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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, 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
Emerging Therapies, Evolving Regulations: Navigating Safety and Risk in a Complex Landscape
Vineet Kacker, PhD
APCER Life Sciences, United Kingdom
Managing Director & Global Technical Head
Keeping Track of Worldwide PV Regulatory Intelligence and CAPA Trending
Speaker Invited
India
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