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Overview: 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. Course Outline: Day 1 – Agenda Lecture 1: U.S. Dietary Supplement history & background: In depth look at the Dietary Supplement Health & Education Act and how FDA defines acceptable dietary supplements vs. those that aren't in compliance. 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. Day 2 – Agenda 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. 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. ABOUT SPEAKER – Norma Skolnik Senior Consultant, EAS Consulting 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. Location1: San Francisco CA 20th & 21st, February 2014 9:00 AM- 6:00PM Venue: Courtyard San Francisco Airport Price: $1,295.00 Discount: Register now and save $200. (Early Bird) Until January 05, Early Bird Price: $1,295.00 from January 06 to February18, Regular Price: $1,495.00 Address: - 1050 Bayhill Drive - San Bruno, California 94066 USA Location2: Atlantic City NJ 24th & 25th, April 2014 9:00 AM- 6:00PM Venue: Courtyard Washington Capitol Hill/Navy Yard Price: $1,295.00 Discount: Register now and save $200. (Early Bird) Until February15, Early Bird Price: $1,295.00 from February16 to April22, Regular Price: $1,495.00 Address: 1000 Boardwalk, Atlantic City, NJ 08401 Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php Event Link: http://bit.ly/JLaXBc NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
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