Outcome of EMA Workshop on Clinical Trials and Global Medicines Development

On 6-7 September 2010 the European Medicines Agency (EMA) held an international workshop with a broad cross section of stakeholders from around the world to discuss a way forward for a global framework of clinical trials.

The workshop was part of the consultation process on the Agency's 'Reflection Paper on ethical and Good Clinical Practice (GCP) aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA' (see our News from 9 June 2010). Some 170 participants from around 50 countries from the Americas, Asia, Africa and Europe came to the meeting at the Agency in London to provide their feedback on the draft Reflection Paper.

The discussions over the course of the two-day conference highlighted three main points:

  • The need for cooperation and networking between regulatory authorities and also ethics committees involved in the supervision of clinical trials, including capacity building activities.
  • The need for greater transparency of clinical trials, including clinical trials registers and the provision of information about ethical and GCP aspects in the European Public Assessment Report (EPAR).
  • The need to involve patients early on in the design of protocols to ensure the adequate protection of clinical trials subjects.

The consultation on the Reflection Paper is still open and ends on 30 September 2010. Comments should be sent to ctrefpaper@ema.europa.eu.

Source: EMA Press Release

Compiled by
Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA)

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