NVFG Advanced Course Regulatory Affairs

NVFG

Van der Valk hotel Breukelen

Unlocking Regulatory Success: Marketing Authorisation Application Dossier Advanced CourseAre 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 courseThe 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:<ul><li>The regulatory framework governing Marketing Authorisation dossiers</li><li>Content and structure of the Marketing Authorisation Dossier, (e)CTD</li><li>Common challenges in dossier preparation and strategies to mitigate them</li><li>Practical case study to reinforce learning and apply concepts</li></ul> 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<ul><li>Date: Tuesday 6 May 2025, 9:00h to 17:00h</li><li>Location: hotel Breukelen, Breukelen</li><li>Lunch included</li><li>Format: 1 day meeting, presentations and interactive sessions</li><li>Depending on the preference of the majority of participants, the presentations will be in Dutch or English</li><li>Course materials, in English, will be provided, where possible</li></ul> Registration<ul><li>Register via: <a href="https://www.nvfg.nl/activiteiten/" title="https://www.nvfg.nl/activiteiten/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">https://www.nvfg.nl/activiteiten/</a></li><li>Maximum of 30 participants: register now!</li><li>Fee: € 200,- (excl. BTW) for NVFG members, € 350,- (excl. BTW) for non-members</li><li>Note: the fee to become a member of NVFG is €135,- in the first year and €185,- annually thereafter</li></ul>We look forward to seeing you there!

Onze {communityGuidelinesLink} beschrijven wat voor content verboden is op Eventbrite. Als je denkt dat een evenement deze schendt, meld dit dan aan ons, zodat wij het kunnen onderzoeken.

Om andere categorieën van verboden of illegale content te rapporteren, verzend je {link}

NVFG Advanced Course Regulatory Affairs

Meer evenementen van NVFG

Ontdek meer evenementen van NVFG, van Wetenschap en tech tot andere ervaringen die je misschien leuk vindt.

NVFG Advanced Course Regulatory Affairs

Meer evenementen van NVFG

Ontdek meer evenementen van NVFG, van Wetenschap en tech tot andere ervaringen die je misschien leuk vindt.

Misschien vind je dit ook leuk...

Blader door meer evenementen met verschillende datums, prijzen en formats om je volgende geweldige ervaring te vinden.