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Implementation of the FDASIA Patient Provisions

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Overview 

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This archive will be available for purchase through February 28, 2015
Broadcast time: 1 hour 30 minutes


FDA has a long history of including the patient perspective through the FDA Patient Representative Program, where patients have been mainly included on Advisory Committees. The Food and Drug Administration Safety and Innovation Act (FDASIA) included multiple provisions to increase the inclusion of the patient perspective in FDA's decision-making.  This webinar will provide an overview of these new programs, and get an update on their implementation. Both Section 1137 of FDASIA and the Patient Focused Drug Development commitment in PDUFA V have moved to include the patient perspective earlier in regulatory discussions with industry. The session will provide a brief historical introduction, followed by a high-level overview of these new patient provisions. The FDA staff responsible for implementing these provisions will provide a detailed update on their progress and share their vision for the evolving role of patient advocacy in regulatory decision-making. A patient advocate will provide their views on FDA's progress in implementing these provisions, as well as the role that the patient advocacy community can play as partners in these initiatives.

Featured Topics 

  • FDASIA
  • Patient Representatives
  • Patient Focused Drug Development

Who Should Attend 

  • Industry patient engagement professionals
  • Patient advocates
  • Regulators interested in enhancing patient input

Learning Objectives 

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

  • Discuss the FDASIA enhancements to FDA’s patient advocacy programs 
  • Describe FDA’s progress and vision in implementing the various patient provisions
  • Identify opportunities for external stakeholders to engage with FDA’s patient advocacy programs

Contact Information 

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Carolyn Callahan
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Presenter(s) 

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Agenda  

Day 1 Wednesday, Mar 05, 2014

  • 11:00AM - 11:59PM

    Implementation of the FDASIA Patient Provisions

    Speaker(s):

    • FDASIA Section 1137 “Patient Provision”: Implementation Update
      James E. Valentine, JD
      Associate
      Hyman, Phelps & McNamara, P.C., United States
    • Implementation of the FDASIA Patient Provisions: Patient Engagement in Drug Regulation
      John J. Whyte, MD, MPH
      Director, Professional Affairs and Stakeholder Engagement, OCD, CDER
      FDA, United States
    • Patient-Focused Drug Development
      Sara L. Eggers
      Operations Research Analyst, Office of Program and Strategic Analysis, CDER
      FDA, United States
    • Patient-Focused Drug Development
      Marc M. Boutin, JD
      Executive Vice President and Chief Operating Officer
      National Health Council, United States

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Registration Information

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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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