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Regulatory Affairs: The IND, NDA, and Postmarketing

Aug 18 2014 8:00AM - Aug 21 2014 4:00PM | Sheraton Boston Hotel 39 Dalton Street, Boston, MA 02119 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. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Course Level: Beginner


"This is the first DIA course I have taken and by far, the best I've ever taken. The instructors have a wealth of knowledge and experience with Regulatory Affairs and the FDA. A great class overall."

"This Regulatory class was the best course I've ever taken. A huge thanks to all for making it a valuable and wonderful experience!"

"This was a great beginner course in regulatory affairs. I learned a lot and was able to meet people from different companies."

What You Will Learn 

  • Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
    • Preparation
    • Content
    • Strategy
  • Meetings and other interactions with FDA
  • Prescription Drug Labeling
  • Postmarketing Requirements

Who Should Attend 

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

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 (CTD) 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
  • Outline the regulatory requirements for prescription drug labeling

Special Offers 

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

Hotel & Travel 

Hotel and Course Location / Information

Sheraton Boston Hotel
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until August 04, 2014, or until room block is filled). Attendees must make their own hotel reservations.

Standard Room Rate $199
Hotel Address: 39 Dalton Street • Boston, MA 02199 • United States
Click here for Reservations  

The most convenient airport is Logan Airport and attendees should make both airline and hotel reservations as early as possible.

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 Logistics
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).

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 2.9 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 29.00 2.900

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

Printable Registration Form

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

Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.

Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.

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.

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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