Drug Information Association Logo
Corporate Tagline

Utilizing the 505(b)(2) Pathway to Streamline and Accelerate a Drug Development Plan

Apr 18 2013 11:00AM - Apr 18 2013 12:30PM | Online

« Back to Listing

Overview 

In 2012, approximately 50 percent more products were approved through 505(b)(2) development compared to 505(b)(1) product approvals. The FDA’s 505(b)(2) approval pathway allows modification and repositioning of existing drugs or new chemical entities to provide products with improved safety and efficacy. However, you must understand the unique regulatory requirements and the best process to approach the FDA with your 505(b)(2) development plan. 

This webinar will illustrate how successful 505(b)(2) programs can be executed using preclinical studies to bridge to existing clinical data of an approved drug. The presentation will review currently approved 505(b)(2) drugs and the associated development plans that generated critical data to establish a nonclinical bridge between existing literature and data for the approved drug, as well as analytical and drug metabolism techniques that can be used for development.

In this webinar the presenter will highlight the following:

  • How metabolism studies can establish the appropriate species to build a toxicological bridge to existing data for an approved drug
  • How the dose response and equivalency of candidate products and the approved drug are evaluated
  • How a PIND meeting can be used to obtain FDA’s input regarding the appropriateness of the 505(b)(2) pathway and a proposed streamlined development plan

Who Should Attend 

Professionals involved in:

  • RD – Research & Development
  • RA – Regulatory Affairs
  • OS – Outsourcing
  • NC – Nonclinical
  • CP – Clinical Safety/Pharmacovigilance
  • CR – Clinical Research

Learning Objectives 

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

  • Identify potential candidates for 505(b)(2) drug development
  • Discuss process needed to obtain FDA input regarding the appropriateness of a 505(b)(2) development plan
  • Describe nonclinical, drug metabolism techniques that can establish equivalency and differences between a candidate to be approved via the 505(b)(2) pathway and a comparison product
  • Discuss the benefits that may be achieved through a 505(b)(2) submission

Contact Information 

Registration Questions
Vicki Adkinson, Customer Service Associate
Phone +1.215.442.6162
Fax +1-215.442.6199
Vicki.Adkinson@diahome.org

Agenda and Event Details
Colleen Braun, Content Lead
Phone +1.215.442.6160
Fax +1-215-442-6199
Colleen.Braun@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

Previous Next

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 webinar 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:
• Clinical Research Certificate Program: 1 Elective Unit
• Regulatory Affairs Certificate Program: 1 Elective Unit
For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Utilizing the 505(b)(2) Pathway 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, April 4, 2013.

Continuing education credits are available to learners who participate in the live webinar.

Continuing education credits and DIA's certificate program elective units are not available for the archived webinars.

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

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.

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.

« Back to Listing Back To Top