Countdown for FDA Open Seminar 2018

FDA Open seminar

Countdown for FDA Open Seminar 2018

 
Only few weeks for the 5th Edition of our FDA Open Seminar in Barcelona!
 
“FDA Open Seminar: All you need to know!” 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 Mu̱iz of DynaKin will speak about the possibilities of modelling techniques in clinical development.
  
For detailed agenda of the seminar, you can download it here.
 
The new medical device's nomenclature
Asphalion participates in the follow up meeting of nTRACK project

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