Planning Ahead In The EU: The Impact Of The GDPR On Clinical Trials And Research

When it becomes effective in the EU in May, the new General Data Protection Regulation will have major implications for the planning and conduct of clinical trials and research. Lawyers David Pountney and Richard Binns discuss how pharmaceutical companies and CROs should plan to ensure they remain compliant.

Data protection
The new General Data Protection Regulation will come into effect in May • Source: Shutterstock

2018 is set to be a busy year for pharmaceutical companies engaged in clinical studies in the EU with both the new General Data Protection Regulation and the Clinical Trials Regulation coming into effect.

About The Authors: David Pountney is an associate at the London, UK, based office of law firm Simmons & Simmons LLP. Richard Binns is a partner at the same firm.

The GDPR (Regulation (EU) 2016/679) will be effective from May 25, 2018 without any transitional period. It replaces the existing...

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