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Adverse Event Reporting Requirements: IND and Postmarketing

Jul 30 2013 12:00PM - Aug 1 2013 1:30PM | Online

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Overview 

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 and not the safety reporting process for devices, generic products, or vaccines.

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 online training, 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
Marilyn Ginsberg, Customer Service Associate
Phone +1.215.442.6135
Fax +1.215.442.6199
Marilyn.Ginsberg@diahome.org

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

Technical Requirements 

Click here for minimum system requirements.

Faculty 

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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 22102 (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.

These programs are part of DIA’s Certificate Program and are 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 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 activity. Participants must attend the entire live online training activity in order to be eligible to receive a statement of credit. No partial credit will be awarded. 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 and DIA’s Certificate Program units 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

Agenda  

Day 1 Tuesday, July 30, 2013

  • 12:00PM - 1:30PM

    Part 1: IND Reporting Requirements

Day 2 Wednesday, July 31, 2013

  • 12:00PM - 1:30PM

    Part 2: Workshop Review and Post-Marketing Adverse Reporting

Day 3 Thursday, August 01, 2013

  • 12:00PM - 1:30PM

    Part 3: Post-Marketing Adverse Event Reporting: Periodic Reports

Registration Fees 

Other Fees

Group Site
$1750.00

Member

Charitable Nonprofit/Academia Member Individual
$350.00
Member Government Individual
$350.00
Member Individual
$695.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$435.00
NonMember Government Individual
$435.00
NonMember Individual
$785.00
Group Discounts

GROUP SITE:
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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