 
This workshop is aimed at medical writers with little or no experience of writing about efficacy in clinical and regulatory documents. Basic knowledge of the clinical development process is expected.
 
 
This basic workshop is intended for participants directly or indirectly involved in the planning, analysis and/or reporting of clinical trials, or in the design of clinical development programs, or those with little or no background in this area who are interested in learning the basics. Previous experience or background knowledge of clinical trial disclosure is not required. This workshop will benefit newcomers to the topic, but also those simply wishing to update their knowledge of this topic.
 
 
This workshop is for medical writers at different stages of their career. There is no prerequisite in order to participate but a basic knowledge of clinical trial documents is expected.
 
 
Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. There are no prerequisite EMWA workshops for attendance at this workshop.
 
 
Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of International Council for Harmonisation (ICH) reporting guidelines.
 
 
Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of ICH reporting guidelines.
 
 
Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of ICH reporting guidelines.
 
 
This workshop is for medical writers who would like to gain insight into the unique aspects of clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies).
 
 
This workshop is aimed at all medical writers, including native English speakers, who would like to develop their skills and awareness when writing information for patients.
 
 
This workshop is aimed at new medical writers and experienced writers who are new to writing clinical study protocols. Other relevant workshops are “The Clinical Study Protocol: Content and Structure”, “Basic Concepts of Study Design in Clinical Development” and “Managing the Clinical Study Protocol Writing Process”.
 
 
This workshop is intended for writers who have basic experience in regulatory medical writing (RMW) and an interest in document consistency and project management. Writers without previous RMW experience could also benefit from this workshop after completing one additional pre‑workshop requirement.
 
 
This workshop is intended for participants wishing to learn about the requirements, timings, and processes for disclosure of clinical trial results in public databases in the US (ClinicalTrials.gov) and EU (EudraCT). Understanding basic clinical development stages and knowledge of regulatory documents (clinical study protocol, clinical study report, and statistical analysis plan) are essential. Previous experience in clinical trial results disclosure is not required.
 
 
Medical writers working in the clinical research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers tasked with preparing or performing quality control checks on appendices for clinical study reports (CSRs). This is an ideal forum for writers whose organisations or clients provide little guidance on appendix requirements, beyond provision of ‘ICH Guideline E3: Structure and content of clinical study reports’ and, further, may facilitate improvement in existing analysis and reporting processes and procedures.
 
This introductory workshop is designed for participants with little or no experience of the drug development process or the regulatory documents required.
 
This workshop is aimed at medical writers, both new and experienced, who would like to improve their understanding of veterinary regulatory affairs. This is a foundation level workshop. No previous knowledge of veterinary regulatory affairs is assumed, but experience in the Market Authorisation of pharmaceuticals would be helpful. This workshop is expected to be of benefit for personnel working in Regulatory Affairs, Research and Development, Clinical Trials and Marketing.
 
 
This workshop is designed for medical writers who are new in the field of regulatory writing and clinical development. The workshop will provide an overview of the conduct of a clinical trial. Although the workshop does not go into detail about each of the topics addressed, it will serve as a basis for more specialised workshops.
 
 
This workshop is aimed at medical writers, both new and experienced, who need to understand the basics of pharmacokinetics. Participants will normally have had little if any previous formal instruction in pharmacokinetics, or may not have understood what instruction they have received (or may even have received such instruction before they realised they would need it).
 
 
This workshop is targeted towards medical writers whose native language is not English. Native speakers who encounter difficulties with the use of adverbs, or need to be aware of the difficulties experienced by non-native English writers in this area, are also welcome. Note: The content of this workshop partly overlaps with the "Adverbs" part of what was previously offered as the "Adverbs and Tense" workshop (LWA1). In response to requests from many participants to have more time for exercises, the practical part of the workshop has been expanded. We will also provide more detail on typical problem areas in the use of adverbs in the medical writing context.
 
 
This workshop is targeted towards medical writers whose native language is not English. Native speakers who encounter difficulties with the use of tense or who need to be aware of the difficulties experienced by non-native English writers in this area are also welcome. Note: The content of this workshop partly overlaps with the "Tense" part of what was previously offered as the "Adverbs and Tense" (LWA1) workshop. In response to requests from many participants to have more time for exercises, the practical part of the workshop has been expanded to more than half of the workshop.
 
 
Experienced medical writers.
 
