Dietary Supplements and OTC Drugs - Adverse Event Reporting
Date & Time: Tuesday, August 09, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Norma Skolnik
Price : $245.00
(for one participant)
Norma Skolnik Senior Consultant, EAS Consulting
Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will b e able to answer.
Why you should attend: There are often questions about what FDA considers to be an adverse event and about Adverse event reporting requirements for Dietary Supplements and OTC drugs. This Webinar will help to answer those questions and will help assure manufacturers and
importers that they comply with the law.
Areas Covered in the Session:
Adverse event reporting and recordkeeping requirements of the Dietary Supplement &Nonprescription Drug Consumer Protection Act Questions & Answers regarding the Labeling of Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Norma Skolnik has 30 years of regulatory experience in the OTC Drug, Food and Dietary Supplement industries. She has had extensive experience advising on regulatory strategies for new and marketed consumer healthcare products. Particularly regarding the development and review of optimal product claims and advertising. For 10 years, Norma served as Director of Regulatory Affairs for Cadbury Adams, Americas (formerly Adams Division of Pfizer). Previously she was Associate Director of Regulatory Affairs at Wyeth Consumer Healthcare and Associate Director, Regulatory Affairs at Lederle Consumer Health division of American Cyanamid....more
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Click here to register for this webinar Who Will Benefit:
Anyone who wants to market OTC drugs in the U.S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/webinar:
Regulatory Professionals Drug Marketers Manufacturers and Distributors
Students of FDA Regulations
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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