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Ottawa Marriott Hotel

17 oct 2017 7:00 a.m. - 18 oct 2017 3:00 p.m.

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Session 5A: Clinical Trial and Data Transparency

Session Chair(s)

Lorella  Garofalo, PhD

Lorella Garofalo, PhD

Head of Regulatory Sciences

Pfizer Canada, 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

Health Canada’s Regulatory Proposal and Policy on the Public Release of Clinical Information in Drug Submissions and Medical Device Applications

Andre Molgat, PhD

Health Canada, Canada

Head of Operations, Public Release of Clinical Information

Yolande  Dufresne

Legal Considerations with Disclosure of Clinical Data

Yolande Dufresne

TORYS, LLP, Canada

Refik  Saskin

Accessing Health Administrative Data Through ICES Data & Analytic Services

Refik Saskin

Institute for Clinical Evaluation Sciences (ICES), Canada

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