This webinar will cover laws and regulations for Adverse Event Reporting of OTC Drugs, Dietary Supplements & Cosmetics in the U.S.A. The presentation will provide an understanding of FDA regulations to determine what are serious adverse events and how to report them properly. It will help the attendee understand current regulatory requirements for OTC Drug and Dietary Supplement adverse event reporting and what’s ahead for Cosmetic reporting in the U.S.A.
Objectives of Topic:
a. To gain an understanding of how FDA defines a Serious Adverse Event
b. To understand what FDA requires regarding Serious Adverse Event Reporting for OTC Drugs & Dietary Supplements;
c. to learn about FDA adverse event recordkeeping requirements;
d. To learn about the importance of Medwatch reporting forms
e. To understand what changes are coming for Cosmetic adverse event reporting under the Personal Care Products Safety Act.
Areas you will be Converd in the Session:
a. Background to the FDA Serious Adverse Event (SAE) Reporting regulations
b. What products are now covered and what changes are to be expected.
c. FDA definition of a serious adverse event and FDA adverse event labeling requirements
d. Specific AE reporting and recordkeeping requirements and Medwatch form submission.
who will benefit from your training.:
OTC Drug companies, Consumer Healthcare Product companies, Dietary Supplement firms and Cosmetic companies.
Norma Skolnik has over 35 years of U.S. regulatory experience, starting in the pharmaceutical industry. She was Associate Director of Regulatory Affairs at Lederle Laboratories in Pearl River, N.Y. and then became Associate Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum and Caltrate dietary supplements. When Lederle was acquired by Wyeth, she became Associate 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 Adams Regulatory Affairs. 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.
Norma earned a Bachelor’s degree in Biology from the University of Cincinnati and holds a Master’s degree from Pratt Institute in Brooklyn, New York. She’s also done graduate work at Columbia University and Montclair State University. Today Norma works as a regulatory consultant to FDA regulated companies and to firms who wish to launch products in the U.S.A.
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