Back to Agenda
Session 3 - Track A: Communications with Regulators and Among Industry
Session Chair(s)
Vratislav Hadrava, MD, PhD
Vice President and Medical Director, Global Innovative Products
Pfizer Canada, Inc., Canada
Good communication between industry and regulators is a cornerstone of predictable process and outcome in review and regulatory decision making of all regulatory files as well as in consultation on new or updating regulations, guidances and policies. The session will primarily provide overview of key principles and challenges during the first cycle review in Canada and US with reflection on possible evolution and improvements. It will be complemented by learnings from Health Canada effective risk communication needs, planning and process.
Speaker(s)
Agency and Industry Perspectives on FDA Regulatory Review Transparency and Communication
Jayne Ware, MPH, MSc
Merck Sharp & Dohme LLC , United States
Senior Director, Global Regulatory Policy
Communications with Regulators and within Industry
Loretta Del Bosco
AbbVie Corporation, Canada
Director, Regulatory Affairs Quality Assurance Operations
Risk Management Planning in Canada
Matthew Bown
Natural and Non-Prescription Products Directorate, Canada
Senior Policy Advisor
Have an account?