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Session 4 Track A: Early Experience with Health Canada’s Clinical Information Disclosure Requirements
Session Chair(s)
Lorella Garofalo, PhD
Head of Regulatory Sciences, Pfizer Canada ULC, Canada
Health Canada implemented their Public Release of Clinical Information (PRCI) initiative this year and started to publically disclose anonymized clinical information from drug and medical device submissions on their online portal as of March 14, 2019. Regulations related to PRCI were published in Canada Gazette II on March 20, 2019, and a guidance document was issued on March 13, 2019. In this session PRCI requirements will be reviewed and early experience with these requirements from both a Health Canada and Industry perspective will be presented.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand Health Canada requirements for proactive and retroactive disclosure of anonymized clinical information from drug and medical device submissions
- Gain insight from Health Canada and Industry member perspectives on regulatory and operational challenges in the implementation of PRCI requirements
- Benefit by leveraging best practices from early experience with implementation of PRCI
Speaker(s)
Marcin Boruk, MBA, MSc
acting Director, Business Facilitation and Modernization Directorate, Health Can, Health Canada, Canada
Public Release of Clinical Information: Health Canada's Experience to Date
Louise Blythe, MSc
Head of Regulatory & Scientific Affairs, EMD Serono Canada, Canada
Industry Perspective and Lessons Learned – Navigating the Proactive Clinical Information Disclosure Process
Sabrina Moers, MSc
Director Regulatory Affairs, Merck & Co., Inc., Canada
Industry Perspective on the Implementation of PRCI
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