FDA vs. Health Canada Regulation of NHP and OTC Products

Product Id : FDA58
Instructor : Norma Skolnik
Oct 10, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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This webinar will provide an understanding of the key differences between U.S. FDA and Health Canada regulations for Consumer Healthcare products such as OTC drugs and Dietary Supplements/Natural Health Products.  This should enable companies who seek to market products in both countries to understand the different requirements that will enable them to market their products successfully in compliance with the regulations of each country.

The webinar will convey an understanding of the organizational oversight and differences between FDA and Health Canada regulation of OTC drug and Natural Health/Dietary Supplement products in the U.S. and Canada. 

This webinar will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.

Topics covered include: 

  • FDA vs. Health Canada organizational oversight for different product categories.  
  • Regulatory Submissions, filings and processes for different product types. 
  • Product Licensing & Registration Requirements. Health Canada Approval process vs. FDA approval requirements.     
  • Labeling and Advertising requirement differences between FDA vs. Health Canada.  
  • Consequences of Non-Compliance in Canada and the USA.

Who Will Benefit:

  • Regulatory Affairs managers and associates
  • Marketing managers
  • Quality Professionals
  • Product managers and Quality managers in the Consumer Healthcare, Drug, and Dietary Supplement industries who plan to market products in Canada and the USA.
Speaker Profile:

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare, as Associate Director of Marketed Product Support for Lederle Laboratories and as Associate Director of Regulatory Affairs for Wyeth.

Norma currently works as a regulatory consultant and also enjoys coaching those who are just starting out in the consulting field

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