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Balancing Clinical Trial Disclosure and Transparency with Global Data Protection Regulations
Session Chair(s)
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
Global clinical trial disclosure requirements and initiatives result in extensive amounts of clinical data in the public domain. This session will discuss how the increasing transparency demands and competing privacy obligations are being addressed.
Learning Objective : Discuss the competing challenges of increasing demand to make more clinical data publicly available and data privacy obligations; Describe approaches industry is taking in preparing clinical documents for public disclosure to minimize risks of patient re-identification; Recognize patients’ concerns on disclosure risks.
Speaker(s)
Legal Challenges in Balancing Data Transparency and Data Privacy Obligations
Michael A. DiMaio, JD
Ropes & Gray LLP, United States
Attorney
How Health Literacy Strategies Help Create Usable Clinical Trial Information for Patients
Catina O'Leary, PHD
Health Literacy Media, United States
President and Chief Executive Officer
Preparing Global Clinical Documents for Disclosure
Eileen Girten, MS
Pfizer, United States
Medical Writing Therapeutic Area Lead