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Session 9B: The Divide Between Small and Large Molecule Drugs: Myths and Realities…
Session Chair(s)
Wassim Nashabeh, PHD
Vice President, Global Head of Technical Regulatory Policy & International Ops
Genentech, A Member of the Roche Group, United States
This session will feature an interactive panel discussion on the similarities and differences between small and large molecule drugs development and regulatory approaches. Are these two classes of molecules so uniquely different that warrant different scientific and regulatory principles. What shared lessons can we learn between them when it comes to enhanced process and product understanding, quality risk management, establishment of control strategy, science-based regulatory framework and international regulations and harmonization. The panel will explore these themes with active engagement and participation from the audience. Come prepared with your questions and keep an open curious mind…
Speaker(s)
Panelist
Joseph Famulare
Genentech, A Member of the Roche Group, United States
Vice President, Global Compliance and External Collaboration
Panelist
Dr. Peter Richardson, PHD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
Panelist
Nirdosh Jagota, PHD
GRQ Biotech Advisors LLC, United States
Managing Partner
Panelist
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER