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Session 1 Plenary Session: New Era of Regulatory Affairs – Part I
Session Chair(s)
![Matthew Ryan](/_Images/member/Generic_Image_Missing-Profile.jpg)
Matthew Ryan
Senior Policy Analyst; Policy, Planning and International Affairs Directorate
Health Canada, Canada
With the passage of Bill C-17 (Vanessa’s law), the need for industry to enhance transparency of their review and evaluation of product safety profiles post launch is key. Similarly, regulators need to evaluate new data in a timely way to make critical decisions and take necessary actions. Many more changes in the pipeline such as anticipating drug shortages, a Consumer Product Framework, a new guidance for Subsequent Entry Biologics and Orphan Drugs share the need for increased transparency…all of which in turn are driving changes in how we do business, including processes, technical skills and people skills.
In this two-part plenary session, you will hear from a variety of stakeholders on how they are experiencing this new era and how they are responding to new requirements. Learn how their organizations are preparing themselves to comply with the new regulations in order to continuously improve the safety of medications and optimize the health care of Canadian patients.
Speaker(s)
![Heidi Jackson](/_Images/member/Generic_Image_Missing-Profile.jpg)
Regulatory Perspective on Openness and Transparency
Heidi Jackson
Health Canada, Canada
Director, Office of Transparency and Openness
![Andrew Casey](/_Images/member/Generic_Image_Missing-Profile.jpg)
Industry Perspective
Andrew Casey
BIOTECanada, Canada
President and Chief Executive Officer
![Katharina Kovacs-Burns, PhD, MSc](/_Images/member/Generic_Image_Missing-Profile.jpg)
Patient Organization Perspective
Katharina Kovacs-Burns, PhD, MSc
MHSA, Canada
Director Best Medicines Coalition
![Panel Q&A](/_Images/member/Generic_Image_Missing-Profile.jpg)
Panel Q&A
United States
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