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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 5 SESSION 4: Post-authorisation Development Plan (PASS/PAES)

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


Jan  Petracek, MD, MSc

Post-authorisation Development Plan (PASS/PAES)

Jan Petracek, MD, MSc

  • Director
  • Institute of Pharmacovigilance, Czech Republic

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