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Practical Aspects and Examples of Using Large Datasets for Investigating Product Safety and Effectiveness in the US and EU

Nov 18 2013 11:00AM - Nov 18 2013 12:30PM | Online

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This webinar will be broadcast at 11:00 am-12:30 pm Eastern Time (ET)

Large health care datasets, for example: electronic medical records (EMRs) and claims data can provide meaningful information about medical product safety.  This webinar will discuss the practical aspects of using large datasets for evaluating product safety and effectiveness in both the US and EU.  Topics discussed during this webinar include the expertise and design needed to use the datasets, data privacy considerations, when a company would choose a method for safety issue validation, or evaluation, and the pros and cons over other safety monitoring methods.  Examples on how the use large health care datasets will be presented.

Featured Topics 

  • Using Large Datasets for Studying Product Safety and Effectiveness Using Electronic Health Records in the US
  • Landscape of Health Care Databases for Pharmacoepidemiology Research, with a Focus on Europe

Who Should Attend 

  • Clinical Safety / Pharmacovigilance
  • Clinical Research
  • Health Outcomes Research
  • Medical Affairs
  • Pharmacoepidemiology
  • Regulatory
  • Statistics

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Discuss the use of large health care datasets and the tools needed to obtain information about medical product safety
  • Identify the pros and cons of using these large datasets versus other safety monitoring methods
  • Discuss examples of the use of large health care datasets for studies of safety and effectiveness
  • Describe how to use large health care datasets for studying product safety and effectiveness using EMRs

Contact Information 

Registration Questions
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
Fax: +1.215.442.6199

Agenda Details
Colleen Braun, Content Lead
Phone +1.215.442.6160
Fax +1.215.442.6199

Event Logistics
JoAnn Boileau, Event Planner
Phone +1.215.442.6175
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.


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Continuing Education 

The 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; +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 .2 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: 1 Elective Unit
• Regulatory Affairs Certificate Program: 1 Elective Unit

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

Name Credit Type Max Credits CEU
Practical Aspects and Examples of Using Large Data IACET 1.50 0.200

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:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. 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 on Monday, December 2, 2013.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits and Certificate Program units are not available for participation in the archived version of the webinar.

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

Registration Fees 

Other Fees

Group Site
Group Plus


Member Government Individual
Member Academia Individual
Member Individual


NonMember Government Individual
NonMember Academia
NonMember Individual
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.

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.

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