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 speci?cally designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, and 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 bene?cial 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.
What You Will Learn
- 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 Amendments and maintenance
- Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
- Submitting the NDA in CTD format – What’s unique to FDA
- 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
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 multisourced (generic) products will not be addressed.
Hotel & Travel
DIA has blocked a limited number of rooms at the following hotel:
Mercure Paris la Villette
216 Avenue Jean Jaurès
Tel:+33 (0) 1 44 84 18 18
Fax:+33 (0) 1 44 84 18 20
at the rates of:
EUR 180.00 per room inclusive of breakfast and VAT.
To make your reservation, please use the hotel booking from available on this link.
Important: The room rate is available until 22 September or until the group block is sold-out, whichever comes first.
Cancellation policy for bedrooms:
No change or cancellation can be made after booking.
The client acknowledges that first night of the stay will be charged when the booking is made.
Kuechengasse 16, Postfach
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52