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Will Consent Be Disfavored as Basis for Processing Personal Data in Clinical Research Under EU Data Protection Law?

European Union, United Kingdom, USA - June 18 2018 The European General Data Protection Regulation ("GDPR"), which took effect on May 25, 2018, requires that all processing of personal data subject…

Mark Barnes, David Peloquin

New GDPR Guidance from European Commission on Interaction between EU Clinical Trials Regulation and GDPR

European Union, USA - April 22 2019 On April 10, 2019, the European Commission Directorate-General for Health and Food Safety (the “EU Commission”) issued new guidance (the “Q&A”) on…

Mark Barnes, David Peloquin

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

European Union - February 12 2021 Last week, the European Data Protection Board (the “EDPB”) released new guidance on the application of the European Union General Data Protection…

David Peloquin

Use of 'ticking fee' in Novartis-AveXis transaction

USA - November 14 2018 On 6 April 2018 Novartis AG entered into a definitive agreement to acquire AveXis, Inc - a US-based, clinical stage gene therapy company - for…

Martin J. Crisp, John E. Sorkin, Marvin Tagaban

Podcast: COVID-19: Global Health Care Compliance: Managing Compliance Issues and Process Changes Related to the Pandemic

China, Japan, USA - June 4 2020 In this Ropes & Gray podcast, moderated by health care associate Michael DiMaio, the co-leaders of the firm's Global Health Care Compliance…

Alison Fethke, Amanda N. Raad, Kaede Toh