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Wednesday, June 21 • 10:30am - 11:45am
#330: Managing Acceleration and Quality In Product Development

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss if we are progressing; Identify the gaps and concern; Describe if acceleration breed other issues to mitigate.

Chair

Diane J. Zezza

Speaker

Acceleration in Drug Development: Current State
Diane J. Zezza

Acceleration in Development: An Industry Perspective
Nirdosh Jagota, PhD

Accelerated Reviews and Product Quality: Responding to Patient Needs With Appropriate Urgency
Anamitro Banerjee



Speakers
avatar for Anamitro Banerjee

Anamitro Banerjee

Branch Chief (Acting), ONDP, OPQ, FDA, FDA
Dr. Banerjee currently serves as the Branch Chief (acting) in ONDP Branch 2 supporting the OHOP clinical divisions. He acted as a QAL/CMC Lead for OND’s DTOP for a year and was a CMC reviewer for NDAs and sNDAs in ONDQA since 2008. Prior to FDA, he served as a chemistry faculty... Read More →
avatar for Nirdosh Jagota

Nirdosh Jagota

Vice President and Head, Regulatory CMC, Merck & Co., Inc.
Nirdosh Jagota serves as VP and Head of CMC, Global Regulatory Affairs at Merck. Nirdosh has 25 years of pharmaceutical industry experience including 18 years in global regulatory management. Prior to Merck, he was VP, Regulatory CMC at Genentech/Roche. Before joining Genentech/R... Read More →
avatar for Diane Zezza

Diane Zezza

Vice President and Global Head, Regulatory CMC, Novartis Pharmaceuticals Corporation
Diane Zezza is Vice President and Global Head Regulatory Affairs, CMC at Novartis Pharmaceuticals. Diane has global responsibilities for CMC regulatory strategies/submissions for all development and lifecycle products. Diane has been a speaker at conferences on regulatory topics... Read More →


Wednesday June 21, 2017 10:30am - 11:45am
S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Credit Type CME, IACET, RN
  • Tags Session