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Session 5 - Track B: New Technologies and Evolving Science as a Challenge to Regulatory Framework
Session Chair(s)
Matthew Ryan
Senior Policy Analyst; Policy, Planning and International Affairs Directorate
Health Canada, Canada
New technologies and evolving science are critical to the advancement of health care and treatment options for patients. Researchers, academia and the pharmaceutical industry have all played a significant role in bringing new drug and medical device technologies to market, leading to increased health benefits for Canadian patients. Even moreso today, scientific and technological advancements are being developed at a rapid pace, requiring effective support in order to advance from discovery, through development and into commercialization. Some of these advancements fit well into existing regulatory frameworks, while others present challenges and even potential barriers to what is needed in today’s environment. The regulator is also faced with challenges in using existing regulations in the application of science and technological advancements that could not have been foreseen even a few years. Speakers will present on these new challenges and how they are being addressed under today’s regulatory environment and how we need to re-think our approaches to these scientific and technical opportunities. While there are challenges, there are also opportunities for all areas of the pharmaceutical spectrum, including from both Industry and governments, to play a leadership role in facilitating science and regulation in the development of safe and effective drug therapies.
Speaker(s)
Overview of Health Canada's Initiatives in Tamper-Resistance and Abuse Deterrence
Kimby N. Barton, MSc
Health Canada, Canada
Interim Senior Executive Director, TPD
New Technologies and Evolving Science as an Opportunity for the Regulatory Framework
Barbara E. Tardiff, MD, MBA
Pfizer Inc, United States
Vice President, Development Operations
Overview of Canadian Guidance Documents on Rare Diseases
Agnes Klein, MD
Health Canada, Canada
Senior Medical Advisor
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