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Plenary Session 2: Stakeholder Perspective
Session Chair(s)
Chanez Narimene Kebache, MBA
Director, Global Product Safety & Pharmacovigilance
Canopy Growth Corporation, Canada
Matthew Ryan
Senior Policy Analyst; Policy, Planning and International Affairs Directorate
Health Canada, Canada
In today’s reality, companies are doing business internationally. While they are seeking to bring their products to global markets with unified research and development approach, they are facing national laws and diversified regulations and requirements in both the R&D phase as well as in the post approval surveillance and commercialization phase. After the regulator’s perspective, this plenary session will give an opportunity to industry representatives from different businesses to brief the audience on the involvement of stakeholders in the regulatory harmonization process, what are the challenges to face, the opportunities to focus on and how it may impact their future.
Speaker(s)
Regulatory Harmonisation – Industry Perspective
Peter Honig, MD, MPH, FACP
Advisor and Board Member, United States
International Regulatory Cooperation: Trends and Impacts for Academic SponsorsRegulart
Alison Urton
NCIC Clinical Trials Group, Canada
Investigational New Drug Program and Audit and Monitoring Group
A Survivor's Story
Norma Beauchamp
Patient Advocate, Canada
Breast and Thyroid Cancer Patient Experience Advocate
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