We are excited to announce the 4th edition of our FDA OPEN SEMINAR!
“FDA OPEN SEMINAR 2017: Opportunities ahead”, which will take place in Barcelona, Spain on 01-02 June 2017, will provide a structured introduction to all important aspects of FDA regulatory affairs, but will also cover current Hot Topics as well as recent changes in the USA and their consequences.
The first day, presented jointly with ASPHALION's US agent Bruce Thompson of REGULIANCE, will provide a thorough understanding of US regulatory activities during product development phases as well as a detailed and comprehensive vision of the distinct application types and dossier requirements for product registration. In addition, we will cover the basics of electronic submission requirements and present a case study of converting an EU dossier into a US dossier.
On the second day, attendees will be able to choose between two different sessions. On the one hand, we will offer an in-depth FDA eCTD software training (using EXTEDO eCTDmanager™), held by Sophia Vraka of EXTEDO. This practical workshop on eCTD will be a unique occasion to apply your new knowledge and build (your first) FDA eCTD submission.
New this year, 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.
Agenda 1st June:
- USA and FDA Hot Topics!
- US Success Story of one of ASPHALION’s clients
- FDA Regulatory Affairs during development phases
- Overview of all FDA application types and dossier requirements
- Introduction to eSubmission
- Comparison and conversion: FDA vs. EMA
- More time for Q&As
Agenda 2nd June – Track 1: practical eCTD Training
- Practical FDA eCTD workshop using EXTEDO’s eCTDmanager
- Hands-on FDA eCTD compilation
- Analysis of differences between US and EU eCTDs
- Introduction to FDA Module 1
- Study reports and study tagging files
Agenda 2nd June – Track 2: In-depth FDA Regulatory Affairs
- Biosimilar development and registration
- Combination product requirements
- NDA 505(b)(2) pathway, incl. bridging examples
- US ANDA pathway for generic products
Registration fee: 400€
(250€ fee for single day participation)
*The fee includes: tuition, teaching materials, lunch break on day 1, organizational assistance, attendance certificate. Fee is subject to 21% VAT