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Ottawa Marriott Hotel

Oct 28, 2014 8:00 AM - Oct 29, 2014 3:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA’s Annual Canadian Meeting: Thinking Globally, Acting Locally for The Well-Being of the Patient

Session 5 - Track A: Transforming Drug Safety and Surveillance

Session Chair(s)

Rocelyn  DelCarmen

Rocelyn DelCarmen

Director, Regulatory Affairs and Quality Assurance

Astrazeneca Canada Inc., Canada

Learning Objective : 1. To outline the current Canadian regulatory framework for the safety monitoring of human cells, tissues and organs (CTO) used in transplantation, including the challenges and limitations. 2. To share insight into enhancement initiatives being undertaken by Health Canada to improve the CTO surveillance system in Canada.

Speaker(s)

Mélanie  Derry, PhD

Continuous Improvement Efforts by Health Canada to Enhance the Human Cells, Tissues and Organs Surveillance System in Canada

Mélanie Derry, PhD

Health Canada, Canada

Associate Director

David K. Lee

Implementing C17, Update and Next Steps-Health Canada Perspective

David K. Lee

Health Canada, Canada

Chief Regulatory Officer for Health Product and Food Branch

Keith  McIntosh

Implementing C17 Opportunities and Challenges - Industry Perspective

Keith McIntosh

Innovative Medicines Canada, Canada

Executive Director, Scientific & Regulatory Affairs

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