In an increasingly connected world, clinical trials and other research activities are no longer state- or country-specific. Not surprisingly, the globalization of research activities creates any number of legal and compliance challenges for stakeholders involved in the development, authorization, and commercialization of medicinal products, including under data privacy regulations that continue to evolve.
This hybrid meeting addressed some of the most pressing of these challenges. We addressed issues that go to the heart of the General Data Protection Regulation (“GDPR”) of the European Union (“EU”), such as what constitutes a restricted international data transfer, the appropriate lawful basis to legitimize the processing of personal data in the context of clinical trials and secondary research, and the designations of parties participating in research as controllers and processors. We also discussed potential solutions to problems that continue to challenge the research community. The research community has been awaiting further guidance on the topic of the GDPR and research from the European Data Protection Board (“EDPB”) for several years. The research community must thus navigate several complex issues in the absence of relevant regulatory guidance.
This meeting consisted of a series of panels made up of experts from the life sciences industry, government, and academia to address key challenges faced by the research sector under the GDPR and data privacy regulations in other geographies, including the Personal Information Protection Law of the People’s Republic of China (“PIPL”).