 
This workshop, at an advanced level, is accessible to all medical writers interested in the journal article and syntactic clarity.
 
 
Experienced medical writers or editors who are ready to move into a more senior role. Participants should be competent in editing for style and formatting and in basic language editing.
 
 
This workshop is intended for all medical writers, both native English speakers and those for whom English is a second language, who edit the work of authors who are not native speakers of English. The workshop will be of interest both to those who edit occasionally for colleagues as well as people who edit extensively.
 
 
This course should benefit experienced medical writers to enhance their detection, analysis, and revision of semantically distracting sentences. This enhancement will be facilitated by receiving (from the workshop leader) a taxonomic profile of distractions to a submitted sample of original or copyedited medical writing and by receiving oral feedback from the other participants.
 
 
Medical communicators who want to broaden their awareness of potential communication errors resulting from different linguistic and cultural backgrounds. In contrast to workshop PTF8 "Cross-Cultural Communication", which offers in-depth insight into cross-cultural working environments, this workshop will focus on cultural aspects that influence our medical writing and understanding.
 
 
This course should benefit experienced medical writers to enhance their detection, analysis, and revision of syntactically distracting sentences. This enhancement will be facilitated by receiving (from the workshop leader) a taxonomic profile of distractions to a submitted sample of original or copyedited medical writing and by receiving oral feedback from the other participants.
 
 
Note this is a double workshop – Part 1 is on Thursday 13 May and Part 2 is on Friday 14 May. You must register for both parts. The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues. It is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required.
 
 
This workshop is for medical writers interested in exploring the use of readability tools to help them produce more readable biomedical research text. Participants should have some experience of writing and editing scientific research texts, but do not need specialised knowledge.
 
This workshop is for both native and non-native speakers of English who would like to write more clearly in English. Participants should have some experience of writing about scientific or medical topics.
 
 
This workshop is primarily intended for medical writers whose native language is not English. Native speakers who encounter difficulties or need to be aware of the difficulties experienced by non-native English writers are also welcome. Participants should be prepared to contribute to group discussions and talk about the content of their pre-workshop assignment.
 
 
This workshop will be useful for anyone who wants to make their writing more effective. It will be particularly useful for those who have come into medical writing without receiving any training in writing skills.
 
 
This workshop is intended for medical writers who work mostly on regulatory documents. Participants should have a basic knowledge of the most common regulatory documents (e.g. clinical study reports, protocols, and investigator’s brochures).
 
 
This workshop is aimed at writers who are interested in the influence of product marketing on the need for ethical, but product-friendly publications. It is particularly useful for writers who prepare publications that are driven by a publication plan.
 
 
The workshop was developed for medical writers with little or no experience in preparing systematic literature reviews of clinical studies. Participants should have a good understanding of study design in clinical research as well as of analysis and presentation of data from clinical studies.
 
 
Participants should have some experience with writing scientific papers. The workshop is relevant for those who write or edit papers for others, and for those who wish to improve their own ones.
 
 
This workshop would suit medical writers who have had experience of preparing different types of regulatory documents, and who may be involved in producing documents for patients or other lay audiences. It would also benefit writers involved in medical communications who may be asked to produce written information aimed specifically at non-specialist audiences.
 
 
This workshop is intended for writers or editors who already work on different aspects of company-sponsored symposia, such as slide preparation, or those who might wish to get involved with their organisation in the future.
 
 
This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation. Participants should already have an understanding of CSR structure (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics).
 
 
Anyone who wants to learn more about value messages and writing value dossiers, whether they are new to these topics or have some experience with them. The workshop will not assume any prior knowledge of value dossiers or market access, but will assume a basic familiarity with drug development and clinical data.
 
 
Previous title: Writing Successful Manuscripts This workshop is intended for medical writers who have little or no experience in writing peer-reviewed manuscripts. No prior experience in manuscript writing is necessary.
 
 
This workshop will benefit any medical writer who would like to acquire the basic tools and develop the skills needed to tailor their writing to their objectives, as well as to specific audiences, from children to opinion leaders.
 
 
Medical writers who either have experience in regulatory writing and wish to explore other aspects of medical writing or have done some conference reporting and wish to improve their skills in this area. Communications writers who have little or no experience of conference reporting.
 
 
Researchers who wish to improve the likelihood of getting funds by increasing the quality of their grant applications, and medical writers who would like to assist researchers in writing and improving such applications.
 
