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Medical Writing for Biosimilars

Level:
Advanced
Area:
Drug Development
Code:
DDA27
Duration:
03:30:00
Workshop profile:
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.
Objective:
After completing the workshop, participants will have an understanding of the differences between biosimilars and NBE development. In addition, they will understand how these differences influence the development of clinical documents. They will appreciate the challenges they might face when working in this relatively new field of Medical Writing.
Content:
• General overview on biosimilars clinical development • Dealing with biosimilars clinical study reports (Phase I and Phase III) • Dealing with the clinical documents of a biosimilars submission dossier