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Thursday, November 6th, 2008, 11:00am – 1:00pm EST
From Registries to REMS, Measuring Safety, Minimizing Risk, and Meeting New Regulatory Requirements
Speaker for this event:
  • Richard Gliklich, MD, President, Outcome Learn More
  • From Registries to REMS, Measuring Safety, Minimizing Risk, and Meeting New Regulatory Requirements

    The expectations of regulators around signal detection, minimization of risk and evaluation of risk management programs have significantly changed over the last few years both in the U.S. and Europe.

     

    Punctuated by high profile product recalls and warnings, clear questions have been raised regarding the utility of the traditional approach to spontaneous adverse event reporting in meeting societal needs for safety monitoring.  This has translated into new expectations and, in some cases, new regulations, regarding the need for real-world data.  This has led to a significant change in the frequency and use of patient registries and other tools as part of post-approval commitments, RiskMAPs, and REMS. 

     

    This presentation will address the recent regulatory initiatives in the U.S. and Europe and how safety registries can effectively be used as part of a risk management, riskMAP, or REMS program strategy.  Dr. Gliklich will discuss the role registries and other tools have in this evolving area ranging from the evaluation of event rates, to controlling distribution in performance linked access systems to assessing REMS programs. Dr. Gliklich will also discuss good registry practices and considerations that will enable researchers to design and implement effective safety and benefit risk management registries.

     

    Learning Objectives

    • Understand the broad constructs of risk minimization and the recent regulatory risk management initiatives (including REMS) in the United States and Europe
    • Recognize the role safety registries can play, including active surveillance, and adverse event management of medical products
    • Use good registry practices in designing and implementing safety/surveillance and risk management programs
    • Identify how to evaluate and manage the data from these programs
    THIS PROGRAM IS INTENDED FOR:

    Within the Pharmaceutical, Medical Device, and Biotechnology industry:

    • Chief Executive Officers, Chief Scientific Officers, Chief Medical Officers

    • Vice Presidents, Directors, and Senior Managers of
      - Scientific Affairs                       - Epidemiology
      - Regulatory Affairs                     - Pharmacoeconomics
      - Product/Drug Safety                 - Pharmacovigiliance
      - Safety Surveillance                   - Risk Management
      - Health/Public Policy                 - Outsourcing
      - Health Economics                    - Clinical Affairs
      - Health Outcomes                     - Clinical Research
      - Outcomes Research                - Marketing

    REGION:  United States and Europe

    ABOUT OUR SPEAKERS:

    Richard Gliklich, MD, President, Outcome

    Dr. Richard Gliklich is President of Outcome, the leading provider for patient registries, studies, and technologies for evaluating real-world outcomes.

     

    Dr. Gliklich focuses on clinical research on the effectiveness, safety and quality of care.  Dr. Gliklich was principal investigator and senior editor of the landmark publication by the U.S. Agency for Healthcare Research and Quality (AHRQ) handbook “Registries for Evaluating Patient Outcomes: A User’s Guide.”  Some of the programs developed by Dr. Gliklich include the American Heart Association’s Get With The GuidelinesSM registries in cardiovascular disease, heart failure, and stroke, which involve more than 2,500 U.S. hospitals and more than one million patients, and received the 2004 Innovation Award from the U.S. Department of Health and Human Services and the 2007 eHealth Initiative Award.  

     

    Dr. Gliklich is a frequently invited speaker on post-approval programs and registries, and has served on numerous advisory boards.  He is the director of an annual international conference at Harvard, focusing on post-approval studies, registries and risk management (Post-Approval Summit®).  He has authored more than 90 academic publications, with a large number of articles on patient registries and patient reported outcomes.   Dr. Gliklich is the editor of a textbook on the practical value of real-world clinical data in medical practice, “Profiting from Quality:  Outcomes strategies for medical practice,” published by Jossey-Bass, Inc., in 1999.  He is a Principal Investigator (PI) for the Outcome DEcIDE Center, one of 13 DEcIDE centers under the Agency for Healthcare Research and Quality’s Effective Healthcare Program.  A graduate of Yale University and Harvard Medical School, Dr. Gliklich is also a former Charles A. Dana Scholar at the University of Pennsylvania School of Medicine in outcomes research.  In addition to his work at Outcome, Dr. Gliklich is a practicing physician and an Associate Professor at Harvard Medical School.

    ABOUT OUR SPONSORING PARTNER:

    Outcome is the leading provider of patient registries, studies, and integrated technologies for evaluating real-world outcomes.  Outcome provides services and technologies focused on evaluating the safety, effectiveness, and quality of healthcare products and services. The company has designed, developed, and managed more than 125 patient registries, including many of the largest and most well-recognized programs for disease outcomes, safety surveillance, and risk management. Outcome is an Agency for Healthcare Research and Quality (AHRQ) DEcIDE Research Center, a component of the “Effective Health Care” initiative sponsored by the U.S. Dept. of Health and Human Services.  Outcome was selected by the AHRQ to lead the effort to create the patient registries handbook “Registries for Evaluating Patient Outcomes: A User’s Guide,” released in May 2007. For more information please visit http://www.outcome.com/

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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