FDA Adverse Event Reporting Rules: How It Applies to Drugs, Dietary Supplements & Cosmetics

Description

All OTC drugs and dietary supplements are required to report Serious Adverse Events (SAE) to the FDA. When the Personal Care Products Safety Act becomes law, cosmetic manufacturers will also have to report SAE to the FDA. It’s essential that companies understand how to define and report a Serious Adverse Event and what labeling and recordkeeping regulations are required under the Dietary Supplement & OTC Drug Consumer Protection Act.

This webinar by regulatory expert, Norma Skolnik will cover everything you need to know about how to define a serious adverse event and FDA’s SAE reporting requirements for OTC drugs, cosmetics and dietary supplements. It will also cover what to expect regarding reporting changes for cosmetics when the Personal Care Products Safety Act is passed.

Session Highlights:

• Background to FDA Serious Adverse Event reporting regulations
• How FDA defines a Serious Adverse Event
• Reporting for OTC drugs and dietary supplements
• Learn what products are covered and what changes are coming
• The importance of Medwatch reporting forms
• Specific SAE reporting and recordkeeping requirements and information
• Coming changes to cosmetics reporting with the Personal Care Products Safety Act

Also Includes:

• Live Q&A session with speaker
• PowerPoint presentation for download
• Certificate of attendance

Who Will Benefit:

• Regulatory affairs managers and associates
• Quality assurance managers
• Consumer affairs managers & representatives
• Marketing managers
• Safety managers
• OTC drug, dietary supplements and cosmetics companies
• Consumer healthcare or personal care companies