DDA27 Medical Writing for Biosimilars

Description

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 field of Medical Writing.
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.