Training & Lectures
We offer tailored training courses and seminars on the following topics:
- Non-clinical development for all product types including small molecules, biologics and ATMPs
- Regulatory writing
- CTD preparation
Our most recent trainings & presentations include:
Current
- All About ATMPs FORUM Institut für Management.
Online, 28.-29.9.2021
- Toxicology Summer School FORUM Institut für Management.
Online, 24.-26.8.2021
- PharmaFORUM Webcast Biologics 2021: Establishing a starting dose for a first-in-human clinical trial: a challenge for gene/ cell therapies
6.7.2021
- Präklinik kompakt FORUM Institut für Management.
Online, 9.-11.6.2021
- All About ATMPs FORUM Institut für Management.
Berlin, 24.-25.3.2021
Previous Examples (2006 – 2020)
Previous Seminars at Forum Institut für Management:
- Biotech-Arzneimittel
- All about ATMPs
- Krebsvakzine kompakt
- Cancer Vaccines
- Particulars of authorisation of biopharmaceuticals
- Molekularbiologie für Nicht-Molekularbiologen
- Step by Step durch die Präklinik
- Von der Präklinik zur klinischen Phase I
- Summer and Winter School of Toxicology
- Basics in F&E: Non-Clinical Requirements for First-in-Man Studies
- Das Common Technical Document (CTD) - Modul für Modul
- CTD Dossiers selbst erstellen
- CTD und eCTD: Dossiererstellung und Einreichung
- Marketing Authorisation Application
- Dos & Don’ts in Regulatory Writing
Other Seminars and Talks
- Fresenius Kabi 6th Global Preclinical Meeting "Introduction to Translational Science" (2016)
- EUCRAF "Non-Clinical Development of Biopharmaceuticals; Tegenero and BIAL Cases; Deviating from Standard Requirements, the Non-Clinical CTD" (2016)
- 5th BIOART Meeting "Advanced Therapy Medicinal Products: Non-Clinical Requirements to Allow for First-in-Human Use" (2015)
- EUCRAF "Particulars of authorization of biopharmaceuticals" (2011)
- EAPB Special Interest Groups: Regenerative Medicine "Challenges in the Non-Clinical Development of Cell-Based Therapies" (2010)
- Translationszentrum für Regenerative Medizin (TRM) "Non-Clinical Development of Advanced Therapy Medicinal Products (ATMPs)" (2010)
- Colloquium Pharmaceuticum GmbH "Summerschool: Drug Regulatory Affairs" (2007, 2008, 2009)
- TOPRA Prague "Regulatory Strategy for a New Active Substance: Preclinical Development" (2007)
- Fraunhofer Institute for Toxicology and Experimental Medicine "Strain Differences in Hepatocarcinogenesis between C3H/He and C57Bl/6J Inbred Mice" (2006)
Teaching Position (Regulatory Affairs)
at the University of Applied Sciences in Wiener Neustadt, Austria (Master’s degree program „Biotechnology Processes“)
In-House Tailored Training Courses
for selected companies and clients