 
Understanding the nature of translation processes can be essential to successful globalization of a product. The workshop will be most useful to help identify and to recommend development strategies and techniques that can accelerate projects, improve quality, and lower translation costs. Although the workshop is aimed primarily at managers (including marketing, clinical trials and product managers), bilingual medical communicators will gain insight into good practices and will understand project milestones, allowing them to diversify their activities into a wider environment.
 
 
This workshop is intended for all medical and scientific writers who are involved with the preparation of medical publications
 
 
As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops on scientific journals or congresses publishing.
 
 
This workshop is primarily intended for medical writers who write publications, posters, or conference presentations and who want to improve their abstract writing skills. Medical writers who write summaries that must fit strict format and word limits can also benefit from this workshop. Participants should have some experience writing manuscripts, posters, or conference presentations.
 
 
This workshop is primarily intended for medical writers who write publications, posters, or conference presentations and who want to improve their abstract writing skills. Medical writers who write summaries that must fit strict format and word limits can also benefit from this workshop. Participants should have some experience writing manuscripts, posters, or conference presentations.
 
 
This workshop is intended for medical and scientific writers who are interested in developing clinical and peer-reviewed documents in the specific area of vaccines. Pre-attendance at the Introduction to Vaccines workshop (MSF-10) would be beneficial but is not essential.
 
 
This workshop is intended for medical writers who have little or no experience in writing peer-reviewed manuscripts. No prior experience in manuscript writing is necessary.
 
 
This workshop is aimed at translators willing to expand their knowledge of translations, medical writers diving into translations and in need to build an efficient pool of resources and managers of translation projects requiring a solid foundation to successfully manage their multilingual projects. Prior attendance to Management of Translation Projects (MCF 13) is not required but desirable.
 
 
• Medical writers that have worked primarily on the regulatory side with a desire to expand into promotional medical writing • Medical writers starting out in a healthcare communications and/or advertising agency
 
 
This workshop is suitable for participants looking to improve their skills in the development of medical communication materials for scientific oral presentations. Previous experience in this area is not required; participants will benefit from this workshop whether they are already working in medical communications and would like to improve their skills, or are looking to move into this area.
 
 
Medical writers working in the pharmaceutical, biotech, healthcare or other related industries who would like to know more about the best practices for medical congress coverage. There are no prerequisites for the workshop.
 
 
Medical writers and other professionals working in pharmaceutical, medical devices or communication agency environments who want to know more about the processes involved in developing a communication strategy for a brand.
 
 
This workshop is aimed at writers who already write posters, and would like to make their posters more interesting or those individuals who want to learn how to approach poster writing.
 
 
This workshop will benefit medical writers who want to know more about publishing articles in biomedical journals or who have encountered issues with journals.
 
 
This workshop is aimed at writers who are interested in publication planning. It is particularly useful for writers who are asked to make journal and meeting recommendations for manuscripts.
 
 
 
 
Anyone who wants to develop their fundamental writing skills by building on the philosophy of writing and the writer’s role in expressing an idea in many ways. Anyone interested in gaining some practical insight into areas of writing (from public relations to regulatory) they may not encounter on a daily basis.
 
 
Medical writers who write or expect to write manuscripts based on Clinical Study Reports (CSRs). Participants ideally should have already attended the EMWA workshops on ‘Writing a Clinical Study Report Using ICH E3’ and ‘Writing a Manuscript for Publication’, or should have equivalent experience in at least one of these areas of medical writing.
 
 
This workshop is aimed at, but not limited to, any medical writer working on manuscripts based on clinical study data. This is a foundation course aimed at gaining a basic understanding of how to effectively develop manuscripts based on trials (RCTs are used as the example throughout) using the CSR as the main data source.
 
 
MD-SIG meeting – please join us to get informed about the latest activities
 
 
This workshop is intended for medical writers who are either interested in working with medical devices or who already work with medical devices and are involved in preparing literature reviews for clinical evaluation reports (CERs). Familiarity with European medical device regulations and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.
 
Medical writers with experience in regulatory writing for medicinal products or medical devices. Participants should have attended the workshop ‘Introduction to Writing for Medical Devices’ or should have a basic knowledge of the market approval process for medical devices.
 
 
This workshop is intended for medical writers with regulatory writing experience who are either interested in working with medical devices or who already work with medical devices and are involved in preparing clinical evaluation reports (CERs). Familiarity with the medical device regulation (MDR) 2017/745 and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices or From Pharma to Medical Devices workshops would be helpful but is not essential.
 
 
Medical writers with experience in medical communications or regulatory writing. Some experience and understanding of the regulatory requirements for the market approval of medicinal products is expected.
 
 
This workshop is primarily intended for medical writers who have some knowledge of regulatory guidance and are interested in working with medical devices. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.
 
 
This workshop is primarily intended for medical writers who have some knowledge of regulatory guidance and are interested in working with medical devices. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.
 
 
This foundation workshop is for those who: · have never written a clinical investigation plan (CIP, synonym clinical study protocol) for medical devices · are coming from pharma, or · already have some experience in writing CIPs and want to gain a more profound understanding of this document. No attendance at a previous workshop is required. However, participants would benefit from having previously attended 'Basics of Writing for Medical Devices under the MEDDEV rev. 4 and new Medical Devices Regulations' (MDF1).
 
This course is intended for medical writers with little or no experience in regulatory writing, including Post-market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports, under the Medical Devices Regulation 2017/745 (EU MDR). There is no prerequisite to attend this workshop but basic knowledge of clinical research and medical device terminologies will be useful.
 
 
Experienced writers with basic knowledge of descriptive statistics. Participants are strongly recommended to take the “Basics of Epidemiology for Medical Communicators” workshop before enrolling in the advanced workshop.
 
 
You will normally either have: • Had no formal instruction in pharmacology • Undertaken formal instruction in pharmacology in the past but wish to update your knowledge
 
 
This workshop is intended for anyone who is interested in learning more about vaccines.
 
 
Writers with little or no experience of the clinical development of antibiotics.
 
 
Any regulatory medical writer looking to understand the basics of cell signalling and how it can be used for modern drug development. Ideally, participants will have taken workshops MSF9 (The Fundamentals of Genetics for Medical Writers) and MSF1 (Pharmacology for Medical Writers: the Basics) or have an equivalent knowledge, but the basic concepts required are included in the pre-workshop assignment as a reminder.
 
 
This workshop is intended for scientific/medical writers with little or no background in virology, or those interested in refreshing or updating their knowledge on the fundamentals of the subject. It is particularly relevant for writers working in such areas as infectious diseases, vaccines, and immunology. Participants should already have a basic understanding of molecular biology (DNA - RNA - protein).
 
 
You will normally either have: • Had no formal instruction in pharmacology. • Undertaken formal instruction in pharmacology in the past but wish to update your knowledge. Note: if you have no knowledge of pharmacology, you should not take this workshop until you have taken the workshop ‘Pharmacology for Medical Writers, Part 1: The Basics’.
 
 
Medical writers with basic knowledge of descriptive statistics who want to gain insight into the usefulness of epidemiological principles for medical writing.
 
 
This workshop is aimed at medical writers with little or no understanding of the basics of pharmacogenomics and its applications in drug development, and those who may be working on projects that include pharmacogenomic substudies. A basic knowledge of genetics is essential, however, the three main principles of genetic theory (replication, transcription and translation) will be reviewed.
 
 
Participants should, ideally, have already completed Introduction to Pharmacokinetics (DDF7) and Pharmacology for Medical Writers: Part 1 – The Basics (MSF1), or have equivalent experience or knowledge.
 
 
This workshop is intended for medical writers with little or no background in immunology or those who are interested in refreshing their knowledge on the basic principles of immunology
 
 
This workshop will give a basic understanding of genetic principles to any writer who may need to understand or write about pharmacogenetics or genomics, or with an interest or curiosity in the field. It will also be useful revision for anyone who has not been involved in the area for some time. No prior knowledge is necessary. Participants may find this a useful preparatory workshop for MSF4, Pharmacogenomics, at future conferences.
 
 
This workshop will give a basic understanding of genetic principles to any writer who may need to understand or write about pharmacogenetics or genomics, or with an interest or curiosity in the field. It will also be useful revision for anyone who has not been involved in the area for some time. No prior knowledge is necessary. Participants may find this a useful preparatory workshop for MSF4, Pharmacogenomics, at future conferences.
 
 
This workshop addresses writers dealing with or interested in areas of clinical research, such as psychiatry, pain, quality of life, or health outcomes, where “soft” endpoints are often used to assess treatments. Participants should have at least 1 year of medical writing experience and should already have written a study report or a manuscript based on the results of clinical studies.
 
