US Regulatory Affairs: A Comprehensive Review of Regulatory Procedures for INDs and NDAs in the US

Venue: Marriott Rive Gauche Hotel

Location: Paris, France

Event Date/Time: Nov 14, 2011 End Date/Time: Nov 16, 2011
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As drug development becomes a global process, have you had questions about US Regulatory requirements? Do you wonder why your US colleagues ask for certain documents or information?

This course is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, drug metabolism), clinical research, quality assurance or academia, with novice to intermediate experience in Regulatory Affairs, who need knowledge of the US regulatory processes. This course will also enhance understanding and be beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc. DIA Europe also welcomes attendance by regulatory agency staff members. Participants need to have some knowledge of the ICH and in particular the Common Technical Document (CTD).
Participants will gain a better understanding of the US regulation of investigational new drugs (INDs) and biologics, of the basics of submission of applications seeking marketing approval for a product and
post-marketing regulatory requirements in the US.

Learning Objectives:
At the conclusion of this course, participants should be able to:
• Define the key principles and processes used by the US Food and Drug Administration (FDA) in
regulatory submission and approval.
• Define official regulatory policies and other issues pertinent to a successful US regulatory strategy
• Describe major differences between US and EU regulatory requirements
• Describe the requirements for marketing applications for drugs and biologics , New Drug Application
(NDA) and Biologics License Application and document preparation.
• Recognise FDA oversight and processes during the post-approval phase.
• Interact appropriately with the FDA during all phases of drug development
• Understand the regulatory requirements for prescription drug labelling and advertising/promotion and
differences with EU requirements.
This course will focus on drug and biologic products; the regulatory process for devices or multi-sourced (generic) products will not be addressed.

Target Audience:

This course is designed for newly hired regulatory affairs professionals with backgrounds of less than six months’ experience or who are making a career change into regulatory affairs. The course will benefit those pharmaceutical industry professionals who are new to the Investigational New Drug Application (IND) process, New Drug Application (NDA) process and the Common Technical Document (CTD).

This course will also benefit professionals in clinical research, data processing, biostatistics, basic research, project management, and marketing, who would like to gain a better understanding of the regulation of investigational new drugs and biologics.

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