Focus on small molecules and biologics
Webcode 26092470
Dr. Alexandra Günzl
Karyon Biopharma Consulting e.U., Vienna, AUSTRIA
Non-Clinical Consultant and Founder In early 2023 Alexandra Günzl founded Karyon Biopharma Consulting e.U. and supports clients as a non-clinical consultant in a wide range of issues related to non-clinical drug development. In her former position as Non-Clinical Consultant at MC Toxicology Consulting GmbH where she worked for more than 10 years, she contributed to the successful development of numerous drug candidates with a focus on biologics and ATMPs. She studied biotechnology with a focus on biomedicine and was trained in experimental cancer research during her PhD. Alexandra Günzl deepened her regulatory expertise through postgraduate training on "Regulatory Affairs of Biopharmaceuticals including ATMPs" (EUCRAF).
Nina Kappler
Kappler Pharma Consult GmbH, Leipheim, GERMANY
Pharmacist, MBA, Managing Director
Team Leader Pharmakovigilanz & Team Leader Innovations
After studying pharmacy, she worked as a regulatory affairs manager and took over the family business in 2019. She has more than 8 years experience in (WEU) submissions and regulatory strategy.
More information please click here.
Dr. Sabrina Stöhr
Merck Healthcare KGaA, Darmstadt, GERMANY
Associate Director Medical Writing After her studies in human and molecular biology and research in cell biology, Sabrina Stöhr focussed on clinical research. For more than 10 years, she has been working as a medical writer on the preparation of clinical authorisation documents in various therapeutic areas. She deepened her expertise with a Master's degree in Drug Regulatory Affairs (DGRA).
Dr. Hans Rensland
RACON Regulatory Affairs Consulting GmbH, Berlin
Independent Consultant
Dr Hans Rensland has 30 years of experience in clinical research and regulatory affairs. With his many years of professional experience in the pharmaceutical industry, he founded his own consulting company in 2012.
More information please click here.
21 - 22/09/2026
21 - 22/09/2026
Day I: 9:00 am - 5:00 pm CET
Day II: 9:00 am - 2:00 pm CET
You may dial in 30 minutes before the training starts
online
online
Event - 1,690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 1,690€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Non-clinical/clinical content in the dossier: Are you a beginner in the field and would like to feel confident working competently on modules 2, 4 and 5 in the future? Are you already an experienced specialist and would like to refresh, professionalise or "structure" your knowledge? Then you've come to the right place!
This online seminar will provide you with an overview of the relevant non-clinical and clinical data for preparing the authorisation application dossier.
You will discuss these questions with the experts, among others:
Thanks to the numerous topic-specific and practical tips from our speakers and the application of what you have learnt during the workshop
Welcome, introduction, expectations
Dr Alexandra Günzl
Dr Alexandra Günzl
Lunch break
Dr Sabrina Stöhr
Nina Kappler
Recap and outstanding questions
End of seminar day I
Dr. Hans Rensland
Dr Alexandra Günzl and Dr Sabrina Stöhr
Ende of the seminar
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