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Session 3: Pharmacovigilance Agreements
Session Chair(s)
Reena Harjai, MD
Vice President, Pharmacovigilance, Inovio Pharmaceuticals, United States
Companies that hold a marketing authorization in various territories must have a well-planned, structured document in place to define the responsibilities of each party. Ensuring the inclusion of key terms, responsibilities, and monitoring compliance can be challenging, but is essential to be compliant with the regulatory requirements to be more compliant.
Speaker(s)
Anna Adams, PHD, MSC
Senior GPvP Inspector, Inspection, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Regulator Perspective
Vineet Kacker, PHD
Managing Director & Global Technical Head, APCER Life Sciences, United Kingdom
QPPV Oversight and Compliance: Small Pharma perspective
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom
QPPV Oversight and Compliance: Big Pharma perspective