This seminar,organized by our partner ASPHALION, 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 US and their consequences.
The first day, presented jointly with our US agent Bruce Thompson of Reguliance, will cover Food and Drug Administration (FDA) basics and all relevant US regulatory activities.
Attendees will obtain a comprehensive vision of when and how to interact with FDA during drug development and registration phases. All application types and the respective dossier requirements will be explained and illustrated by real-life examples. As suggested by attendees of our previous Open Seminar, we have included this year a practical case session on meetings with FDA .In addition, we are excited to announce two excellent external speakers: Marta Zanus of CROS NT will discuss ISS and ISE requirements, unique to FDA and a challenge for many companies. Paula Muñiz of DynaKin will speak about the possibilities of modelling techniques in clinical development. Due to several important eCTD deadlines in 2018, we will also cover the basics of FDA electronic submission requirements.
On the second day, attendees will be able to choose between two parallel sessions.
Track 1, presented together with EXTEDO, will offer an in-depth FDA eCTD software training (using eCTDmanager™). This practical workshop on eCTD will be a unique occasion to apply your new knowledge and build (your first) FDA eCTD submission.
Track 2 will be a practical workshop on FDA drug development. We will cover the details of important regulatory requirements, such as for Orphan Drug Designation (ODD) and pediatric development, but we will also speak about regulatory options for adding maximum value to your development, such as via expedited pathways and FDA incentives. To further increase the interaction with the attendees, we have included two additional practical cases: converting an IMPD to IND and US-EU parallel drug development.
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
For detailed agenda and registration
We are pleased to invite you to join us in Barcelona to refresh or to start your FDA knowledge and expertise!