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Session 1 - first experiences and practical aspects
Session Chair(s)
Ulla Wändel Liminga, DrMed, MS, RPh
Scientific Director Pharmacology/Toxicology
Medical Products Agency (MPA), Sweden
Speaker(s)
Industry Insights: Navigating the implementation of GVP Module XVI Revision 3
Harshil Patel, MPharm
Novartis , India
Senior Manager AR&RM – RMP
Industry Insights: Navigating the implementation of GVP Module XVI Revision 3
Luvanka Kalliopi Hanxhari
Novartis, Switzerland
Senior Manager AR&RM – RMP
Industry perspective regarding joint PASS studies
Robert Massouh, MPharm, RPh
GSK, United Kingdom
Head of (Safety) Risk Management and Benefit/Risk Evaluation
GVP XVI (Rev. 3) and considerations for digital aRMM
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
GVP XVI (Rev. 3) and considerations for digital aRMM
Ryan Marshall
AstraZeneca, United Kingdom
Associate Director, Risk Management
Use Case - additional risk minimization design and delivery boosted by AI
Jan Petracek, MD, MSc
Ivigee, Czech Republic
CEO
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