Press Release: European Medicines Agency holds international workshop on clinical trials in the context of global medicines development

The European Medicines Agency (EMA), on 6-7 September 2010, 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 that has at its heart the protection of the rights, safety and wellbeing of patients participating in clinical trials anywhere in the world.

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’.

• Primary Source

EMA: Regulatory: Human medicines: Inspections: Good clinical practice compliance http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000072.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800268ad&jsenabled=true

EMA: Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA (Draft), May 2010 http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/06/WC500091530.pdf

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