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The Biosimilar User Fee Act: A Closer Look at the Fee Structure, Applications, and Meetings

Dec 6 2012 1:00PM - Dec 6 2012 2:30PM | Online

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Overview 

The Biosimilar User Fee Act of 2012 authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through September 2017. FDA dedicates these fees to expediting the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient.  BsUFA facilitates the development of safe and effective biosimilar products for the American public.

This webinar will provides an overview of the proposed user fee program, including biosimilar biological product development (BPD) fees, when BPD fees would be required, and the consequences of not paying fees. The proposed biosimilar biological product meeting types, goal dates, and procedures will also be reviewed.

Who Should Attend 

  • Pharmaceutical executives
  • Biomedical product developers
  • Regulatory affairs professionals
  • Clinical and nonclinical researchers
  • Biostatisticians and data managers

Learning Objectives 

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

  • Discuss BsUFA requirements and implementation plan
  • Describe the FDA’s plans to implement BsUFA
  • Define Biosimilar biological product development (BPD) fees, performance goals, meeting types, and procedurex

Contact Information 

Agenda Details and Event Details
Melissa Matta, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199
Melissa.Matta@diahome.org

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

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Continuing Education 

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.

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.

These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Unit each
• Regulatory Affairs Certificate Program: 1 Elective Unit each

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

Name Credit Type Max Credits CEU
The Biosimilar User Fee Act 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, & complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” & you will be prompted for your user ID & password. Select “My Transcript” (left side bar) & “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, December 20, 2012.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for the archived webinar.

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

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 and Group Plus registrations are available.

  • 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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