U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.

Why Should You Attend:

This webinar will cover requirements for all manufacturers, packers, or distributors whose name appears on a drug or dietary supplement product label for adverse event reporting. The program will also include discussions on FDA notification requirements, determination of what constitutes a serious adverse event, procedures for filing reports, and record keeping requirements.

Who Will Benefit:

Regulatory affairs managers

Directors and associates

Compliance specialists

Marketing managers

QA managers

Instructor Profile:

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as director of regulatory affairs for the Americas for Cadbury Adams. Prior to that she was director of regulatory affairs for the Adams Division of Pfizer and associate director of regulatory affairs for the Warner-Lambert company.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2016.

For Registration:

http://www.complianceonline.com/us-adverse-event-reporting-regulations-for-drugs-dietary-supplements-and-cosmetics-webinar-training-704371-prdw?channel=sciencedz