Canadian Approaches to Regulatory Modernization and International Engagement

Track:
Global Regulatory

Day & Time:
June 26, 1:45PM - 3:15PM

Session Number:
361

Room Number:
203

Level:
Intermediate

Type:
Session

Title:
Canadian Approaches to Regulatory Modernization and International Engagement

Chair(s):
Agnes V. Klein, DrPH,MD
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
Health Canada, Canada

Description:
After several attempts at a major modernization via the Food and Drugs Act, it was decided in Health Canada to use the regulatory pathway to bring the regulations up to date without modifying the Food and Drugs Act itself. To that end, a new set of regulations for orphan drugs are being drafted. The approach that is used is novel, different, and unique as the regulatory framework; the needed guideline and the operational elements are being developed simultaneously and are informed by each other. In addition, the regulations will be a complete self-standing set which is intended to be a model for drug life cycle management. Health Canada has also adopted a number of postmarket ICH guidelines. Regulatory amendments are being drafted to allow Health Canada to request safety information on an ongoing basis from sponsors. In addition, in order to harmonize requirements, Health Canada has decided to consider the new PBRER as the format and content sufficient to fulfill Canadian requirements.

This session will also provide an overview of new developments on the clinical trial front with new directives, internationally, as well as the intended establishment of educational networks and networks of excellence that will facilitate global drug development.

Learning Objective(s):
Identify various regulatory approaches in different international jurisdictions; Discuss a broad brush overview of diverse ways regulations can be approached; Explain the participation of Canada in international endeavors that will facilitate and improve the development of therapeutics.

Presentation(s) & Speaker(s):
International Collaborations in Clinical Trials
Agnes V. Klein, DrPH,MD
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
Health Canada, Canada

Orphan Drugs Regulations and Framework
Marcin Boruk
Senior Policy Analyst
Health Canada, Canada

Update on the Adoption and Implementation of ICH E2C (R2): Periodic Benefit-risk Evaluation Reporting in Canada
Vicky Hogan, PhD,MSc
Director, Office of Risk Management and Science, Marketed Health Products Direct
Health Canada, Canada