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Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements.

TOPIC 2 SESSION 3: Preparation of Periodic Safety Update Reports (PSURs)

Session Chair(s)

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France
Phil Tregunno

Phil Tregunno

  • Head of Vigilance Operations, Safety & Surveillance
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Speaker(s)

Vicki Edwards

Preparation of Periodic Safety Update Reports (PSURs)

Vicki Edwards

  • Vice President, Pharmacovigilance Excellence and International QPPV
  • AbbVie, Inc., United Kingdom
Margaret Anne Walters

Preparation of Periodic Safety Update Reports (PSURs)

Margaret Anne Walters

  • Deputy EU Qualified Person for Pharmacovigilance
  • Merck, Sharp & Dohme Ltd, United Kingdom

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+41 61 225 51 51

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+41 61 225 51 55