Click here to go to the previous page
International Regulatory Cooperation: A Canadian Perspective
Program Code:
237
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Agnes V. Klein MD is currently the Director, CERB in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in drug development and medical bioethics. SHe represents Canada at ICH and is member of several medical international orgnaizations
|
PRESENTER
(S):
Mike Ward is manager of the International Programs Division of the Therapeutic Products Directorate at Health Canada. He is also the Canadian Observer to the ICH Steering Committee and a former regulatory co-chair of the Global Cooperation Group
|
Nicholas Cappuccino, Pharmaceutical Intellectual Resource Services LLC, United States
Andrew Adams, Health Canada, Canada
Description
Health Canada has engaged in various forms of international cooperation over the years, from information sharing to harmonization and mutual recognition. This forum will look at current trends, drivers and opportunities for more effective cooperation and sort through the growing number of terms used to describe such activities. Specific examples will be presented as a basis for discussion, including the exploration of an international model for worksharing in the area of generic drug review.
Learning Objectives:
Discuss important new developments and drivers that are moving regulatory cooperation beyond information sharing to concrete, coordinated worksharing arrangements and how these events are shaping a new, global regulatory environment
Identify the growing number of terms and concepts used to characterize regulatory cooperation
Describe Health Canada's approach to more effective and strategic cooperation.