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Session 5 Track 2: EU GDPR and Medical Writing
Session Chair(s)
Andrea Tuttle Meyers
Senior Vice President, Clinical Operations
Syneos Health, United States
The General Data Protection Regulation (GDPR) became enforceable in the European Union in May 2018. A panel discussion will explore the impact of the EU GDPR as it relates to clinical trials, specifically with regard to the impact on the production of clinical trial documents prepared by medical writers. The session will explore the changes and the challenges of implementing the EU GDPR in clinical trial documents with input from clinical trial industry leaders. It will also look at how this has impacted the pharmacovigilance system in the UK and how the MHRA have adapted their data collection systems. MHRA will also provide an update on Brexit.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe and discuss the EU GDPR changes that went into effect May 2018
- Apply the EU GDPR during the preparation of clinical trial documents, particularly the informed consent
- Disclose clinical trial data, using anonymization techniques compliant with the EU GDPR
Speaker(s)
Speaker
Larry Singer, JD, MBA, RPh
Syneos Health, Inc., United States
Senior Corporate Counsel & Deputy Global Data Protection Officer
Speaker
Lisa Zimmerman, MS
Axis Pharma, United States
President
Speaker
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery