Date :
Place : United States, Raliegh
Contact Person:Paula Edwards
Description:
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar productsDeadline for abstracts/proposals : 1st August 2017
Organized By :New York Events List
Keynote Speakers : Salma Michor PhD, MSc, MBA, CMgr, RAC Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in
Conference Highlights :The regulation of Biosimilars is very complex and the approach used by various regions differs. Professionals working in this complex area should be equipped with the latest knowledge and keep abreast of current and new legislation and requirements in this field in order to gain market access for their products.
Venue :Morrisville, NC 27560, United States
Check the event website for more details.