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FDASIA Year in Review

Oct 24 2013 11:00AM - Oct 24 2013 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Daylight Time (EDT)


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.

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 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM - 8:00PM ET
CustomerService@diahome.org

Agenda and Event Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1 215.442.6199
Melissa.Buchanan@diahome.org

Event Logistics
Benjamin Zaitz, Event Planner
Phone +1.215.293.5803
Fax +1.215.442.6199
Benjamin.Zaitz@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; +1.703.506.3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 1 Elective Unit

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
FDASIA Year in Review IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Thursday, November 7, 2013.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits and Certificate Program Units are not available for participation in the archived version of the webinar.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org/CE

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.

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