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New European Data Protection Board (EDPB) Guidance Highlights – but Leaves Unresolved – Several GDPR Compliance Issues Facing Clinical Researchers

Last week, the European Data Protection Board (the “EDPB”) released new guidance on the application of the European Union General Data Protection Regulation (“GDPR”) to health research.

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COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by FDA, EMA, MHRA and PMDA

Practices: Health Care

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Coronavirus Landing Site

The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, national authorities have issued guidance for sponsors, investigators and institutional review boards (IRBs)/research ethics committees (RECs) regarding the conduct of clinical trials. The chart below summarizes guidance from the U.S. Food and Drug Administration (“FDA”) (updated March 27, 2020), the European Medicines Agency (“EMA”) (dated March 27, 2020), the United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”) (updated March 24, 2020), and Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) (dated March 27, 2020).

View the PDF to read the guidance.

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