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Crowne Plaza London - The City

2018年6月05日 (火) 午前 8:00 - 2018年6月06日 (水) 午後 3:30

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

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

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

Michael Richardson, MD, FFPM, FRCP

Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom

QPPV Oversight and Compliance: Big Pharma perspective

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