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Course "Regulatory Compliance for Dietary Supplements in the US, EU and Canada"
has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
The course will cover basic regulatory requirements for marketing of dietary supplements in the U.S. and Canada including product safety, manufacturing, product claims, and labelling requirements. A general overview of EU regulations will also be given.
Why you should attend:
In order to successfully market dietary supplements in the U.S. and Canada, it's essential to understand and implement regulatory requirements for these regions. This 2 day seminar will help you understand these basic requirements to assure regulatory compliance necessary for product marketing.
Who Will Benefit:
- Executives of Dietary Supplement companies
- Regulatory Compliance Professionals
- Quality Assurance Professionals
- Dietary Supplement Manufacturers
- Dietary Supplement Distributors
- Sales/Marketing Personnel
For the U.S.: Key requirements for how dietary supplements are regulated including dietary supplement sale, marketing, manufacturing, labelling, claims, advertising and adverse event reporting. For Canada: NHP licensing and submission requirements, manufacturing requirements, site license requirements, labelling and consumer advertising of NHP products. EU: EU Regulatory framework, the EU Food Supplements Directive and the role of the EFSA will be covered in general.
Lecture 1: U.S. Dietary Supplement history & background: In depth look at the Dietary Supplement Health & Education Act and how FDA defines
Lecture 2: FDA requirements for Dietary Supplement Labeling and Adverse Event reporting. A thorough review of U.S. Dietary Supplement labeling compliance requirements with emphasis on Supplement Facts label regulations. Adverse Event reporting will also be covered.
Lecture 3: Dietary Supplement Claims & Advertising in the U.S. Covers different types of allowable dietary supplement claims and how to make the best claims in labeling and advertising without violating FDA regulations. Structure/Function claims will be covered in depth. FTC's role in regulating dietary supplement advertising will also be covered.
Lecture 4: Dietary Supplement Manufacturing GMPs in the U.S. How GMPs establish standards for identity, purity, strength and composition of dietary supplements and their component dietary ingredients. Specific GMP requirements for control, testing, and record keeping will be covered, as well as FDA facility registration requirements.
- acceptable dietary supplements vs. those that aren't in compliance.
Lecture 5: Canada's Natural Health Product (NHP) regulations: How they differ from U.S. regulations. Health Canada's NHP requirements and submission process will be covered. The role of Canada's Natural Health Products Directorate will be reviewed.
Lecture 6: Canadian NHP product licensing & site licensing requirements. What applicants need to obtain a Canadian license to market NHP products and the Health Canada approval process will be covered as will compliance with Canadian GMP regulations.
Lecture 7: Safety & Efficacy and labelling & advertising requirements for Canadian NHPs and how adverse events are handled. Canadian evidence requirements for safety and efficacy and NHP labelling requirements will be covered as well as Canadian health claim requirements and adverse event reporting.
Lecture 8: EU Dietary Supplement regulation and framework and EU Food Supplement Directive - a general overview. The EU Food Supplements Directive of 2002, which applies to vitamin & mineral supplements, will be covered. A general review of the EU Commission's harmonized rules for food supplements and the role of the EFSA will be given.
Location: Philadelphia, PA Hotel: Hilton Garden Inn Philadelphia Center City 1100 Arch Street, Philadelphia, Pennsylvania, 19107, USA