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Overview

Continuing Education Credits are not available for the archived offering.
This program is a part of DIA's Certificate Program and is awarded the following:
Clinical Safety & Pharmacovigilance Certificate Program: 3 Elective Units
Regulatory Affairs Certificate Program: 3 Elective Units
For more information go to www.diaglobal.org/certificateprograms

This archive may be purchased through July 23, 2015.
Archive duration:
Part 1: 1 hour 3 minutes
Part 2: 1 hour 1 minute
Part 3: 48 minutes


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

Featured topics

  • 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

Learning objectives

At the conclusion 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

Contact us

 Printable Registration Form

Registration Questions and
Technical Support
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Ways to register

 Printable Registration Form

  • 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