Description:
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.
For More Details:-https://www.grcts.com/GRC-90044
