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A Closer Look at FDASIA Provisions to Promote Biomedical Innovation

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Overview 

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


The Food and Drug Administration Safety and Innovation Act (FDASIA) provides FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilars.  FDASIA also includes a number of significant new provisions to promote the development and availability of safe, effective, and innovative therapies, including:

  • Expansion and modernization of the accelerated approval process
  • Provision of a new pathway for “breakthrough” therapies
  • Incentives for antibiotic development
  • Enhanced communication during drug development under PDUFA
  • The New Molecular Entity (NME) review process
  • Structured approaches to Benefit-risk assessment

This webinar will cover these topics, as well as the recently proposed Special Medical Use pathway, and provide opportunity for discussion of FDA’s expedited approval mechanisms.

This webinar is an initiative from the DIA Regulatory Affairs Community


Archived Webinar is available for purchase through May 1, 2014

Who Should Attend 

  • Regulatory affairs/Operations
  • Clinical safety/Pharmacovigilance (pre and post-market)
  • Data standards/Data management
  • Electronic submissions
  • Nonclinical and early phase development

Learning Objectives 

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

  • Discuss the Food and Drug Administration Safety and Innovation Act (FDASIA) user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilars
  • Identify and describe the new provisions under FDASIA to promote the development and availability of safe, effective, and innovative therapies

Contact Information 

Questions on Archived Webinar
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Wednesday, May 01, 2013

  • 7:00AM - 11:59PM

    A Closer Look at FDASIA Provisions to Promote Biomedical Innovation

    Speaker(s):

    • Kay Holcombe, MS
      Vice President, Senior Policy Advisor
      Genzyme - a Sanofi Company, United States
    • A Closer Look at FDASIA - Provisions to Promote Biomedical Innovation
      Andrew Emmett, MPH
      Managing Director, Science and Regulatory Affairs
      The Biotechnology Industry Organization (BIO), United States

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Individual
$250.00

Non-Member

NonMember Individual
$295.00
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.


CANCELLATIONS
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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