Veranstaltungen

FDA Regulatory Affairs during Drug Development – Your Road to Success

BioM in cooperation with Reguliance and Asphalion invite you to a practical workshop that offers an in-depth look into US FDA Regulatory Affairs, focusing on real-life situations of European drug development companies.

BioM in cooperation with Reguliance and Asphalion

Time and Place:
Tuesday, 23 January 2018, from 8:30 – 16:30
BioM Biotech Cluster Development GmbH
Am Klopferspitz 19a (IZB-West II)
Germany-82152 Martinsried

It is vital in modern drug development to understand the regulatory requirements and opportunities of the main markets around the world. The US in particular, with its Food and Drug Administration (FDA) leading the way in many aspects of how drugs and biologicals are regulated, needs to be considered in early phases of drug development.

Reguliance and Asphalion invite you to a practical workshop that offers an in-depth look into US FDA Regulatory Affairs, focusing on real-life situations of European drug development companies.

Latest political changes in the US and their practical implications for companies will be discussed as part of the general overview of how FDA operates and what rules apply in the US for human medicines.

All relevant regulatory activities will be explained throughout the sessions and illustrated by practical cases and experiences of the speakers, including FDA meetings, IND strategy for clinical trials, Orphan Drug Designation and Pediatric Product Development.

A central theme of this event will be the analysis of regulatory options for adding maximum value to your product development. The best position before partnering/licensing is to consolidate a thorough regulatory strategy in combination with an understanding of FDA incentive and alternative pathways, such as Breakthrough Therapy, Fast Track, Accelerated Approval, and Priority Review.

Your speakers will be Bruce Thompson of Reguliance, with 25 years of FDA experience, together with Asphalion's FDA expert Team.

Speakers:
Bruce Thompson – Principal and Consultant at REGULIANCE
Lidia Cánovas – General Manager Regulatory Affairs at ASPHALION
Christopher Mann – Scientific and Regulatory Affairs Manager at ASPHALION
Michael Schaub – Director Munich Office at ASPHALION
Meet the speakers:
Reguliance and Asphalion experts will be available for personal meetings on the days before and after the event. You can arrange your meeting at fda@remove-this.asphalion.com.

A detailed agenda you can find here:
Agenda_FDA Regulatory Affairs during Drug Development – Your Road to Success

Fees:
General Public / Industry: 140 €
Student / Academic: 85 €

For your registration please fill in the form below.