- Online training -
Webcode 24092471
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).
Dr. Kurt Eisinger
Eisinger Submission Management, Bisamberg, AUSTRIA
Managing Director After studying biology at the University of Vienna, Kurt Eisinger worked as a project manager in product development at Octapharma. As a project manager at the biotech company igeneon, he came into contact with submission management software for the first time. He subsequently expanded his specialised knowledge as Head of Document Management. Since 2005, he has been working independently as a management consultant in the field of submission management. He creates electronic authorisation dossiers and also supports his clients in the area of regulatory affairs.
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).
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.
18-19/09/2024
18-19/09/2024
Day I: 9:00 am - 5:00 pm
Day II: 9:00 am - 2:00 pm
You may dial in 30 min before the training starts
online
online
Veranstaltung - 1,590 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: CTD Module 3
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Veranstaltung - 1,590 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: CTD Module 3
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Requirements for 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 Kurt Eisinger
Dr Alexandra Günzl and Dr Sabrina Stöhr
Ende of the seminar
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We also offer this seminar as an in-house seminar.
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FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
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