Title: The Importance of a Robust Adverse Event Reporting System
Date: Wednesday, October 29, 2014
Time: 2:00 PM Eastern / 11:00 AM Pacific Time
The What, When, Why and How of Serious Adverse Event Reporting
Serious Adverse Event Reports (SAERs) should be a major concern for dietary supplement companies as adverse events can happen at any time. SAER issues can be overwhelming for any business, but with the right system in place, there’s no need to fear.
Reporting and documenting serious adverse events in a timely manner for the Food and Drug Administration (FDA) is a necessity for the dietary supplement industry.
NPA’s standout webinar will provide you with all you need to know about reporting serious adverse events. Our experts will cover your regulatory responsibilities in the case of serious adverse events, including who has to report, how to record all adverse events, what constitutes a serious adverse event, the information needed by the FDA, and the consequences if you don’t report. They will also cover record-keeping responsibilities and questions you may be asked about complaint files from consumers during the Good Manufacturing Practices (GMP) inspection.
Daniel Fabricant Ph.D., NPA CEO and former Director of the FDA’s Division of Dietary Supplement Programs, was in charge of the policy group responsible for evaluating serious adverse event reports submitted to the agency for dietary supplements. Dr. Fabricant will share insider knowledge from the FDA’s standpoint, related to compliance for SAERs in the Federal Food Drug and Cosmetic Act and the importance of maintaining an Adverse Event Reporting database, as well as how to use that information to identify potential problems.
Rick Kingston, Pharm.D., President, Regulatory and Scientific Affairs for SafetyCall International, a noted expert in the field of adverse event reporting, will provide a full understanding of the requirements of SAER, share insight into where companies may be vulnerable, and discuss compliance concerns. He will also discuss the benefits and best practices of having a robust Adverse Event Reporting database in place. A Q & A session will take place at the end of the webinar to cover any remaining questions you may have on SAERs. You don’t want to miss out on this opportunity to hear from our experts on this timely topic!
Areas of discussion will include:
- What defines an adverse event and a serious adverse event
- Why reporting serious adverse events is essential to the industry
- Requirements for submitting serious adverse event reports
- How to receive, prepare and report a serious adverse event report
- Developing Standard Operating Procedures for adverse event reports and related documents and records
- How the FDA responds to adverse event reports and the regulatory consequences for not reporting
- Best practices related to documentation, management and regulatory reporting
- Best practices related to evaluating and conducting an analysis of your internal adverse event reports and post-market surveillance
This webinar is a must for anyone involved in receiving, investigating, documenting, reporting and/or responsible for adverse event reports and product complaints. This generally includes senior management, regulatory affairs, quality assurance/control and production personnel, and your legal department.
Don’t risk having your products seized or receiving an injunction or civil and/or criminal penalties for failing to report a serious adverse event.