Regulator Perspectives and Updates on Sharing Clinical Trial Documents and Data

On-campus seminar / live webcast – June 14 at 11 a.m. ET (60 min)

Presentation on the evolving landscape for sharing clinical trial data. This event is being organized in collaboration with Privacy Analytics.

There have been initiatives by various regulators around the world to share clinical trial information publicly. There are similarities in the approaches taken, but also some important differences. The purpose of this seminar is to provide an overview and update on these efforts from Health Canada and the FDA, both of which are initiating data transparency programs.

 

Health Canada Presentation

Title: Health Canada’s Guidance on the Public Release of Clinical Information

Speaker: Andre Molgat

Abstract:

Health Canada will provide an overview of its Public Release of Clinical Information initiative, including the regulatory proposal, implementation schedule, safeguards for the protection of commercially sensitive information, and approach to anonymization of patient data.

Andre Molgat is a Senior Regulatory Policy Adviser in the Health Products and Food Branch of Health Canada with scientific review responsibilities. He is a core member of the team responsible for Health Canada’s initiative on the Public Release of Clinical Information.

 

FDA Presentation

Title: FDA’s Clinical Summary Report (CSR) Disclosure Pilot

Speaker: Ann Witt

Abstract:

The FDA recently initiated a data transparency pilot project to release clinical summary reports publicly. Ann will present the pilot and lessons learned thus far.

Ann received her BA from Bryn Mawr College, and JD from Stanford Law School. After 1-year clerkship in the 9th Circuit Court of Appeals, she came to work at FDA in 1980 in the Office of Chief Counsel. Ann worked on new drug and device issues until 1991, and then spent a year heading the office responsible for overseeing prescription drug promotion. For the next 10 years, she worked in the Office of the Commissioner on issues including the tobacco investigation and the development pediatric testing requirements.  Beginning in 2002, she worked in the House of Representatives for Congressman Henry Waxman and the Energy and Commerce Committee, and returned to the FDA in 2009 and worked in the Office of the Commissioner on issues including transparency, drug safety, and modernization of FDA’s authority over cosmetics and OTC drugs. Ann recently began work in CDER’s Office of New Drugs, where she is working on the CSR Disclosure pilot among other projects.

 

Event Details

When: Thursday June 14th, 2018 at 11:00 (registration starts at 10:45)

Where: University of Ottawa, Louis-Pasteur Building (map), Room LPR-286

Agenda:

10:45am – 11:00am – Registration, coffee and pastries

11:00am – 11:05am – Opening remarks

11:05am – 11:30am – Health Canada presentation (incl. Q&A)

11:30am – 11:55 – FDA presentation (incl. Q&A)

11:55pm – 12:00pm – Closing remarks and general Q&A

Privacy Analytics is an Ottawa-based technology privacy company that provides solutions to de-identify health information, including clinical trial data and documents, to facilitate commercial and academic research and drug development.