 
This workshop is suggested for experienced medical writers, particularly those who are in a supervisory role, or who will soon be taking on that responsibility.
 
 
Anyone who wants to explore effective and diplomatic ways of overcoming common interpersonal hurdles that arise in the course of every day life as a medical writer.
 
 
Participants who already mentor other writers or those who may soon be given the role will benefit from this workshop, including those who take on the role voluntarily and those who are more hesitant about their abilities. Most participants will have been medical writing for at least 2-3 years and will have a good foundation in their chosen career path. Complementary workshops: PTA11 – Strategies for Improving Document Quality and PTA12 – Interpersonal Skills for Medical Writers.
 
 
Managers of writing teams (in-house or freelance), experienced writers looking for a career path into management, freelancers working working in networks or in a team, and those who are interested in building network-teams. The workshop mainly focuses and draws examples from regulatory writing teams. Complementary workshops: PTF8–Cross-cultural communication, PTA11–Strategies for Improving Document Quality, PTA12–Interpersonal Skills for Medical Writers, PTA13–The Art of Mentoring.
 
Regulatory medical writers involved in coordinating document review as well as those interested in establishing and improving best document review practices with their clinical teams or their organisations. Familiarity with the general principles of clinical development and regulatory documents (including clinical CTD modules, e.g. Module 2.7 Clinical Summaries and Module 2.5 Clinical Overviews) is assumed.
 
This workshop is suitable for medical writers who have some experience in delivering oral presentations and want to reflect on or improve their oral presentation skills. Participants should find the workshop useful for a variety of situations: presentations to colleagues, pitching to potential clients for new business, training colleagues, or speaking at meetings. Participants should be confident communicating in English, particularly as they will deliver a short presentation in English. (We do not cover slide design and construction of a story, which is addressed in the workshop Developing Effective Oral Presentations, MCF22.)
 
 
Delegates should include medical writers, particularly those who work within, or for, pharmaceutical companies; project managers (whether by actual title or function); and others with responsibility for overseeing and coordinating multifunctional projects. Participants should have at least 1 year’s experience working within a matrix environment.
 
 
The workshop is for everybody who has come into contact with the statistical technique of Kaplan-Meier survival analysis and who wants to know more about what it means. Ideally you should have encountered such analyses in the context of clinical trials. Some minimal statistical understanding is needed and terms like ‘median’, ‘mean’, ‘confidence interval’, ‘risk’ , and ‘p-value’ should not terrify you.
 
 
The workshop is for everybody who has come into contact with the statistical technique of Kaplan-Meier survival analysis and who wants to know more about what it means. Ideally you should have encountered such analyses in the context of clinical trials. Some minimal statistical understanding is needed and terms like ‘median’, ‘mean’, ‘confidence interval’, ‘risk’ , and ‘p-value’ should not terrify you.
 
 
Medical writers and editors with 2–4 years of experience.
 
 
This workshop is for experienced medical writers who want to learn how to interpret and to report the performance characteristics of diagnostic tests.
 
 
Medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers often working to tight protocol and study report writing timelines because of inadequate scheduling of the processes leading up to and driving preparation of these documents. This is an ideal forum for writers whose organisations or clients have scope to improve their analysis and reporting processes and procedures.
 
 
Medical writers who wish to understand the analyses of binary data (i.e. yes/no outcomes such as death, response to treatment etc.). Participants should be familiar with basic statistical concepts such as P-values and confidence intervals.
 
 
Medical writers who wish to understand analysis of variance, linear regression, and other methods for the analysis of normally distributed continuous data. Participants should be familiar with basic statistical concepts such as P values and confidence intervals.
 
 
Medical writers and editors with 0-4 years of experience
 
 
This workshop will be of use to all medical writers who need to read published medical papers and interpret their findings. Participants should have a basic grasp of trial design (parallel groups, crossovers, etc.) and recognition of (but not necessarily practical experience of using) common statistical tests (e.g. chi-squared, t-test).
 
 
This workshop is aimed at all writers who find they have trouble fitting all their workload into a standard working week.
 
 
This workshop is for medical writers interested in understanding the most common rates, ratios, and measures of risk used in medical research.
 
 
This workshop is suitable for any medical writer with an interest in writing for the internet, whether already involved in this type of writing or not.
 
 
Anyone who wants to gain a better understanding of the basic concepts and theories of marketing.
 
