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FDASIA Year in Review

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Overview 

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


Enacted just over a year ago, the Food and Drug Administration Safety and Innovation Act (FDASIA) reauthorizes the Prescription Drug User Fee Act (PDUFA) and expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health by: 

  • Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; 
  • Promoting innovation to speed patient access to safe and effective products;
  • Increasing stakeholder involvement in FDA processes; and
  • Enhancing the safety of the drug supply chain.

This webinar will focus on the progress of the PDUFA V and initiatives to promote innovation and speed to patient access. Topics include:

  • User fee levels: User fees were increased to provide improvements to the FDA regulatory review processes. Sequestration in FY 2013 limited FDA and NIH from accessing nearly $83 million in industry-paid user fees. Will FY 2014 be the same?
  • Perspective on the new molecular entity review process: Has it increased the efficiency and effectiveness of the first review cycle of a new medicine?
  • Status update on benefit-risk assessment activities
  • FDA’s interpretation of the fast track, breakthrough therapy, accelerated approval, and priority review programs: The breakthrough therapy designation for drugs was established to offer improvement over available therapies for patients with serious or life-threatening diseases. FDA published guidance its expedited programs.

Join this webinar to hear what FDASIA has given us this past year – and what we might expect in the coming year.


Archived Webinar available through April 30, 2014

Who Should Attend 

This webinar is designed for professionals involved in:

  • Compliance activities for pharmaceutical, medical device, and biologics manufacturers
  • Regulatory affairs
  • Clinical safety

Learning Objectives 

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

  • Describe the FDASIA provisions that have been implemented in the past year
  • Discuss some of the FDASIA milestones that have been met in the past year

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 Friday, October 25, 2013

  • 7:00AM - 11:59AM

    FDASIA Year in Review

    Speaker(s):

    • FDA Safety and Innovation Act (FDASIA), Government Shutdown and Sequestration
      Kimberly Belsky, MS
      Executive Director, Advertising, Labeling and Policy
      Valeant Pharmaceuticals , United States
    • Lisa Jenkins
      Virtual Regulatory Solutions Inc., United States
    • Ronald I. Trust, PhD,MBA
      Executive Director, Regulatory Affairs
      Durata Therapeutics, Inc., United States

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$995.00

Member

Member Government Individual
$125.00
Member Academia Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
NonMember Academia Individual
$175.00
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.

Register Online

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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