US Regulatory Affairs

Date(s) And Time(s):
Oct 18 2010 7:00AM - Oct 21 2010 4:45PM

Radisson BLU Alcron Hotel
Štepánská 40
11 000 Prague
Czech Republic


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 and who have novice to intermediate experience in Regulatory Affairs, who need an enhanced knowledge of the US regulatory procedures. This course will also be beneficial to and enhance understanding of persons who are in Clinical Research, Data Processing, Biostatistics, Basic Research, Project Management, and Marketing, etc. DIA Europe also welcomes attendance by regulatory agency staff members. Attendees will need to have some knowledge of the ICH and in particular the Common Technical Document (CTD). Participants will gain a better understanding of the regulation of investigational new drugs and biologics, of the basics of submission of applications seeking marketing approval for a product, and post-marketing regulatory requirements.


Role of the regulatory professional
Regulation of drugs and biologics: The basics
Overview of the FDA
Regulatory requirements for drug development and approval
The IND - A general introduction
The IND - In detail
IND Amendment
Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
The NDA in CTD format
Post-Approval regulatory requirements for NDAs
Interactions with FDA
US regulatory requirements for advertising and labelling
Regulatory compliance and FDA Inspections: What to expect after submitting the NDA
Navigating the FDA on the internet

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.
Describe the requirements for New Drug Application (NDA) and Biologics License Application and document preparation.
Demonstrate an understanding of the NDA and the Biologic License Application (BLA) processes and CTD document preparation.
Recognize FDA oversight and processes during the post-approval phase.
Interact appropriately with the FDA during all phases of drug development including the application of good review management practices.
Explain the regulatory requirements for prescription drug labelling and advertising/promotion.
Workshops are utilised in the course to augment the lectures. During such workshops, participants will work in teams on case studies and will present the results to other participants.

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.

Event Code:

Contact Information:
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52