Challenges and Successes of ICH Q12 Related Submissions

Extended Learning
Learning Level: Advanced
Session Length: 2 hours

ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, is a transformative document that will shape global regulatory submissions and practices. Adopted in November 2019, it has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the definition of a pharmaceutical or biological product, as well as both new molecular entities and authorized products.

Learning Objectives

  1. Hear about case studies relating to the application of Q12 principles
  2. Learn about key areas of concern and interest from industry and regulatory perspectives
  3. Gain greater appreciation, clarity and value related to the application of Q12 principles
  4. Participate in an extended panel discussion with the invited experts via Q&A
Challenges and Successes of ICH Q12 Related Submissions
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Nina S. Cauchon, PhD
Director Regulatory Affairs - CMC
Amgen Inc.
Connie Langer
Director, CMC - Global Regulatory
Eli Zavialov, PhD
Senior Director
Kim Wolfram
Director, Global Regulatory CMC Biologics & Gene Therapy
Saroj Ramdas
Executive Director CMC Regulatory
Amicus Therapeutics
Joel Welch, PhD
Associate Director for Science, Office of Biotechnology Products (OBP)

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