Revive the FDA Open Seminar 2017 with this summary!

Revive the FDA Open Seminar 2017 with this summary!

FDA Open Seminar 2017 took place last 1-2 June in Barcelona! ASPHALION together with our partners EXTEDO and REGULIANCE organized this Road Trip through FDA Regulatory Affairs to point out opportunities ahead that European pharmaceutical companies can have in US.
First of all, 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.
 
This 4th edition of the Seminar provided a structured introduction to all important aspects of FDA regulatory affairs, but also covered current hot topics and recent changes in the USA.
 
The first day kicked off with an overview of the FDA. Bruce Thomson, Principal of Reguliance, jointly with Michael Schaub, Asphalion?s Munich Director Office, presented political changes in the USA affecting the Agency as well as establishment registration and combination product requirements.
 
 
Next, we had the special collaboration of Palobiofarma. Julio Castro-Palomino explained their real case at FDA. We would like to give our special thanks to Julio for sharing with us their success story. 
 
 
Following, there were several lectures about Regulatory Affairs during Development. This third session included US Agent requirements and Pre-IND meetings by Bruce Thompson, and also an illustration of Pediatric Product Development given by Asphalion’s expert Christopher Mann.
 
 
 
FDA application types and Dossier Requirements, including DMF, IND, NDS,  505 (b)(2) and BLA, were covered by Lidia Cánovas, General Manager Regulatory Affairs at Asphalion, Michael Schaub and Bruce Thompson.
 

We had lunch break at the impressive terrace of the hotel venue, enjoying
the sun and Barcelona’s view. At this point we would like to show our gratitude
to Hotel Condes de Barcelona that professionally and warmly host the event.

The afternoon session was dedicated to eSubmission and Electronic Gateways
ran by Remco Munnik, Asphalion’s Regulatory Information Director, jointly with
Ralf-Peter Berg, Director Training&Education at Extedo.

 
 
To finalize the first day, Lidia Cánovas made a comparison between FDA and
EMA dossier registration.
 

On the second day, two parallel tracks were offered.

On the one hand, a complete insight on FDA key topics was given by Lidia
Cánovas, including ODD, ANDA pathway and post-approval activities.

Medical Devices were covered by our expert Sheila Galan.

 
Special thanks to Octavi Colomina, Technical Director of TDV for his collaboration
on the Seminar providing FDA inspection keys.

 

On the other hand, Ralf-Peter Berg form EXTEDO provided a quick orientation
in the eCTDmanager and practical experience with workshops on NDA submissions,
SPL and validation.

All in all, we hope attendees enjoyed the event, found it useful and
learned how to apply acquired knowledge to FDA projects and issues.

We look forward to seeing you at next FDA Open Seminar edition!

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