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Interactive Regulatory Panel | This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space. This moderated and interactive discussion continues to be a much anticipated and highly rated session for this conference and is always informative; providing insights exclusively to conference attendees. together has changed the role of the industry and has driven value for the world. In our closing plenary session, we will hear from Joydeep Ganguly, SVP of Gilead, regarding how 2020 redefined the role and the value drivers of their efforts. We will also have Rick Friedman, Deputy Director, Science & Regulatory Policy, Office of Manufacturing Quality, CDER/FDA speak about the advantages of modern manufacturing. The session will conclude with a panel discussion including industry and regulatory leaders.
Speaker(s):
Mr. Michael
G. Higgins,
Sr. Director External Engagement and Supplier Quality,
Moderna Therapeutics
Alonza
Cruse,
Director, Office of Pharmaceutical Quality Operations,
FDA/ORA
Paul
A. Gustafson,
2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor,
Regulatory Operations and Enforcement Branch (ROEB), Health Canada
Mr. Rick
Friedman,
Deputy Director, Office of Manufacturing Quality,
FDA/CDER
Brooke
Higgins,
Senior Policy Advisor for the Global Compliance Branch 3,
FDA/CDER
Robert
Sausville,
Director, Division of Case Management,
FDA/CBER/OMPT/OCBQ