QDossier Presenting on FDA Drug Approval Process

During this course, you will gain a deep understanding of the eCTD submission process for FDA drug approval. This program covers procedures for submission of INDs, NDAs, ANDAs, and 505(b)(2). It provides a useful insight into the organization and structure of the FDA and its review processes and highlights recent changes.

The course is well structured and organized in 8 modules which helps the audience to understand the entire drug approval process in a continuous flow.

Module 1: History and review of the organization of the US Food and Drug Administration (FDA) and future vision

Module 2: The drug development regulations in the US and implications for the industry

Module 3: Analysing the Investigational New Drug Application (IND) and defining the regulatory requirements

Module 4: Evaluation of review options

Module 5: Identifying the various categories of NDAs

Module 6: Generic Submissions

Module 7: How does the FDA review and maintain an NDA

Module 8: Interacting with the FDA and obtaining information from the FDA

Speakers:

Hans Van Bruggen

Marloes van der Geer