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PV.S1. – PV Global Regulatory Intelligence Updates
Session Chair(s)
J Vijay Venkatraman, MD, MBA
Managing Director and CEO
Oviya Medsafe Pvt Ltd, India
This session will provide a comprehensive update on the latest global regulatory developments in pharmacovigilance (PV), highlighting key changes, emerging trends, and regional variations that impact drug safety operations. Experts will discuss recent guidance from major health authorities such as the FDA, EMA, MHRA, PMDA, and CDSCO, as well as evolving expectations in regions like APAC, LATAM, and MENA. Attendees will gain actionable insights into how to align their PV systems with current regulations, navigate compliance challenges, and adopt a proactive approach to regulatory intelligence for risk mitigation and strategic planning.
Speaker(s)
EMA Strategies And Future Plans: PRAC Contribution, Master Data Management Plan and EU Network Data Strategy including Signal Management
Jose Alberto Ayala Ortiz, MPharm, MSc
PVpharm, Spain
CEO
The Immunogenicity Paradox: Harmonizing Pharmacovigilance Strategies Across Originator Biologics, Biosimilars, And Next-Generation Bispecific Antibodies
Prashant Joshi, RPh
Wipro Ltd. And Wipro Life Science (WLS), India
General Manager & Global Head Account Delivery, MDPS
Keeping Track of Worldwide PV Regulatory Intelligence and CAPA Trending
Prasad Deshmukh
Cipla, India
PV Head