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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…

Michael DiMaio.

New HHS Advisory Opinions Support Broad Application of PREP Act Immunity for COVID-19 Response

USA - November 3 2020 The United States Department of Health and Human Services ("HHS") Office of General Counsel ("OGC") recently issued two advisory opinions (20-03 and…

Gregory H. Levine, Joshua Oyster.

Accessing New Research Funding Opportunities During and After COVID-19

USA - May 7 2020 As the COVID-19 pandemic continues to strain research operations, the federal government is responding with flexibilities for funding applicants and…

Christina A. Ravelo, Elana Bengualid Harary, Mark Barnes, Valerie H. Bonham.

Phasing-In: Use of COVID-19 Testing as a “Return to Work” Strategy

USA - April 29 2020 As “stay-at-home” orders approach expiration or are lifted, it appears that a return to the workplace through “phasing-in” is rapidly approaching…

Deborah Gersh, Douglas Brayley, Mark Barnes, Megan Bisk, Timothy M. McCrystal.

COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by Key European National Regulatory Authorities, the Australian Department of Health, Brazil’s ANVISA, Health Canada and Singapore’s HSA

Australia, Brazil, Canada, European Union, France, Germany, Italy, Singapore, Spain, Switzerland - April 8 2020 The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, National authorities have issued…

Alexis Kral, Elizabeth King, Mark Barnes.