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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)
Harshil Patel, MPharm
Senior Manager AR&RM – RMP, Novartis , India
Industry Insights: Navigating the implementation of GVP Module XVI Revision 3
Luvanka Kalliopi Hanxhari
Senior Manager AR&RM – RMP, Novartis, Switzerland
Industry Insights: Navigating the implementation of GVP Module XVI Revision 3
Robert Massouh, MPharm, RPh
Head of Safety (PV) Risk Management and Benefit/Risk Evaluation, GSK, United Kingdom
Industry perspective regarding joint PASS studies
Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
GVP XVI (Rev. 3) and considerations for digital aRMM
Ryan Marshall
Risk Management Director, AstraZeneca, United Kingdom
GVP XVI (Rev. 3) and considerations for digital aRMM
Jan Petracek, MD, MSc
CEO, iVigee Services a.s., Czech Republic
Use Case - additional risk minimization design and delivery boosted by AI
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