戻る Agenda
Session 1: Regulatory Outlook for Europe
Session Chair(s)
Aimad Torqui
Head of Division European cooperation and veterinary affairs
MEB, Netherlands
The session will discuss recent developments and future prospects in the EU regulatory landscape and their practical implications for development and approval of biosimilars.
Speaker(s)
Overview of the Immunogenicity Guideline
Venke Skibeli
Norwegian Medicines Agency, Norway
Other guidelines under revision and future trends
Thijs Giezen, PHARMD, PHD, MSC
Medicines Evaluation Board, Netherlands
Biosimilars for Rare Diseases
Richard L Dicicco
Harvest Moon Pharmaceuticals, United States