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Session 6 Track A: International Collaboration via the Access Consortium: Health Canada and Industry Perspective
Session Chair(s)
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer
NoNO Inc, Canada
Mandy Collier
Director, Health Products and Food Branch
Health Canada, Canada
This session will focus on the Australia, Canada, Singapore, Switzerland and United Kingdom (Access) Consortium New Active Substance Work Sharing Initiative. Health Canada, on behalf of the Access Consortium regulatory partners, will share its experience and metrics to date, including perspectives on the strengths, challenges, and considerations for the future. The session will also include presentations on the industry’s perspectives. Innovative Medicines Canada (IMC) will share the findings of its survey of members’ experiences with submissions reviewed through this initiative. In addition, a specific case study will highlight the activities and timelines experienced by a company involved in the first Access Consortium four-way work-sharing initiative.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the goals of the Access Consortium New Active Substance Work Sharing Initiative (NASWSI) and its current status
- Understand the benefits, challenges and opportunities of participation in the NASWSI from a regulator’s perspective
- Gain awareness of the advantages, limitations and recommendations to enhance participation in the NASWSI from an industry perspective
Speaker(s)
Speaker
Jeffrey Skene, MSc
Health Canada, Canada
Director, Bureau of Cardiology, Allergy and Neurological Science
Innovative Industry’s Experience with ACCESS
Laura King, MBA
Innovative Medicines Canada, Canada
Vice Chair, Regulatory Operations Teams
The First ACCESS (Formerly Known as ACSS) Consortium Four-Way New Active Substance Work Sharing Initiative (NASWSI) Experience
Rose Mary Cianflone, MSc
Novartis Pharmaceuticals Canada Inc., Canada
Regulatory Affairs Specialist
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