264 PD2M Panel Discussion Part 2- QbD based Filing: Realizing the Promise (Invited Talks)

Friday, November 20, 2020: 10:30 AM - 11:30 AM
Pharmaceutical Discovery, Development and Manufacturing Forum (26) (vFairs Auditorium)

Description:
This session will feature invited talks from the leaders in QbD filing arena from both the pharmaceutical industry and regulatory agencies elaborating on the current status, practices and perspectives. Emphasis will be on panel discussion with open Q&A to share recent experiences with QbD filing, evolution of regulatory environment along with the challenges and opportunities to do so.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Chair:
Nandkishor K. Nere Email: nandkishor.k.nere@abbvie.com
Co-chairs:
Moiz Diwan Email: moiz.diwan@abbvie.com
Nima Yazdanpanah Email: nima@procegence.com



10:40 AM
(264h) QbD based Filing: Realizing the Promise Panel Discussion
Timothy J. Watson, Kevin Fitzpatrick, Anita Lalloo, Pablo Rolandi, Billie Kline, Thomas D. Roper and Sharmista Chatterjee