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Mercure Hotel Amsterdam City

Dec 04, 2019 8:00 AM - Dec 05, 2019 5:00 PM

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 3: Health Canada and EMA Publication Policies

Session Chair(s)

Robert  Paarlberg, MS

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

Process Improvement

Scott Feiner

AbbVie, United States

Senior Manager, Trial Disclosure

Anne-Sophie  Henry-Eude, PharmD

Status of EMA Clinical Publication Policy

Anne-Sophie Henry-Eude, PharmD

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

Andre  Molgat, PhD

Health Canada and Their Publication Policy

Andre Molgat, PhD

Health Canada, Canada

Head of Operations, Public Release of Clinical Information

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