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Interactions with the FDA During the IND/NDA Phases

Jul 23 2013 12:00PM - Jul 25 2013 1:00PM | Online

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Overview 

The purpose of this series is to provide the participants with information to allow appropriate contact with Agency personnel at various points in the IND/NDA phase.

Who Should Attend 

  • Regulatory affairs professionals new to the IND/NDA processes
  • Clinical development professionals
  • Biostatisticians
  • Basic researchers
  • Quality and manufacturing professionals
  • Medical writers
  • Business and marketing professionals
  • Clinical research academicians

Learning Objectives 

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

  • Apply formal meeting principles and practices when interacting with the FDA during the IND/NDA phases
  • List time course of events for sponsors in requesting a Type A, B, or C meeting with FDA

Special Offers 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions
Elizabeth Espich, Customer Service Associate
Phone +1.215.293.5802
Fax +1.215.442.6199
Elizabeth.Espich@diahome.org

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Faculty 

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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.

CERTIFICATE PROGRAMS
This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 2 Core Units

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

Continuing education credits are available to learners who participate in the live online training course.

Continuing education credits are not available for participation in the archived version of the online training course.

Name Credit Type Max Credits CEU
Interactions with the FDA IACET 2.00 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 each offering of the live online course 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 two weeks after the last day of the activity.

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

Continuing education credits are available to learners who participate in the live online training course. Continuing Education credits and Certificate Program units are not available for participation in the archived version of the online training course.

Agenda  

Day 1 Tuesday, July 23, 2013

  • 12:00PM - 1:00PM

    Part 1

Day 2 Thursday, July 25, 2013

  • 12:00PM - 1:00PM

    Part 2

Registration Fees 

Other Fees

Group Site
$1250.00

Member

Charitable Nonprofit/Academia Member Individual
$250.00
Member Government Individual
$250.00
Member Individual
$495.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$335.00
NonMember Government Individual
$335.00
NonMember Individual
$585.00
Group Discounts

GROUP SITE:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

This online training offering is sold as one complete series and cannot be purchased in parts.


Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course 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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