 
This workshop will be useful to all medical writers who need to obtain specific medical information in order to complete their writing tasks, ranging from those working for pharmaceutical companies and CROs with large medical information departments, to freelance medical writers with no information support.
 
 
The workshop will be non-technical and will assume no previous economic or statistical knowledge. It will benefit medical writers of all backgrounds who want an introduction to the rapidly growing field of health economics and its use in medical decision making.
 
 
This workshop is aimed at medical writers who deal with health-related quality of life instruments (HRQoL) in clinical studies or document writing. No prior experience with HRQoL instruments is needed.
 
 
This workshop is aimed at staff and freelance medical writers who are interested in learning how they can make an effective contribution to the protocol writing process by taking a leading role. Previous participation in the workshop on The Clinical Study Protocol is recommended.
 
 
This workshop is targeted at medical writers who are aware of clinical studies, protocols, and clinical study reports.
 
 
Medical writers often need access to up to date relevant information in order to complete their writing tasks. The workshop will be useful to all writers ranging from those working for pharmaceutical companies and CROs with large medical information departments, to freelance medical writers with no information support. This workshop was previously run under the code PTF2 but it has changed significantly.
 
 
This workshop was previously run under the title 'Patient Registries as a Source of Medical Information’. This workshop addresses medical writers who prepare publications based on the data from research databases, patient registries and other real-life data sources. Basic knowledge of the design of observational studies, epidemiological research and statistics is not critical, but would be beneficial.
 
 
This workshop is designed to increase awareness and knowledge of Medical Information within the pharmaceutical industry, providing Medical Writers an alternative option in their Medical Writing career. Whilst no prerequisites workshops are required, participants are expected to have a basic understanding in drug development, dealing with US and EU regulations and medical education.
 
 
This workshop is aimed at medical writers looking to begin using Microsoft PowerPoint, or to refresh their basic skills.
 
 
This workshop is aimed at writers with limited experience of managing projects and those who need help in ensuring their deliverables meet client expectations and are delivered on time and on budget. The workshop does not cover project management of more complex multifunctional projects. These are covered in the Advanced Workshop “Do More with Less Faster: Project Management for Biomedical Communications”. Other related workshops include “Time Management for Medical Writers”.
 
 
Medical writers and editors with any level of experience who wish to learn more about the statistics they work with.
 
This workshop is aimed at medical writers who would like to improve their understanding of statistics. No previous knowledge of statistics is assumed, but a basic familiarity with what clinical trials are (eg experience with writing CSRs or publications of clinical trial results) would be helpful. Please note that this workshop is at a basic level and medical writers who are already experienced and confident in writing about statistical techniques may not benefit from it.
 
 
The workshop is aimed towards medical writers at all levels of experience, and whether working in a freelance capacity, or within a CRO environment, or for a pharmaceutical company. It will be an ideal forum for those who either have no quality control (QC) system in place, or are looking to develop one, whilst those with experience of working with, or implementing QC systems will be able to explore and share best practice. It is not necessary to have attended any other workshops.
 
 
This workshop is for participants who wish to develop or refresh their understanding of how basic statistical testing procedures work. Participants should: · be familiar with basic arithmetic, including squares and square roots · bring a calculator or smartphone app capable of square and square root functions · come prepared to engage in exercises and discussions
 
 
This workshop is aimed at medical writers who would like to improve their understanding of statistics. Prior attendance at “Basics of medical statistics for medical writers part 1” is not required; however, it is assumed that participants are already familiar with basic statistical concepts such as P values and estimation. Anyone who is not confident in their understanding of such concepts is encouraged to attend “Basics of medical statistics for medical writers part 1” before taking this workshop.
 
Medical writers with 0-4 years of experience. No prior knowledge in visual communication is required.
 
 
The workshop is particularly suited to medical writers who are writing documents entering the public domain. It will be most useful for those who either have no quality control (QC) system in place, or are now looking to develop one. For medical writers with greater experience it will provide a forum for discussion and sharing best practice. The workshop content is relevant to those working in a freelance capacity, as well as medical writers employed by CROs, communications agencies, or pharmaceutical companies.
 
 
Anyone who wishes to explore how to recognise a cultural issue or problem (particularly in a medical writing setting) and how to approach it wisely. Curiosity and willingness to share own experiences are the most important prerequisites.
 
 
This workshop is suitable for writers with any level of experience. Directors of writing groups will also find the method suitable for incorporation into the regular training of writers.