Understanding the changes and impact of the EU Clinical Trial Regulation
European Union Clinical Trial Regulation 536/2014 (EU CTR) became applicable on January 31, 2022 and has introduced a more centralised approach to clinical trial conduct in the EU, enhanced transparency requirements, and a new GMP framework for Investigational Medicinal Products (IMPs).
Almac Clinical Services is ready to support delivery of your investigational products as you navigate the transition from Directive 2001/20/EC to Regulation 536/2014 and will continue to support the delivery of investigational products in the EU and beyond.
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