RISK MINIMISATION STUDIES

Risky-Business-XL-Edited

RISK MINIMISATION STUDIES
June 2020 (date TBD)

Key Speaker: Marie Louise De Bruin, Professor in Regulatory Science at the Faculty of Health and Medical Sciences of the University of Copenhagen, Director of the Copenhagen Centre for Regulatory Science (CORS) at the Department of Pharmacy and Ex-PRAC member, EMA (2012 – 2018)

A systematic review of how to design and implement the evaluation of risk minimisation measures. Learn how to secure PRAC approval of your study.

The evaluation of risk minimisation measures is a regulatory requirement. In 90 minutes, get practical knowledge and advice to apply to your next field, secondary data or hybrid observational study to evaluate risk minimisation measures.

Areas covered will include:

  • Regulatory framework and expectations from regulators
  • Approaches & designs for risk minimisation studies
  • Decisions made by regulators on real studies
  • Real case studies from a systematic review, with unpublished information from EMA
  • Scientific and practical challenges

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