A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries.
This webinar with expert Norma Skolnik 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.
Session Highlights:
To understand how Natural Health Products (NHPs) are Defined by Health Canada
To learn about Product Licensing requirements and Health Canada approval process
To learn NHP Site License requirements
Learn the NHP Submission requirements
Advertising Guidelines for NHPs
U.S. FDA Dietary Supplement Regulatory Requirements
How U.S. Dietary Supplement Regulations differ from Canada’s
Why Should You Attend?
Get an overview of what Health Canada considers to be a Natural Health product and review Canadian regulations for Natural Health Products
A comparison is shown between Canadian requirements with U.S. FDA requirements for marketing dietary supplements and convey an understanding of how they differ
References to all relevant Health Canada NHP regulations, FDA regulations, guidance documents and FDA websites will be provided along with regulatory know-how tips
Who Should Attend
Regulatory Affairs Managers and Directors
- Directors & Associates
Product Safety Managers
Compliance Specialists
Marketing Managers
Senior Applications Scientists
Quality Coordinators
Business Development Managers in Packaging Industries
- Anyone involved in planning to market or label dietary supplement/NHP products in the U.S. or Canada
Norma Skolnik
Norma Skolnik is currently a Regulatory Consultant with over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She was Director of Regulatory Affairs for the Americas for Cadbury Adams and Director of Regulatory Affairs for the Adams division of Pfizer before that. Prior to that she was Associate Director of Regulatory Affairs for the Warner-Lambert company and Associate Director Regulatory Affairs at American Home Products Whitehall-Robbins Division.
Health Canada's Regulations on NHP vs U.S. Dietary Supplement
The webinar discussed valuable information for NHP licensing. I would like to see a similar webinar for DEL Licensing in the future
Thanks
by Firas Alkhyaat, Menasha Packaging Canada LLC