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Session 5, Track A: Management of Product Lifecycle: Challenges and Suggested Solutions
Session Chair(s)
Flavia Firmino, PHARMD
Regulatory Policy Lead - Latin America, Eli Lilly and Company, Brazil
Juliana Leite-Schnell
Director, Abbvie, United States
In this session, participants will gain a comprehensive understanding of the challenges and constraints caused by delays in the implementation of PACs (post-approval changes) in the pharmaceutical industry. The session will provide an in-depth analysis of the impact on the supply of medicines to patients and explore suggested solutions to develop processes for implementing changes efficiently. Participants will also have the opportunity to identify and discuss the opportunities and challenges faced by regulators and the industry in implementing reliance, particularly in the context of PACs. Additionally, the session will delve into the effect of regulations on global PACs registration strategies, allowing attendees to develop a strategic approach to navigate this complex landscape.
Learning Objective : - Identify the challenges and constraints caused by delays in the implementation of PACs in the pharmaceutical industry
- Suggest solutions for creating processes for implementing changes efficiently in the context of PACs
- Explore the effect of regulations on global PACs registration strategies and identify strategic approaches for navigating this complex landscape
Speaker(s)
Gloria Bocardo
Prin. Scientist, Regulatory Affairs-CMC, Merck Sharp & Dohme Farmaceutica Ltda, Brazil
How Product Supply is Impacted by Delayed Implementation of PACs
Isabelle Colmagne-Poulard, PHARMD, MBA, MSC
Head, International Global Regulatory & Scientific Policy, Merck, Switzerland
Global Frameworks for Post-Approval Changes in Biological Products
Patricia Oliveira Pereira Tagliari, LLM, MPH
Associate Director of the Second Directorate, ANVISA, Brazil
Management of Product Lifecycle: Challenges and Possible Solutions
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