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European Biopharmaceutical Review

EU Impact

25 May 2018 is an important date for pharmaceutical companies, CROs, software vendors and others supporting drug development, as this is when the new EU General Data Protection Regulation (GDPR) – what the EU calls “the most important change in data privacy regulation in 20 years” – comes into effect (1).

The new rules replace the 1995 Data Protection Directive 95/46/EC and are meant to harmonise data privacy laws across Europe, as well as “to protect and empower all EU citizens’ data privacy”. The GDPR will have a significant impact on how patient data are handled as it changes the way organisations approach information security.

When GDPR comes into effect, national governments will not be required to pass enabling legislation. The regulation will be applicable immediately, and serious violations may result in fines of €20 million or 4% of the organisation's worldwide revenues.

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Jon Weisberg, Industry Advisor for EBR, heads public relations and communications for SAFE-BioPharma Association. He provides comprehensive editorial and consulting services to life sciences organisations.
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Jon Weisberg
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