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The European Medicines Agency today published a meeting report reflecting discussions and comments made on its draft 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 European Medicines Agency.

The discussions took place during an international workshop held in September 2010.

The workshop, which brought together 140 European and international participants from 43 countries, represents part of the public consultation process on the reflection paper.

All comments received during the workshop and in writing as part of the public consultation are currently being reviewed before the final version of the reflection paper is agreed and published later this year.

The slides from the presentations given during the workshop are also available to download.

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The workshop will enable participants to discuss and provide feedback on the ‘Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorization applications to the EMA’ which was released for public consultation on the Agency’s website in May 2010. The workshop complements this consultation process. Conclusions from the workshop and copies of the presentations will be subsequently published in a short report. Please note that registration for the workshop is now closed.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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The FDA and the EMEA will be sharing information on inspection planning, policy and outcomes and they will be collaboration on inspections.There is an EMEA press release here.

Announcing this pilot Thomas Lönngren, the European Medicines Agency’s Executive Director said: “This important initiative demonstrates the increasing collaboration between the European Medicines Agency and the FDA. It marks an important step to the building of a global regulatory network for supervision of clinical trials. By working together in a collaborative and synergistic manner GCP inspection resources can be used more efficiently.”

The Key Objectives Are:

• To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
• To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
• To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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