Peak Spirit/Regulatory Introduction Biotech in Europe

Regulatory Introduction Biotech in Europe



July 2nd, Wednesday

4.30 - 5.30 PM CEST

This session covers: Biotech

Session held by: Dr. Stephanie Krumholz

Founder and CEO, Therainnova

This webinar will be led by Dr. Stephanie Krumholz, founder and CEO of therainnova AG. An expert with over 20 years of experience in Regulatory Affairs, Dr. Krumholz has guided biopharmaceutical companies through complex regulatory pathways in the EU,  Switzerland, UK, US and several ROW countries. A pharmacist by profession, she holds a Dr. rer. medic from the Department of Obstetrics and Gynaecology in Berlin.

Throughout her career, Dr. Krumholz has successfully led Regulatory Affairs projects from early development to marketing authorization submissions across various therapeutic areas, including small molecules and biologics. She has played a key role in health authority interactions across Europe, Switzerland, and globally, advising on Orphan Designations, Pediatric Plans,  and MAA submissions. With her consultancy, she provides a one-stop-shop for regulatory affairs, PV, nonclinical and operational support.

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