Unlocking Regulatory Success: Marketing Authorisation Application Dossier Advanced Course
Are you ready to elevate your expertise in Regulatory Affairs?
Our advanced course, "Unlocking Regulatory Success: Marketing Authorization Application Dossier", is designed for Regulatory Affairs professionals who seek to deepen their understanding of the Marketing Authorization Application (MAA) dossier, specifically focusing on the structure and content outlined in the Common Technical Document (CTD). Participants will gain comprehensive knowledge of the essential components required for successful regulatory submissions.
This course is organised by RegNed, a division of NVFG.
Content of the course
The aim of the course is to provide the participants with a better and deeper understanding of the content and components of the Marketing Authorization Application Dossier for human medicines, with a focus on EU. During the course, the following topics will be addressed:
- The regulatory framework governing Marketing Authorisation dossiers
- Content and structure of the Marketing Authorisation Dossier, (e)CTD
- Common challenges in dossier preparation and strategies to mitigate them
- Practical case study to reinforce learning and apply concepts
Who Should Attend?
This course is intended for Regulatory Affairs professionals, and anyone involved in the preparation and submission of marketing authorization applications.
Course Practicalities
- Date: Tuesday 6 May 2025, 9:00h to 17:00h
- Location: hotel Breukelen, Breukelen
- Lunch included
- Format: 1 day meeting, presentations and interactive sessions
- Depending on the preference of the majority of participants, the presentations will be in Dutch or English
- Course materials, in English, will be provided, where possible
Registration
- Register via: https://www.nvfg.nl/activiteiten/
- Maximum of 30 participants: register now!
- Fee: € 200,- (excl. BTW) for NVFG members, € 350,- (excl. BTW) for non-members
- Note: the fee to become a member of NVFG is €135,- in the first year and €185,- annually thereafter
We look forward to seeing you there!
