Understanding EMA Policy 0070 and Health Canada PRCI Transparency Requirements

This Expert Insights webinar will focus on key elements of current transparency regulations, including the background and history of the European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI) requirements for the publication of clinical trial data. Key requirements of both health authorities will be discussed in-depth, including similarities and differences. Additionally, attendees will learn about the future of document sharing and what will be required to disclose publicly in the years to come.

Attendees will learn:

-Key requirements for EMA Policy 0070,
-Key requirements for Health Canada PRCI,
-Similarities and differences between EMA Policy 0070 and Health Canada PRCI,
-Additional avenues for sharing documents, and
-The future of clinical document sharing, including technologies to aid in this process

Presenters:

Kelly Vaillant, Director, Global Transparency Strategy & Compliance
Kavita Verma, Senior Transparency Lead
Megan Niner, Transparency Specialist

This is the first part of a two-part series. The second webinar will focus on strategies for ensuring success in implementing EMA Policy 0070 and Health Canada PRCI.

This webinar was sponsored by MMS Holdings (award-winning, data-focused clinical research organization) and TrialAssure (a leading clinical trial disclosure and clinical trial data transparency suite).