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Session 3 Track A: International Collaboration and Approaches
Session Chair(s)
Melissa Hunt, MSc
Director
Health Canada, Canada
This session will focus on recent initiatives in the international collaboration. Specifically it will describe unique perspectives on the recent work-sharing pilot involving submission work-sharing with Australia and Canada as part of the ACSS (Australia-Canada-Switzerland-Singapore) work-sharing pilot. In addition, this session will include Health Canada’s collaboration with international regulators that are part of our work with the International Coalition of Medicines Regulatory Agencies (ICMRA). More specifically, the recently completed Innovation Project’s workstream on Novel Approaches to Licensing will be presented.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the realized and potential advantages to international work-sharing
- Understand the next steps around ACSS (Australia-Canada-Switzerland-Singapore) work-sharing initiative
- Understand the novel approaches other regulators are taking with respect to licensing
Speaker(s)
Industry Perspective on the Early Work-Sharing Pilots
Sandra Usik
Eli Lilly Canada Inc, Canada
Associate VP, Reg. Affairs, Quality & Compliance
International Worksharing and Collaboration
Kelly Robinson, MSc
Health Canada, Canada
Director General, Marketed Health Products Directorate
Novel Approaches to Licensing - An International Lens
Rong Sun, PhD
Health Canada, Canada
Associate Director with the Centre for Evaluation of Radiopharmaceuticals and Bi
Panelist
Jaigi P Mathai
Health Canada, Canada
Assessment Officer
Panelist
Kate Gurd, PhD
Health Canada, Canada
Senior Assessment Officer