Category Archive: EU

Jul 20 2020

Are you ready for the new European clinical trial regulation?

29 June 2020 – Cleo François MSc, Regulatory Affairs Manager The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is …

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Jan 17 2019

Stay on the Safe Side- Reference Safety Information – Europe

Vivienne Ben-David, B.Sc. (Pharmacy) PGDip. Project Manager & Associate Director, Pharmacovigilance ROW Cato Research   Aside from New Year’s resolutions and a clean sweep, what else should you refresh in 2019? I politely suggest your understanding of Reference Safety Information (RSI) in the EU. In Nov 2017, the Clinical Trials Facilitation Group published the Reference …

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