Perspectiva general

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 will focus on drug and biologic products; the regulatory process for devices or multisourced (generic) products will not be addressed.

Lo que aprenderá

Regulation of drugs and biologics: The basics
Overview of the FDA
Regulatory requirements for drug development and approval
Interactions with FDA
Submitting the NDA in CTD format – What’s unique to FDA
Post-approval regulatory requirements for NDAs
US regulatory requirements for advertising and labelling
Regulatory compliance and FDA Inspections: What to expect after submitting the NDA

¿Quiénes deben asistir?

This course is specifically 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 beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc.
DIA Europe, Middle East & Africa also welcomes attendance by regulatory agency staff members.

Objetivos de aprendizaje

At the conclusion of this course, participants will 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 key 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 (BLA) and document preparation
Recognise FDA oversight and processes during the post-approval phase
Interact appropriately with the FDA during all phases of drug development

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

The world of health care product development is rapidly evolving. To keep you at the forefront, DIA offers a broad selection of expert-led training courses in the key disciplines of Regulatory Affairs, Clinical Research and Pharmacovigilance, as well as courses created to develop other key competencies in the area of e.g. Biosimilars or HTA.

DIA can deliver this course at your organisation on dates that suit you. Our offerings can be customised to meet your exact needs. Learn how DIA can bring our outstanding training programmes directly to you and your team.
For more information please contact EMEA@diaglobal.org.

Digital Learning Catalog

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A Comprehensive Review of Regulatory Procedures for New Drug Applications in the US