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Managing Acceleration and Quality In Product Development
Session Chair(s)
Diane J. Zezza
Vice President and Global Head, Regulatory CMC
Novartis Pharmaceuticals Corporation, United States
Options for acceleration of regulatory reviews and approvals has dramatically reduced the time devoted to traditional product development and, not surprisingly, increased the frequency of applications under accelerated timelines. However the acceleration of product development and regulatory review has introduced challenges for industry and regulatory authorities, particularly for CMC/quality expectations. This session will focus on recent experience toward approaches to balance and reconcile acceleration with appropriate demonstration of quality in product development and commercialization. Suggested topics for presentation and discussion include: Successful strategies for managing rolling submissions; Establishing an appropriate threshold for CMC under accelerated regulatory review; Global trends in acceleration of regulatory reviews and approvals;Managing the connection between clinical and CMC development during accelerated product development; Feasibility of simultaneous accelerated regulatory applications; Benefit/Risk decisions; What is the opportunity for conditional approvals?
Learning Objective : Discuss if we are progressing; Identify the gaps and concern; Describe if acceleration breed other issues to mitigate.
Speaker(s)
Acceleration in Drug Development: Current State
Diane J. Zezza
Novartis Pharmaceuticals Corporation, United States
Vice President and Global Head, Regulatory CMC
Acceleration in Development: An Industry Perspective
Nirdosh Jagota, PHD
GRQ Biotech Advisors LLC, United States
Managing Partner
Accelerated Reviews and Product Quality: Responding to Patient Needs With Appropriate Urgency
Anamitro Banerjee, PHD
FDA, United States
Branch Chief, ONDP, OPQ, CDER