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Session 4 Track A: Enhancing Innovation
Session Chair(s)
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
Executive Director, Scientific & Regulatory Affairs, Innovative Medicines Canada, Canada
Session Co-Chair
Kristen Beausoleil
Manager, Economic Analysis, Office of Legislative and Regulatory Modernization, Health Canada, Canada
Progress on Implementation of Vanessa’s Law to Date and Future Amendments
Loretta Del Bosco
Director, Regulatory Affairs Quality Assurance Operations, AbbVie Corporation, Canada
Supporting Innovation in the Regulatory landscape – thoughts from Innovative Medicine Canada
Stephanie Hardy, MPH, RAC
OPIC, Biologics and Genetic Therapies Directorate, HPFB, Health Canada, Canada
Supporting Innovation in the Regulatory Landscape - Possibiities Being Discussed via the Proposed Orphan Drugs Framework
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