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Session 3, Track A: HC/HTA Collaboration – Updates and Insights
Session Chair(s)
Louise Blythe, MS, MSc
VP & Head, Regulatory Affairs
Bayer Inc. Canada, Canada
Tharany Ganesh, MSc
Head, Regulatory Affairs
AstraZeneca Canada Inc., Canada
Time to patient access for Canadian medicines is a lengthy process. Pharmaceutical Regulatory Affairs professionals play a crucial role in this process. There have been recent initiatives undertaken to facilitate time to patient access for Canadian medicines via collaboration amongst industry, Health Canada, Health Technology Assessment agencies and government (policy makers). This session will provide updates and insights on the current initiatives and progress. This session will also address role of Regulatory Affairs in generating the value story and proactive ways to positively impact the process.
Learning Objective : - Understand progresses made on collaboration between Health Canada and Health Technology Assessment agencies and recent introduction of innovative approaches to facilitate access (eg, Real World Evidence and time-limited recommendation)
- Understand how these initiatives are being utilized by industry and the opportunities and challenges
- Understand Regulatory Affairs professionals’ role, contributions and opportunities to shape the Canadian reimbursement process
Speaker(s)
Health Canada and HTA Collaboration – A Multi-Faceted Partnership
Melissa Hunt, MSc
Health Canada, Canada
Director
Innovative Pathways to HTA
Matthew McDonald, PhD, MSc
Canada's Drug Agency, Canada
Director, Pharmaceutical Policy and HTA
Industry Perceptions and Experiences with HC/HTA Aligned Reviews
Emily Roome, JD
Innovative Medicines Canada, Canada
Director, Legal Services
The Role of the Regulatory Professional in HTAs
Myriam Antoun, MBA
PPD, Part of Thermo-Fisher Scientific, Canada
Global Head of FSP Regulatory Affairs
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