RSNN Expert Meeting Report - Regulator-initiated studies for regulatory decision-making

10 February 2023
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On 25 October 2022 the RSNN organized an RSNN Expert Meeting on “Regulator-initiated studies for regulatory decision-making”. The full report of this Expert Meeting is available now. 

On a European level, the European Medicines Agency (EMA) is exploring the use of high quality real world data (RWD). For instance in decision-making through the Data Analysis and Real-World Interrogation Network (DARWIN EU®). DARWIN EU® includes a coordination center that is responsible for generating timely and trustworthy evidence from observational data sources containing high-quality RWD on usage, safety and efficacy of medicines. The aim is to support regulatory decision making within the EU by the end of 2024.

The question arises what the role of various stakeholders, such as academia and industry, should be within these regulator-initiated studies, that make use of RWD. When and how will these stakeholders be included and which role each stakeholder has (informed, consulted, review, etc.): from the formulation of the study hypothesis to reviewing the study outcomes? To answer these questions, various international experts from academia, industry and governmental bodies were invited to share their current knowledge and personal views under the Chatham House Rules.

The full report is now available here.