Regulatory Compliance for Dietary Supplements in the US EU and Canada
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:
Anyone wishing to successfully market dietary supplements in compliance with U.S. and Canadian regulations will greatly benefit from this seminar. A general overview of EU regulations will also be provided.
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.
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
Norma Skolnik has over 30 years of U.S. regulatory experience, starting in the drug industry. She was Associate Director of Regulatory Affairs at Lederle Laboratories and then became Assoc. Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum vitamins. When Lederle was acquired by Wyeth, she became Assoc. Director of Regulatory Affairs, there acquiring more experience in the Dietary Supplement and OTC drug fields. She joined Warner-Lambert Consumer Health division in 1998 and became Assistant Director of Regulatory for the Adams Division. In 2002 after Pfizer's takeover of Warner-Lambert, she was promoted to Director of Regulatory Affairs for the Adams Division. Adams was acquired by Cadbury-Schweppes in 2003 and she served as Cadbury Adams Director of Regulatory Affairs for the Americas from 2003 until her retirement in 2008. There she had responsibility for regulatory matters for all products marketed in North and South America.
Norma earned a Bachelor's degree in Biology from the University of Cincinnati and holds a Master's degree from Pratt Institute in New York. She's also done graduate work at Columbia University and Montclair State University.
Today Norma works as a regulatory consultant to FDA related companies and to firms who wish to launch products in the U.S.A. Her areas of expertise include OTC drugs and dietary supplements as well as assistance with product claims development and review of labelling and advertising.
Location: San Francisco CA
Date: 20th & 21st, February 2014
Time: 9 AM to 6 PM
Venue: Courtyard San Francisco Airport
Address: 1050 Bayhill Drive - San Bruno, California 94066 USA
Toll free: 1800 447 9407
Fax: 302 288 6884
NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
For More Info Click Here: http://bit.ly/1aX7REu
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