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Art Gertel

Company:
MedSciCom, LLC
Qualification:
PhD
Leader background:
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.
Workshops:
Do More with Less Faster: Project Management for Biomedical Communications
    Level: Advanced Area: Professional Techniques
    Code: PTA2 Duration: 03:30:00
Serving Two Masters: Comparing and Contrasting US and EU Regulatory Submissions and Processes
    Level: Advanced Area: Drug Development
    Code: DDA7 Duration: 03:30:00
Opening Session and Welcome Lecture
    Level: Area: Plenary Lecture
    Code: XPL20Y Duration: 01:30:00
Ethical Issues in Clinical Trials
    Level: Foundation Area: Drug Development
    Code: DDF17a Duration: 03:30:00
Strategies for Improving Document Quality
    Level: Advanced Area: Professional Techniques
    Code: PTA11 Duration: 03:30:00
EMWA Budapest Working Group: Clarity and Openness in Reporting: E3-based
    Level: Area: Not for credit
    Code: XPBGW Duration: 00:40:00
EMWA/AMWA/ISMPP Joint Position Statement
    Level: Area:
    Code: sem01 Duration: 00:30:00
Responses to Authorities and the Role of the Medical Writer
    Level: Area: Expert Seminar Series Session 3 Regulatory
    Code: ESS20 Duration: 01:30:00
Opening Session
    Level: Area: Plenary Lecture
    Code: XPL20Y18 Duration: 01:30:00
An update on CORE reference - news, initiatives, and developments
    Level: Area: Expert Seminar Series
    Code: ESS32.5 Duration: 00:25:00