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Best Evidence Generation: Regulatory Perspectives
Session Chair(s)
Kevin Blake, MD, PhD
Clinical Epidemiologist
European Medicines Agency, Netherlands
The traditional model of medicines regulation sees decisions made based on evidence submitted by pharmaceutical companies. More recently, however, regulators are supplementing this evidence with that from other sources including research by independent third-parties or established networks. These other sources also include data and information generated by regulators themselves, e.g., the EMA using e-health data from The Health Improvement Network (THIN) and IMS. The issues around regulators conducting such research are explored in this session including details of some of the research conducted and how the results have translated into outcomes and also some of the challenges posed, such as ensuring transparency.
Learning Objective : Discuss the concepts of best evidence generation from the regulatory perspective; Explain the underlying rationale and the approaches used by regulators to generate evidence that supplements that which is generated by pharmaceutical companies to support regulatory decision making; Identify the potential gaps in data and information considered as important to regulators including on drug utilization and prescribing.
Speaker(s)
Best Evidence Generation: The European Medicines Agency Approach to In-House Analysis of e-Health Data
Kevin Blake, MD, PhD
European Medicines Agency, Netherlands
Clinical Epidemiologist
FDA's Approach to Incorporating Studies Using Electronic Health Care Data Into Regulatory Decision-Making
Judy Anne Staffa, PhD, RPh
FDA , United States
Associate Director for Public Health Initiatives, OSE, CDER
European Perspective
Andrzej Rys, MD
European Commission, European Union, Belgium
Principal Scientific Advisor
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