Overview
This workshop, through plenary and parallel breakout sessions, will focus on current challenging topics within the global pharmaceutical/biopharmaceutical arena. Attendees from different CMC areas will be given the opportunity to interact with representatives from global Regulatory Agencies and Industry in sessions enabling cross-functional discussions.
This program was developed by the CMC Working Group of the DIA Regulatory Affairs Community.
This program is co-sponsored by the American Association of Pharmaceutical Scientists.
Program Committee
-
Yasmin de Faria Krim, PharmD, MSc CMC working group
Chair, CMC Working Group, DIA Regulatory Affairs Community, France -
Lin-Jau (Christine) Wu Anderson, BSN, MSc, RAC Senior Research Scientist, Global Regulatory, Chemistry, Manufacturing & Control
Eli Lilly and Company, US, United States -
Nagesh Bandi, PhD Executive Director
Merck & Co., Inc, United States -
Ganapathy Mohan, PhD Head of External Affairs (Quality)
Merck & Co., Inc., United States -
Elaine Morefield, PhD, RPh Vice President, Regulatory Affairs
VaxForm, LLC., United States -
Moheb M. Nasr, PhD, MS Principal
Nasr Pharma Regulatory Consulting, United States -
Peter Richardson, PhD Head of Quality, Specialised Scientific Disciplines Department
European Medicines Agency, Netherlands -
Jean-Louis Robert, PhD Former CHMP/CVMP QWP Chair
Luxembourg -
Ramesh K. Sood, PhD Senior Scientific Advisor (Acting), Office of New Drug Products, CDER
FDA, United States -
T. Venkateshwaran, PhD Vice President and Global Head CMC Biologics, Medical Devices and Comb
Merck & Co., Inc., United States
Have an account?