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Hilton Lac-Leamy

Nov 14, 2024 7:30 AM - Nov 15, 2024 4:10 PM

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

Canada Annual Meeting

The Canada Annual Meeting offers three tracks, Regulatory, Clinical, Safety and Pharmacovigilance!

Session 3, Track A: HC/HTA Collaboration – Updates and Insights

Session Chair(s)

Louise  Blythe, MS, MSc

Louise Blythe, MS, MSc

VP & Head, Regulatory Affairs

Bayer Inc. Canada, Canada

Tharany  Ganesh, MSc

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)

Melissa  Hunt, MSc

Health Canada and HTA Collaboration – A Multi-Faceted Partnership

Melissa Hunt, MSc

Health Canada, Canada

Director

Matthew  McDonald, PhD, MSc

Innovative Pathways to HTA

Matthew McDonald, PhD, MSc

Canada's Drug Agency, Canada

Director, Pharmaceutical Policy and HTA

Emily  Roome, JD

Industry Perceptions and Experiences with HC/HTA Aligned Reviews

Emily Roome, JD

Innovative Medicines Canada, Canada

Director, Legal Services

Myriam  Antoun, MBA

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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