Regulator Perspectives and Updates on Sharing Clinical Trial Documents and Data

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

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.

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

Networking, coffee and pasteries

11:00am – 11:30am – EMA presentation

An overview of the EMA clinical data publication and technical anonymisation group

Speakers: Anne-Sophie Henry-Eude and Monica Dias

11:30am – 12:00pm – Health Canada presentation

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

Speaker: Andre Molgat

12:00pm – 12:30pm – FDA presentation

FDA’s Clinical Summary Report (CSR) Disclosure Pilot

Speaker: Ann Witt

12:30pm – 01:00pm – Virtual panel / Q&A

General questions to guest speakers

EMA Presentation

Title: An overview of the EMA clinical data publication and technical anonymisation group

Speaker: Anne-Sophie Henry-Eude and Monica Dias

Abstract:

The EMA has been sharing clinical reports under its policy 0070 for almost 18 months. Much experience has been gained with respect to process and challenges. In this presentation we will provide an introduction to the clinical data publication effort at the EMA, statistics thus far on publications, some key lessons learned about anonymisation practices, and an overview of the activities and expectations from the technical anonymisation group.

About the speakers:

Anne-Sophie Henry-Eude graduated as Doctor in Pharmacy in 1999 at the University of Lille in France. She also has a post graduate in Pharmacovigilance & Pharmacoepidemiology as well as in Regulatory Affairs. After two years in the pharmaceutical industry where she worked in Regulatory Affairs and in the field of medical devices, Dr. Anne-Sophie Henry-Eude joined the anti-infectives and immunology team at EMA in 2001 where she worked on in particular referral procedures, pandemic influenza and infectious diseases. In 2011 she transferred to the EMA paediatric team to work especially on paediatric investigation plans to prevent and treat HIV in children. In 2013 Dr. Henry-Eude became the Head of the new Access to Documents Service at EMA and later on, with the implementation of Policy 0070 (Clinical Data Publication), the Head of Documents Access and Publication Service within the Office of the Deputy Executive Director.  Dr Henry-Eude is also a member of the EMA Technical Anonymisation Group (TAG).

Dr. Monica Dias studied pharmacy in Lisbon, Portugal and graduated with a Pharmacy graduate degree from the University of Lisbon in 1996. She proceeded to postgraduate studies and obtained her PhD from the University of Cardiff, UK. Her research focused on the permeation of drugs through the skin. Her postgraduate studies were funded by the Portuguese Ministry of Science and technology. She has several publications in Peer review journals. Dr. Dias joined Disperse Technologies Limited in Guildford, UK in 2000. She was involved in the research and development of a range of topical dosage forms. She joined the European Medicines Agency in London, UK in 2004. She worked in the Quality Office, Specialised Scientific Disciplines Department, for 10 years managing marketing authorisation applications and providing technical and scientific input to scientific advice procedures, paediatric investigation plans and referral procedures. In March 2013 she joined the Office of the Deputy Executive Director at EMA where she is now a Policy and Crisis Coordinating Officer. She was involved in the development and finalisation of Policy 0070 and continued with the implementation of this policy focusing on the data privacy aspects of the publication of clinical data. She led the development of the External guidance on the anonymisation of clinical reports for publication. Dr Dias is also the Chair of the EMA Technical Anonymisation Group (TAG).

 

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.

About the speaker:

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.

About the speaker:

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.

 

 

 

 

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.