European Medicines Agency hosts training course for GCP inspectors from countries across the world
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Compliance and inspections
Medicines
The European Medicines Agency has held a three-day training course on good clinical practice (GCP) inspections with participants from the European Union (EU), as well as 17 countries outside the EU.
The training course, which ended today, shows the Agency's commitment to working with authorities in countries outside the EU. It contributed to co-operation between regulators, ensuring that a robust framework is in place for the supervision and conduct of clinical trials, no matter where investigator sites are located and where patients are recruited.
The course participants came from the EU and from Brazil, Chinese Taipei, Croatia, the former Yugoslav Republic of Macedonia, Ghana, Indonesia, Japan, Malawi, Mexico, Montenegro, Nigeria, the Russian Federation, Saudi Arabia, Serbia, Singapore, Switzerland, the United States of America and Zambia. Representatives from the World Health Organization (WHO) also attended.
The course formed part of the Agency's strategy on the acceptance of clinical trials in marketing-authorisation applications. This is in line with the objectives in the Agency's 'Road map to 2015' and the work of the International Conference on Harmonisation (ICH) Regulators Forum.