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Session 4 Track C-D: Transparency in Medical Writing: How Does the EU Clinical Trial Regulation Impact Medical Writers?
Session Chair(s)
Eileen Girten, MS
Medical Writing Therapeutic Area Lead
Pfizer, United States
The European Union (EU) Clinical Trial Regulation, which becomes effective in 2016, is going to change how clinical trials are conducted and reported. A major consequence of this regulation is the creation of study participant summaries for clinical trial results. This session will focus on the summaries and other sections of the EU Clinical Trial Regulation as they apply to medical writing.
Learning Objective : At the conclusion of this session, participants should be able to:
• Describe key aspects and specific changes of the EU Clinical Trial Regulation as they apply to medical writing
• Identify challenges for medical writing as a result of the EU Clinical Trial Regulation
• Describe the challenges and opportunities identified in returning results to participants of clinical trials
• Discuss best practices for clinical trial disclosure
Speaker(s)
Faculty
Barbara Godlew, RN
Eli Lilly and Company, United States
Associate Consultant, Scientific Communications, GSC-Bio-Medicines
Faculty
Deborah Collyar
Patient Advocates In Research (PAIR), United States
President