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Session 2 Track 2B: Health Canada – Regulatory Transparency and Openness
Session Chair(s)
Stephanie Krupski
Consultant - Global Scientific Communications
Eli Lilly and Company, United States
During this session, we will discuss the new Health Canada policy on public release of clinical information. We will also explore how the Health Canada policy compares and contrasts to the EMA Policy 70. Finally, we will go over how companies/medical writers can proactively plan for Health Canada transparency requests.
Learning Objective : - Understand the goals/aims of the Health Canda policy on Public Release of Clinical Information
- Discuss the current state of the policy: How has the policy changed? What action groups are involved in defining the policy?
- Compare and contrast the Health Canada policy with/against the EMA Policy 70 on transparency
- Create action plan for medical writers to proactively prepare for the transparency requests
Speaker(s)
Speaker
Teresa Armstrong
Janssen, Pharmaceutical Companies of Johnson & Johnson, United States
Plain Language Summary Specialist
Speaker
Sandra Wainwright
Merck Canada Inc., Canada
Exec. Dir., Regulatory Liaison