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Session 7 Track A: Implementation and Enforcement Approach for the Plain Language Labeling Regulations for Over-The-Counter (OTC) Drugs
Session Chair(s)
Kristin Willemsen, MS
Vice President, Scientific & Regulatory Affairs
Food, Health & Consumer Products of Canada, Canada
Robin Churchill, PhD, MSc
Director
Health Canada, Canada
It is crunch time. Sponsors of over-the-counter (OTC) drugs are diligently working to adapt over 2,000 marketed DINs and over ten thousand labels to adapt the Drug Facts Table and comply with the Plain Language Labelling Regulations before June 2021. This year, Health Canada has been receiving a record-breaking number of PLL related submissions in preparation for this compliance date. There is no time to waste for both industry and government. Gain tactical advice from Health Canada reviewers to help improve OTC PLL submissions, review outcomes and predictability. Learn how Health Canada applies a risk-based approach to compliance and enforcement by triaging complaints based on factors, identify priorities for enforcement, and determine risks to health in order to apply the enforcement tools to mitigate risks.
Learning Objective : At the conclusion of this session, participants should be able to:- Gain an appreciation for how Health Canada is managing OTC PLL submission volumes and review performance
- Recognize tactical tips and best practices about how to effectively prepare for and navigate the OTC PLL label review process
- Understand Health Canada’s overall approach to risk-based compliance and enforcement for OTC PLL
Speaker(s)
Speaker
Jason DiMuzio, MS
Health Canada, Canada
Label Review Coordinator, Non-Prescription Drugs Evaluation Division
Speaker
Representative Invited
Health Canada, Canada
Industry Perspectives on OTC PLL Implementation
Kristin Willemsen, MS
Food, Health & Consumer Products of Canada, Canada
Vice President, Scientific & Regulatory Affairs