Asphalion is excited to announce the 4th edition of our FDA OPEN SEMINAR!
“FDA OPEN SEMINAR 2017: Opportunities ahead” will provide a structured introduction to all important aspects of FDA regulatory affairs.
The first day, presented jointly with our US agent Bruce Thompson of REGULIANCE, will provide a thorough understanding of US regulatory activities.
On the second day, attendees will be able to choose between two different sessions. On the one hand, together with our technology partner EXTEDO we will offer an in-depth FDA eCTD software training (using eCTDmanager).
The main innovation of this is year is that we will offer a parallel track on the second day, which will provide a detailed insight into several key topics: Biosimilar development and registration, combination product requirements, practical analysis of the NDA 505(b)(2) pathway, as well as the US generic pathway ANDA.
We are pleased to invite you to join us in Barcelona to refresh or to start your FDA knowledge and expertise! Our experts will share their practical experience of many years of dealing with FDA submissions. All aspects will be covered, from setting the initial strategy, preparing and submitting regulatory dossiers, up to successful marketing authorization in the USA.
You can also contact us for more information at openseminar@asphalion.com
We look forward seeing you there!
