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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
MSD, Panama
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)
1VQ Concept Paper- Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry
Anders Vinther, PHD, MSC
QBA Leaders, United States
Founder and Chief Executive Officer
Post-Approval Change Management Protocols (PACMPs)
Sylvie Meillerais, MSC
Institut De Recherches Internationales Servier, France
Head of CMC Excellence
Recent Advances in the Development of PAC Guidelines
Raphael Sanches Pereira
ANVISA, Brazil
General Manager of the Office for Medicines