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Ottawa Marriott Hotel

Oct 27, 2015 8:30 AM - Oct 28, 2015 3:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting 2015

Session 1 Plenary Session: New Era of Regulatory Affairs – Part I

Session Chair(s)

Matthew  Ryan

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

Regulatory Perspective on Openness and Transparency

Heidi Jackson

Health Canada, Canada

Director, Office of Transparency and Openness

Andrew  Casey

Industry Perspective

Andrew Casey

BIOTECanada, Canada

President and Chief Executive Officer

Katharina  Kovacs-Burns, PhD, MSc

Patient Organization Perspective

Katharina Kovacs-Burns, PhD, MSc

MHSA, Canada

Director Best Medicines Coalition

Panel  Q&A

Panel Q&A

United States

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