European Medicines Agency and Massachusetts Institute of Technology launch joint project on regulatory science

News 11/11/2010

11/11/2010 - The European Medicines Agency and the Massachusetts Institute of Technology's (MIT's) Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals.

Specific questions addressed by this project include how to:

  • adapt current regulatory requirements to support the efficient development of safe and effective drugs;
  • incorporate patient valuation of health outcomes and benefit-risk preferences into regulatory decision-making;
  • implement 'staggered' and 'progressive' approaches to drug approval;
  • improve fulfillment of post-marketing regulatory requirements.

The data and recommendations from this project are expected to link to implementation of the Agency's Roadmap to 2015 and the CBI's New Drug Development Paradigms (NEWDIGS) research programme. The project will explore the feasibility of, priorities for and practical considerations of implementing demonstration projects on some of the issues addressed during the course of the research.

The project, which is scheduled to be completed by December 2011, will be conducted within the framework of CBI's NEWDIGS research programme in co-operation with the Agency and CIS.

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