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Session 6 Track 1 - New Frontiers: New Business Models
Session Chair(s)
Geoffrey Saroea, DrMed, MD
Senior Medical Affairs Advisor
Novartis Consumer Health Canada Inc, Canada
Chanez Narimene Kebache, MBA
Director, Global Product Safety & Pharmacovigilance
Canopy Growth Corporation, Canada
Drug development used to have a fairly predictable timeline and process. This is not true today. The increasing cost of drug development has spawned new business partnerships/mergers to help carry the cost and lower the burden and risk of failure. Indeed, drugs themselves are combined with devices and as well available in various patient selection tests. This session will review how industry and regulators are managing the regulatory complexities of these new development models. The speakers will provide insight from their experience in working through these new models and highlight key learnings.
Speaker(s)
Critical Path to Ensure Regulatory Compliance During Mergers and Acquisitions
Silvia Mamber, DrMed
Valeant Canada, Canada
Manager, Pharmacovigilance
Companion Diagnostics in Canada: Regulatory Considerations
Katherine M. Soltys, MD
Health Canada, Canada
Director, Office of Clinical Trials, Pharmaceutical Drug Directorate
Drug-Device Combinations - Regulatory and Other Considerations
Mary Speagle
TPI Reg a division of Innomar Strategies Inc., Canada
Senior Director, Regulatory Affairs
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