Effective data governance is crucial for organizations involved in clinical research for drug and medical device development. However, the implications of evolving European Union (EU) laws, such as the General Data Protection Regulation (GDPR), Clinical Trials Regulation (CTR), Medical Device Regulation (MDR), Artificial Intelligence (Ai) Act, and Data Act, bring many new challenges. This session will explore some of the key data privacy compliance challenges for contract research organizations and sponsors, sharing real-world business examples and insights. The implications of the CTR, MDR, AI Act, and other jurisdictional regulations will be explored, focusing on the complexities of processing EU/United Kingdom trial participants’ data. Guidance on when to appoint a data privacy officer and representative will also be provided. Attendees will gain a deeper understanding of how to identify the challenges posed by privacy laws, particularly the EU’s GDPR, and recognize what is required for effective data governance under the CTR and MDR.

CEU: 1.00 ACRP

Speaker:

• Rob Masson, CEO, The DPO, Centre

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