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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: REGULATORY ASPECTS IN PHARMACOVIGILANCE AND PRACTICAL EXAMPLES. SESSION 1: SUSAR Reporting in Clinical Trials and Case Studies

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

The roles and responsibilities of marketing authorisation holders and national Competent Authorities in the conduct of Pharmacovigilance are defined in EU legislation and further detailed in the Good Pharmacovigilance Practices (GVP). Topic 2 will provide the safety reporting requirements with case studies, the roles and responsibilities of all stakeholders of clinical trials in line with the implementing texts published in relation to Directive 2001/20/EC and the new Regulation (EU) 536/2014. It will also cover individual and periodic adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase and illustrations based on case studies. This session will provide an understanding of safety data classification, using MedDRA terminology and safety data retrieval using Standardised MedDRA Queries (SMQs). Key elements will be provided for the establishment of a quality system in Pharmacovigilance including aspects of the applicable GVP modules, the elaboration of Standard Operating Procedures (SOPs) and the preparation for audits and inspections.

Speaker(s)

Gaby L. Danan, MD, PhD

SUSAR Reporting in Clinical Trials and Case Studies

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France

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+41 61 225 51 51

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