Us Regulatory Affairs: A Comprehensive Review of Regulatory Procedures

Us Regulatory Affairs: A Comprehensive Review of Regulatory Procedures



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Pullman Brussels Centre Midi

Place Victor Horta 1, 1060 Saint-Gilles, Brussels, Belgium Mappa

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

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 seeing marketing approval for a product (NDA & BLA) 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

On Monday November 14, 2016 at 8:00 am (ends Wednesday November 16, 2016 at 5:15 pm)

Category: Conferences - Science, Health & Medicine - Pharmace

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