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

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Continuing Education credit or Certificate Program units are not available for Archived Webinars

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.

This Archived Webinar will be available until May 31, 2014

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

Questions on Archived Webinar
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.


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Day 1 Wednesday, November 20, 2013

  • 7:00AM - 11:59PM

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

    Session Chair(s):

    • Mary Mease, MPH,RPh
      Senior Director, Benefit-Risk Management, Safety Knowledge and Reporting
      Quintiles Inc., United States


    • Using Electronic Data for Research and Quality Assessment
      Suzanne West
      Fellow and Senior Scientist, Social Policy, Health & Economics Research
      RTI International, United States
    • Using Electronic Health Data
      Nancy A. Dreyer, PhD,MPH,FISPE
      Global Chief of Scientific Affairs, Real-World and Late Phase Research
      Quintiles Outcome, United States
    • Large Health Care Databases for Safety and Effectiveness Research With Focus on Europe
      Susana Perez-Gutthann, MD,PhD,MPH,FISPE,FRCP
      Vice President, Global Head Epidemiology
      RTI Health Solutions, Spain

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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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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