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Session 5A: Clinical Trial and Data Transparency
Session Chair(s)
Lorella Garofalo, PHD
Head of Regulatory Sciences, Pfizer Canada ULC, Canada
Increased transparency in research and regulatory decision making is a global growing trend. Regulatory authorities are adopting transparency policies that include requirements for disclosure of clinical trial information and data. In addition, research organizations have also implemented initiatives to make data more widely available. This session will provide an overview of Health Canada’s proposal to publicly release clinical information as well as the efforts undertaken by other groups to make data available to the broader research community. Implications for study participant confidentiality, compliance with privacy regulations in multiple jurisdictions and other legal considerations for data disclosure will also be discussed.
Speaker(s)
Andre Molgat, PHD
Head of Operations, Public Release of Clinical Information, Health Canada, Canada
Health Canada’s Regulatory Proposal and Policy on the Public Release of Clinical Information in Drug Submissions and Medical Device Applications
Yolande Dufresne
, TORYS, LLP, Canada
Legal Considerations with Disclosure of Clinical Data
Refik Saskin
, Institute for Clinical Evaluation Sciences (ICES), Canada
Accessing Health Administrative Data Through ICES Data & Analytic Services
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