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Session 3: Lifecycle Management
Session Chair(s)
Ana Padua, MSc, RPh
Director EU Global Regulatory and Scientific Policy , Merck Kgaa, Darmstadt, Germany (EMD Serono, US), Switzerland
Leonardo Semprun, PharmD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
This session will discuss 2 aspect related to the lifecycle management of pharmaceutical products.
- The concept Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry (1VQ concept paper). How is possible to achieve a transformational shift with faster implementation of new knowledge, continual improvement, and innovation through post-approval changes
- Applicability of Post-Approval Change Management Protocols (PACMPs). Current adoption and implementation status worldwide, and benefits
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the concept of Post-Approval Change Management Protocols (PACMPs)
- Understand Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry
- Discuss the opportunities that this initiative could bring to the region
Speaker(s)
Anders Vinther, PhD, MSc
Founder and Chief Executive Officer, QBA Leaders, United States
1VQ Concept Paper- Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry
Sylvie Meillerais, MSc
Head of CMC Excellence, Institut De Recherches Internationales Servier, France
Post-Approval Change Management Protocols (PACMPs)
Raphael Sanches Pereira
General Manager of the Office for Medicines, ANVISA, Brazil
Recent Advances in the Development of PAC Guidelines