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Crowne Plaza London - The City

05 jun 2018 8:00 a.m. - 06 jun 2018 3:30 p.m.

19 New Bridge Street, London, EC4V 6DB, United Kingdom

Pharmacovigilance Conference

Session 3: Pharmacovigilance Agreements

Session Chair(s)

Reena  Harjai, MD

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

Regulator Perspective

Anna Adams, PhD, MSc

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Senior GPvP Inspector, Inspection, Enforcement and Standards

Vineet  Kacker, PhD

QPPV Oversight and Compliance: Small Pharma perspective

Vineet Kacker, PhD

APCER Life Sciences Limited, United Kingdom

Managing Director and Global Technical Head

Michael  Richardson, MD, FFPM, FRCP

QPPV Oversight and Compliance: Big Pharma perspective

Michael Richardson, MD, FFPM, FRCP

Bristol-Myers Squibb, United Kingdom

Senior Vice President, WorldWide Patient Safety

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