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Session 1: Globalization in the CMC Area - Collaboration Between Regulatory Agencies
Session Chair(s)
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair
Luxembourg
From the hurdles of getting global regulatory approvals through updates on the EMA/FDA parallel assessment pilot program for QbD submissions or global activities for GMP inspection, this session will focus on globalization of activities in the area of both CMC assessment and GMP inspections. Current and future challenges as well as opportunities to facilitate global approvals of drugs will be addressed through feedback from representatives from both Industry and Agencies. A Question/Answer session will provide attendees with the opportunity to comment and share their thoughts on current initiatives.
Speaker(s)
Challenges in Getting Global Regulatory Approvals
Ganapathy Mohan, PhD
Merck & Co., Inc., United States
Head of External Affairs (Quality)
Lessons Learned Developing a Global QbD Pilot for Biologics
Lynne Krummen, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Technical Regulatory, Biologics
FDA Update on Inspection Globalization Activities
Diana Amador Toro, PhD
FDA, United States
Director, New Jersey District, Office of Regulatory Affairs
Q&A Panel (including above speakers)
Elaine Morefield, PhD, RPh
VaxForm, LLC., United States
Vice President, Regulatory Affairs
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