FDA Open Seminar 2018 took place last 7-8 June in Barcelona! ASPHALION together with our partners EXTEDO
organized this training to cover all important aspects that you need to know about FDA Regulatory Affairs
for the success in development and registration of your product.
At the outset, we would like to extend our sincere thanks to all the attendees for its participation and confidence, to the speakers for sharing their expertise and knowledge, and also to Asphalion team for the organization of the event.
The first day, presented jointly with our US agent Bruce Thompson of Reguliance, covered Food and Drug Administration (FDA) basics and provided an overview of all relevant US regulatory activities to obtain a comprehensive vision as a starting point.
Regulatory Affairs during drug development, pre-IND meetings, New Drug Applications, BLA and ANDA were the topics explained in detail by Bruce Thompson, Lidia Cánovas and Michael Schaub during the first part of Day 1.
Due to several important eCTD deadlines in 2018, we also went through the basics of FDA electronic submission requirements. Ralf-Peter Berg, Director Training & Education of EXTEDO, and Vicente Tur, RA Associate Director of ASPHALION presented how to comply with the eCTD specifications.
In addition, we are charmed to count on two excellent external speakers: Marta Zanus of CROS NT
talked about ISS and ISE requirements
, unique to FDA and a challenge for many companies. Paula Muñiz of DynaKin
presented the possibilities of modelling techniques in clinical development
On the second day, attendees were be able to choose between two parallel sessions.
Track 1, presented together with our technology partner EXTEDO is offering an in-depth FDA eCTD software training (using eCTDmanager). Ralf-Peter Berg from Extedo, and Vicente Tur and Lara Alarcón from Asphalion are runing a practical workshop on eCTD, covering NDA submission, study tagging files, exporting and validating. It is a unique occasion to apply your new knowledge and even build your first FDA eCTD submission
During Track 2, Our experts Lidia Cánovas and Chris Mann explained the specific requirements and timelines of Orphan Drug Designation and Pediatric Product Development in FDA.
How to go faster? Marta Rayo Lunar and Lidia Cánovas showed alternative pathways to speed up your registration: Breakthrough therapy, Fast track, Accelerated approval, Priority review.
Besides Marta and Michael Schaub illustrate a Practical case on the preparation of IND departing from EU IMPD.
All in all, we hope attendees enjoyed the event as much as we did, found it useful and learned how to apply acquired knowledge to your current FDA projects.
We look forward to seeing you at next Open Seminar edition!
Asphalion Open Seminar Team
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