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Regulatory Affairs: The IND, NDA, and Postmarketing

Nov 11 2013 8:00AM - Nov 14 2013 4:45PM | Loews Philadelphia Hotel 1200 Market St, Philadelphia, PA 19107-3615 USA

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Overview 

Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of lectures, workshops and online precourse modules.

What You Will Learn 

  • Fundamentals of the Investigational New Drug and New Drug Application Processes
    • Preparation
    • Content
    • Strategy
  • Meetings and other interactions with FDA
  • Postmarketing Requirements
  • Labeling and Advertising

Who Should Attend 

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

Learning Objectives 

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

  • Explain the importance of incorporating regulatory strategy into the drug development plan
  • Recognize content and format requirements for IND/NDA in the Common Technical Document Format
  • Plan and prepare an IND/NDA, and know the reporting requirements for IND/NDA amendments
  • Identify FDA review processes for evaluating IND/NDAs
  • Define NDA post-approval responsibilities and requirements
  • Identify regulatory mechanisms to facilitate development of new therapies
  • Report adverse events in accordance with current FDA  regulations 
  • Apply formal meeting principles and practices when interacting with the FDA during the IND/NDA phase
  • Outline the regulatory requirements for prescription drug labeling and advertising/promotion

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Loews Philadelphia Hotel
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until October 27, 2013, or until room block is filled). Attendees should make airline and room reservations as soon as possible.
Address: 1200 Market Street, Philadelphia, PA 19107
Phone: +1-215-627-1200
Toll Free: +1-888-575-6397

Standard Room Rate

$199

When making reservations, mention the DIA training course.

Click here for Loews Philadelphia Hotel.

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

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; +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 3.0 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

These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Research Certificate Program: 16 Elective Units each

•Project Management Certificate Program: 8 Elective Units each

• Regulatory Affairs Certificate Program: 16 Core Units each

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

Name Credit Type Max Credits CEU
Regulatory Affairs: The IND, NDA, and Postmarketin IACET 29.50 3.000

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 attend the course, sign-in at the DIA registration desk each day of the course, and complete the on-line 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 two weeks after the last day of the course.

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

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$1715.00
Member Government
$1715.00
Member Standard
$3120.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1940.00
NonMember Government
$1940.00
NonMember Standard
$3345.00
Group Discounts

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.

To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

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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