Adverse Event Reporting Requirements: IND and Postmarketing
This on demand training will take approximately 3 hours to complete.
Learn the basics of reporting adverse events to the FDA. This online training series will address the safety reporting regulations and provide you with tools to use in the submission process. The focus of this offering is on drugs and biologics. The safety reporting process for devices, generic products, or vaccines is not included in this series.
Course Level: Beginner
- Regulatory terms that determine how an adverse event is reported
- Guidances for safety reporting
- How to create IND safety reports (expedited reports)
- Reporting responsibilities – sponsor and investigator
- IND Annual Reports
- How to terminate an IND for safety
- How to create postmarketing safety reports
- 15 day
- Periodic safety reports
- How to create post-marketing safety reporting summaries
- Difference between NDA periodic safety reports and European periodic safety update reports
Who should attend?
Individuals new to the pharmaceutical industry or clinical research, including professionals involved in:
- Regulatory affairs
- Safety surveillance/pharmacovigilance
- Study and safety monitoring
- Clinical research
At the completion of this activity, participants should be able to:
- Define regulatory terms used in adverse event reporting
- Explain how an adverse event should be reported
- Discuss the requirements for expedited adverse event reports and annual (or periodic) adverse event reports
Ways to register
- Individual registration is a license for ONE internet login allowing one viewer.
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
Cancellations: No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs