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Session 3: Lifecycle Management
Session Chair(s)
Ana Padua, MSc, RPh
Director EU Global Regulatory and Scientific Policy
EMD Serono, Switzerland
Leonardo Semprun, RPh
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, United States
Owner
Post-Approval Change Management Protocols (PACMPs)
Sylvie Meillerais, MSc
MSD Belgium, Belgium
Director Global CMC Policy
Recent Advances in the Development of PAC Guidelines
Raphael Sanches Pereira
ANVISA, Brazil
Quality Assessment of Synthetic Medicines Office Manager
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