U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics 2019

Topics

• Understand how a serious adverse event is determined
• Understand adverse event reporting requirements for OTC drugs and dietary supplements
• Be able to implement FDA recordkeeping requirements
• Learn correct procedures for filing FDA notifications

Who should Attend

• Directors and associates
• Regulatory affairs managers
• Marketing managers
• Compliance specialists
• QA managers

• Understand adverse event reporting requirements for OTC drugs and dietary supplements
• Be able to implement FDA recordkeeping requirements
• Learn correct procedures for filing FDA notifications

The U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics 2019 intended for:

• Directors and associates
• Regulatory affairs managers
• Marketing managers
• Compliance specialists
• QA managers