Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (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.All OTC drugs and Dietary Supplements are required to report Serious Adverse Events to FDA. When the Personal Care Products Safety Act becomes law, Cosmetics will also have to report Adverse Events to 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.Learning ObjectivesBackground to FDA Serious Adverse Event reporting regulationsUnderstand how to define a Serious Adverse EventLearn what products are covered and what changes are comingUnderstand specific SAE reporting and recordkeeping requirements and informationChanges that are coming for Cosmetics with the Personal Care Products Safety ActWho Should AttendRegulatory Affairs managers and associates at drug, Supplement, or Cosmetic firmsQuality Assurance managers at drug, Supplement, or Cosmetic firmsConsumer Affairs managers & representatives Marketing managers in Drug, Supplement, or Cosmetic industriesSafety managers
Single
This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (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.
All OTC drugs and Dietary Supplements are required to report Serious Adverse Events to FDA. When the Personal Care Products Safety Act becomes law, Cosmetics will also have to report Adverse Events to 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.
Learning Objectives
- Background to FDA Serious Adverse Event reporting regulations
- Understand how to define a Serious Adverse Event
- Learn what products are covered and what changes are coming
- Understand specific SAE reporting and recordkeeping requirements and information
- Changes that are coming for Cosmetics with the Personal Care Products Safety Act
Who Should Attend
- Regulatory Affairs managers and associates at drug, Supplement, or Cosmetic firms
- Quality Assurance managers at drug, Supplement, or Cosmetic firms
- Consumer Affairs managers & representatives
- Marketing managers in Drug, Supplement, or Cosmetic industries
- Safety managers
