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Session 5 - Track A: Transforming Drug Safety and Surveillance
Session Chair(s)
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)
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
Implementing C17, Update and Next Steps-Health Canada Perspective
David K. Lee
Health Canada, Canada
Chief Regulatory Officer for Health Product and Food Branch
Implementing C17 Opportunities and Challenges - Industry Perspective
Keith McIntosh
Innovative Medicines Canada, Canada
Executive Director, Scientific & Regulatory Affairs
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