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Session 1: Learnings and Best Practices for Variations: The International Perspective
Session Chair(s)
Susanne Winterscheid, PMP
Head of Licensing Division 3
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Post-approval change systems have a big impact on the management of the global supply chain of medicines and vaccines and are a major part of regulatory maintenance work. This session will highlight the experience gained from the European Variation Legislation and provide an outlook on the future development and evolution as part of the implementation of newly adopted ICH Quality guidelines (Q12). It will further provide insights into the concept of regulatory reliance as a tool for implementing smart regulation to facilitate regulatory activities.
Speaker(s)
Experience with the EU Variation Legislation, Current Discussions and Outlook
Susanne Winterscheid, PMP
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Head of Licensing Division 3
Post-Approval Change Management from a Manufacturing/Supply Chain Perspective: Including Regulatory Reliance as a New Concept
Melly Lin, MS
F. Hoffmann-La Roche Ltd, Switzerland
CMC Regulatory Policy Lead, Pharma Technical Regulatory
Outlook on new ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guideline
Frank Montgomery, PhD
AstraZeneca, United Kingdom
Global Head Regulatory CMC, GRAPSQA
Reliance as a Facilitator of Regulatory Activities
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Post-Approval Changes to Marketing Authorisations Training Courses
Ana Holt
The World Bank, United States
Senior Health Specialist
Loubna Djemame, MSc
World Bank, United States
Consultant, Health, Nutrition and Population
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