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Session 6 Track 1 - New Frontiers: New Business Models

Track:
New Frontiers

Day & Time:
October 30, 10:30AM - 12:00PM

Type:
Session

Title:
Session 6 Track 1 - New Frontiers: New Business Models

Chair(s):
Geoffrey Saroea, DrMed
Senior Medical Affairs Advisor
Novartis Consumer Health Canada Inc, Canada

Chanez-Narimene Kebache
Manager, Pharmacovigilance
Mallinckrodt Pharmaceutical, Canada

Description:
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.

Presentation(s) & Speaker(s):
Critical Path to Ensure Regulatory Compliance During Mergers and Acquisitions
Silvia Mamber, DrMed
Manager, Pharmacovigilance
Valeant Canada, Canada

Companion Diagnostics in Canada: Regulatory Considerations
Katherine M. Soltys, MD
Manager, Oncology Division
Health Canada, Canada

Drug-Device Combinations - Regulatory and Other Considerations
Mary C. Speagle
Executive Director, Canadian Regulatory Affairs
OptumInsight, Canada

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