CTU Bern (Clinical Trials Unit)

European Medicines Agency (EMA) launches website for academic researchers

The European Medicines Agency (EMA) aims at maintaining a strong working relationship with European academics and researchers. Collaboration between the Agency and academia is necessary for the EMA to be prepared for future challenges and opportunities offered by advances in science and technology.

The EMA has therefore developed a framework to formalise, structure and further develop interactions with the academic community in the context of the European medicines regulatory network. The framework wishes to:

  • raise awareness of the mandate and work of the European medicines regulatory network to increase academia’s trust in and engagement with the regulatory system;
  • foster the translation of academic research into novel methodologies and medicines which meet regulatory standards and address needs of public and animal health;
  • ensure that the best scientific expertise and academic research are available on time to support effective evidence generation, regulatory advice and guidance, as well as decision-making in regulatory processes;
  • collaborate with academia to develop regulatory science that embraces scientific progress in medicines development without compromising patient safety, such as for example, the use of novel endpoints or novel methodologies.

The newly launched website for academia provides information on the EMA’s activities that are most relevant to academia, including news regarding current topics and events of interest.

In the section Research and development, the EMA provides:

  • Scientific and regulatory information on how to design and run clinical trials
  • Compliance standards
  • Obligations and incentives for developers of specialised medicines
  • Training resources

The full list of topics can be found here.

For more detailed information, please visit the EMA's website.

Source of information: http://www.ema.europa.eu/ema