New Jersey Chapter: European Data Privacy Roadmap: Balancing Research, Innovation, and Compliance (ACRP 2025 Conference Replay)
This event will be presenting a session replay from the ACRP Conference Library
Event Description:
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.
Speakers:
Rob Masson
Learning Objectives:
- Identify and understand key data privacy compliance challenges for contract research organizations and sponsors, with examples and insights.
- Understand the implications of EU regulations (GDPR, CTR, MDR, AI Act, Data Act) and other jurisdictional requirements, including complexities in processing EU/UK trial participants’ data.
- Recognize when to appoint a data privacy officer or representative and understand what is required for effective data governance under the CTR and MDR.
Registration & ACRP Contact Hour Information:
- Chapter Member (registration with or without contact hours): $0
- ACRP Member (registration only): $5
- ACRP Member (registration + contact hours): $20
- Non-Member (registration only): $10
- Non-Member (registration + contact hours): $40
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