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Tuesday, June 16 • 9:30am - 10:30am
#211 L: Balancing Clinical Trial Disclosure and Transparency With Global Data Protection Regulations

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-639-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Robert Paarlberg, MS

Speaker

Legal Challenges in Balancing Data Transparency and Data Privacy Obligations
Michael A. DiMaio, JD

How Health Literacy Strategies Help Create Usable Clinical Trial Information for Patients
Catina O'Leary, PhD

Preparing Global Clinical Documents for Disclosure
Eileen Girten, MS



Speakers
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB... Read More →
avatar for Michael DiMaio

Michael DiMaio

Attorney, Ropes & Gray LLP
Michael DiMaio is an associate in the health care group at Ropes & Gray. He advises health care providers, pharmaceutical and medical device manufacturers, contract research organizations, and other health care organizations regarding a broad range of privacy, regulatory, compliance... Read More →
avatar for Catina O'Leary

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media (HLM)
Catina O’Leary, PhD, LMSW, is President & CEO of Health Literacy Media (HLM), a nonprofit health communications company located in Saint Louis, Missouri and working around the world. HLM provides training for health care providers in clear verbal and written health communication... Read More →
avatar for Eileen Girten

Eileen Girten

Director, Medical Writing, Pfizer Inc
Eileen M. Girten is Director of Medical Writing at Pfizer and is experienced in regulatory and publications writing, submissions, and mentoring. She is an Adjunct Assistant Professor at the University of the Sciences in Philadelphia and has taught Regulatory Documentation Processes... Read More →


Tuesday June 16, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session