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Ottawa Marriott Hotel

Oct 18, 2016 8:00 AM - Oct 19, 2016 4:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting 2016

Explore how innovation can support new initiatives, regulatory processes, research, transparency, engagement, personalized medicine, and use of real-world data in Canada.

Session 4 Track A: Enhancing Innovation

Session Chair(s)

Rocelyn  DelCarmen

Rocelyn DelCarmen

Director, Regulatory Affairs and Quality Assurance

Astrazeneca Canada Inc., Canada

Encouraging an environment in which innovation thrives is a priority for government and for industry alike. The regulatory processes that govern the conduct of business within the pharmaceutical sector must be aligned to achieve this goal, as well as being competitive with other similar jurisdictions to attract, retain, and deliver innovative health care solutions to the Canadian population. This session will discuss potential and upcoming changes to the Canadian regulatory framework to support faster access to new innovations. Health Canada and industry speakers will discuss options to close the gaps in the current regulatory framework and processes surrounding new product submissions to enable faster access to new therapies (e.g. Stop clock mechanism, introducing data during review, cost recovery and target timeline impact, use of external experts, and incorporating the patient perspective).

Speaker(s)

Keith  McIntosh

Session Co-Chair

Keith McIntosh

Innovative Medicines Canada, Canada

Executive Director, Scientific & Regulatory Affairs

Kristen  Beausoleil

Progress on Implementation of Vanessa’s Law to Date and Future Amendments

Kristen Beausoleil

Health Canada, Canada

Manager, Economic Analysis, Office of Legislative and Regulatory Modernization

Loretta  Del Bosco

Supporting Innovation in the Regulatory landscape – thoughts from Innovative Medicine Canada

Loretta Del Bosco

AbbVie Corporation, Canada

Director, Regulatory Affairs Quality Assurance Operations

Stephanie  Hardy, MPH, RAC

Supporting Innovation in the Regulatory Landscape - Possibiities Being Discussed via the Proposed Orphan Drugs Framework

Stephanie Hardy, MPH, RAC

Health Canada, Canada

OPIC, Biologics and Genetic Therapies Directorate, HPFB

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