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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)
Regulator Perspective
Anna Adams, PhD, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Senior GPvP Inspector, Inspection, Enforcement and Standards
QPPV Oversight and Compliance: Small Pharma perspective
Vineet Kacker, PhD
APCER Life Sciences Limited, United Kingdom
Managing Director and Global Technical Head
QPPV Oversight and Compliance: Big Pharma perspective
Michael Richardson, MD, FFPM, FRCP
Bristol-Myers Squibb, United Kingdom
Senior Vice President, WorldWide Patient Safety