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Session 3: Health Canada and EMA Publication Policies
Session Chair(s)
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
Health Canada newly implemented its regulation on Public Release of Clinical Information. These new requirements covers both drug and device applications. As of 1 August 2018 EMA, suspended all new activities related to clinical data publication. This is a result of the implementation of the third phase of EMA's Business Continuity Plan. It is anticipated that EMA will resume publishing clinical data 4Q2019.
Learning Objective : At the conclusion of this session, participants should be able to: • Analyze and prepare for their organization’s process for the disclosure according to the Health Canada initiative. • Discuss EMA’s most current update on Policy 0070. • Share information on best practice to ensure the process will run as smooth as possible both for industry and regulators. • Discuss best practices in order to avoid double work when submitting clinical packges to Health Canada and EMA
Speaker(s)
Scott Feiner
Senior Manager, Trial Disclosure, AbbVie, United States
Process Improvement
Anne-Sophie Henry-Eude, PHARMD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
Status of EMA Clinical Publication Policy
Andre Molgat, PHD
Head of Operations, Public Release of Clinical Information, Health Canada, Canada
Health Canada and Their Publication Policy