Joint MHRA/DIA Excellence in Pharmacovigilance

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

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TOPIC 2: REGULATORY ASPECTS IN PHARMACOVIGILANCE AND PRACTICAL EXAMPLES

Session Chair(s)

Phil Tregunno

Deputy Director - Patient Safety Monitoring

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

Gaby L. Danan, MD, PHD

Pharmacovigilance Expert

GLD, France

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)

SUSAR Reporting in Clinical Trials and Case Studies

Gaby L. Danan, MD, PHD

GLD, France

Pharmacovigilance Expert

Joint MHRA/DIA Excellence in Pharmacovigilance

TOPIC 2: REGULATORY ASPECTS IN PHARMACOVIGILANCE AND PRACTICAL EXAMPLES

Session Chair(s)

Phil Tregunno

Gaby L. Danan, MD, PHD

Speaker(s)

SUSAR Reporting in Clinical Trials and Case Studies

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