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Session 8, Track A: Fostering Transparency: Health Canada, Industry, and Patient Perspectives on PRCI's Role
Session Chair(s)
Amber McLeod, PhD
Immunology, Virology, and Specialty Head, Regulatory Affairs, Abbvie Corporation, Canada
Marcia Sam
Senior Manager, Regulatory Affairs, Regeneron Canada Company, Canada
Increased transparency requirements, with the need to protect personal information and confidential business information (CBI) have posed challenges for both Sponsors and Regulators. In this session, we will discuss feedback from Health Canada on data anonymization and/or redaction and obstacles faced by Sponsors, share best practices and key considerations for the public release of clinical data (PRCI). We will also hear from an end user on how the data gathered from PRCI is used by patient associations/groups and the value that it brings.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain transparency requirements for Sponsors and what Regulators expect from PRCI submissions
- Discuss data anonymization/redaction challenges faced by both Sponsors and Regulators
- Share best practices and key considerations for public release of clinical data, during dossier preparation and post-approval
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Recognize the value of PRCI to relevant stakeholders
Speaker(s)
Etienne Thomas, MSc
Regulatory Affairs Specialist, Health Canada, Canada
Health Canada’s Public release of clinical Information (PRCI) and collaboration with EMA Policy 0070
Cathal Gallagher
Associate Director Clinical Transparency & Trial Disclosure, Regeneron, United Kingdom
Speaker
Julie Holtzople
Independent Consultant, Holtzople Consulting, United States
Driving Value in Clinical Trial Transparency Publications and Anonymization for Dummies