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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 B: New Technologies and Evolving Science as a Challenge to Regulatory Framework

Session Chair(s)

Matthew  Ryan

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)

Kimby N. Barton, MSc

Overview of Health Canada's Initiatives in Tamper-Resistance and Abuse Deterrence

Kimby N. Barton, MSc

Health Canada, Canada

Interim Senior Executive Director, TPD

Barbara E. Tardiff, MD, MBA

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

Agnes  Klein, MD

Overview of Canadian Guidance Documents on Rare Diseases

Agnes Klein, MD

Health Canada, Canada

Senior Medical Advisor

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