Health Canada Regulation of Natural Health Products vs. U.S. Dietary Supplement Regulations

Product Id : FDA102
Instructor : Norma Skolnik
Apr 26, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Get an Understanding of How Canadian Requirements Differ From U.S. FDA Requirements for Marketing/Labeling Dietary Supplements

This event by expert Norma Skolnik will offer an overview of what Health Canada considers to be a Natural Health product and review Canadian regulations for Natural Health Products. It will compare Canadian requirements with U.S. FDA requirements for marketing dietary supplements and convey an understanding of how they different.

Plus, get references to all relevant regulations, both Health Canada NHP regulations and FDA regulations, as well as references to guidance documents and websites. You will come away from this session with useful regulatory knowledge and know-how for compliance.

Why Should You Attend:

This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

Learning Objectives:

  • How Natural Health Products (NHPs) are Defined by Health Canada
  • Product Licensing requirements and Health Canada approval process
  • NHP Site License requirements
  • NHP Submission requirements
  • Advertising Guidelines for NHPs
  • U.S. FDA Dietary Supplement Regulatory Requirements
  • How U.S. Dietary Supplement Regulations differ from Canada’s

Areas Covered in the Webinar:

  • FDA vs. Health Canada – Organizational Oversight for Different Product Types
  • FDA vs. Health Canada – Regulatory Submissions / Filings and / or Regulatory Processes for Different Product Types
  • FDA vs. Health Canada – Quality Systems & Establishment Licensing, Requirements for Supply Chain Entities
  • Examples of Consequences for Non-Compliance with Regulatory Authorities
  • FDA & Health Canada – Interactions & Potential Implications for industry

Who Should Attend:

  • Regulatory Affairs managers/Director
  • Directors & Associates
  • Product Safety managers
  • Quality Professionals
  • Compliance Specialists
  • Anyone involved in product safety or planning to market or label dietary supplements/ Natural Health Products in Canada or the U.S.A.
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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