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Radisson Blu

Jun 19, 2018 8:00 AM - Jun 19, 2018 5:00 PM

Steinentorstrasse 25, 4001 Basel, Switzerland

CMC Short Course

Instructors

Elaine  Morefield, PhD, RPh

Elaine Morefield, PhD, RPh

Vice President, Regulatory Affairs, VaxForm, LLC., United States

Dr. Elaine Morefield is the Vice President, Regulatory Affairs for Vaxform,LLC. where she provides regulatory and development consulting services to clients. She also is working for Aclaris Therapeutics Inc., as the director of Product Quality, She obtained her BS pharmacy and her PhD in industrial and physical pharmacy from Purdue University. Dr. Morefield worked in the Office of New Drug Quality Assessment at the US FDA where she was the deputy office director for review and administration. Dr. Morefield has over 30 years of product development experience with pharmaceutical companies Wyeth, Schering-Plough and DSM and has developed over 100 pharmaceutical products.

Yasmin  de Faria Krim, PharmD, MSc

Yasmin de Faria Krim, PharmD, MSc

CMC working group , Chair, CMC Working Group, DIA Regulatory Affairs Community, France

Yasmin de Faria Krim is an active volunteer at DIA, as chairperson of the CMC working group within the DIA Regulatory Affairs Community. She was the program chair for the last 4 DIA CMC workshops (Washington DC), co-sponsored by AAPS and has also chaired DIA webinars focusing on CMC topics. Yasmin currently works in the consultancy area in Switzerland, and has previously worked in Belgium and the UK, in CMC Regulatory Affairs and European Regulatory Affairs. Yasmin de Faria Krim holds a PharmD and a Master in Regulatory Affairs (International Drug Development and Registration).

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