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Adverse Event Reporting Requirements: IND and Postmarketing

Jul 22 2014 12:00PM - Jul 24 2014 1:30PM | Online

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This online training will be broadcast in Eastern Time (ET)

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

Special Offers 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions and
Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET


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Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 2210,+1.703.506.3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .5 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 3 Elective Units:
• Regulatory Affairs Certificate Program: 3 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Adverse Event Reporting Requirements: IND and Post IACET 4.50 0.500

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

Continuing education credits are available to learners who participate in the live online training course. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests two weeks after the last day of the activity.

Continuing education credits are available to learners who participate in the live online training course. Continuing education credits are not available for participation in the archived version of the online training course.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE


Day 1 Tuesday, Jul 22, 2014

  • 12:00PM - 1:30PM

    Part 1: IND Reporting Requirements

Day 2 Wednesday, Jul 23, 2014

  • 12:00PM - 1:30PM

    Part 2: Workshop Review and Postmarketing Adverse Event Reporting

Day 3 Thursday, Jul 24, 2014

  • 12:00PM - 1:30PM

    Part 3: Postmarketing Adverse Event Reporting: Periodic Reports

Registration Fees 

Other Fees

Group Site


Charitable Nonprofit/Academia Member Individual
Member Government Individual
Member Standard Individual


Charitable Nonprofit/Academia Nonmember Individual
NonMember Government Individual
NonMember Standard Individual
Group Discounts

Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

This online training offering is sold as one complete series and cannot be purchased in parts.

Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course 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.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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