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Tuesday, June 25 • 2:00pm - 3:15pm
#260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-612-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical study data is increasingly becoming available in the public domain. This session presents how the data is being utilized by patients and how sponsors are modifying their internal procedures to prepare disclosure-ready documents. Join the Clinical Trial Disclosure Community for a follow up Round Table discussion on Wednesday, June 26, 1:00-2:00PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Discuss how publicly available clinical data is being utilized by patient organizations; Describe approaches industry is taking to write clinical documents and provide clinical data for disclosure; Discuss Health Canada’s new regulation on publication of clinical trial information.

Chair

Robert Paarlberg, MS

Speaker

Overview of Health Canada’s Public Release of Clinical Information Initiative
Andre Molgat, PhD

Clinical Trial Disclosure and Transparency: An Industry Perspective
Liz Roberts, MSc

How Clinical Data is Being Used by Patients and Patient Organizations
Deborah E. Collyar



Speakers
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has applied a wealth of leadership skills from her successful IT business career to help create patient-centered medical research and healthcare, after her first cancer diagnosis at the age of 32. She founded Patient Advocates In Research (PAIR) in 1996, “where research... Read More →
AM

Andre Molgat

Senior Regulatory Affairs Advisor, Resource Management and Operations Directorat, Health Canada
André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training... Read More →
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the 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 created and directed global regulatory... Read More →
avatar for Liz Roberts

Liz Roberts

Global Public Policy Lead, External Engagement Practice, UCB Inc.
Liz is Senior Director and Global Public Policy Lead at UCB where she is responsible for establishing the strategic framework, guiding principles, and corporate policies that inform clinical trial transparency and responsible data sharing. She also leads other public policy priorities... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA