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.
Berlin, 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
- Präklinik kompakt FORUM Institut für Management.
Online-Weiterbildung, 10. - 12.11.2020
- All About ATMPs FORUM Institut für Management.
Berlin, 6.-7.5.2020
- Präklinik Kompakt FORUM Institut für Management
Bonn, 12.-14.2.2020
- Toxicology Summer School FORUM Institut für Management.
Bonn, 21.-23.08.2019
- All About ATMPs FORUM Institut für Management.
Berlin, 15.-16.5.2019
- Facing Challenges Transitioning from Basic Research to Early Non-Clinical Development. ASTOX Symposium 2019
Vienna, 26.04.2019
- From Pre-Clinics to Phase I. Meet World Courier & Industry Experts @ ViennaBioCenter.
Vienna, 5.4.2019
- Biotech Arzneimittel FORUM Institut für Management.
Mainz, 19.-21.3.2019
- Gentherapeutische Arzneimittel FORUM Institut für Management.
Frankfurt, 27.2.2019
- Präklinik Kompakt FORUM Institut für Management.
Heidelberg, 29.-30.1.2019
- Präklinik Kompakt FORUM Institut für Management
Bonn, 29.-30.1.2019
- Biotech-Arzneimittel FORUM Institut für Management.
Frankfurt, 20.-22.11.2018
- Toxicity and Safety Testing with CRISPR/Cas-Based Therapeutics. Boston Symposium 2018, Citoxlab Safety and Health Research,
Boston, 13.9.2018
- Regulatory Affairs in Drug Development, INiTS - Entrepreneurship training of Max F. Perutz Laboratories,
Wien, 5.-7.09.2018
- Toxicology Compact in Toxicology Summer School
Frankfurt, 08.-09.08.2018
- All About ATMPs FORUM Institut für Management.
Frankfurt, 15.-16.5.2018
- Leading the Edge: Toxicity and Safety Testing with CRISPR/CAS-based Therapeutics SOT Society of Toxicology.
San Antonio, Texas, 11.-15.3.2018
- Biotech Arzneimittel FORUM Institut für Management.
Frankfurt/Offenbach, 27.2.–1.3.2018
- Präklinik Kompakt FORUM Institut für Management.
Bonn, 30.-31.1.2018
- Toxicology Winterschool FORUM Institut für Management.
Mannheim, 23.-25.1.2018
- Dos and Don'ts in Regulatory Writing
FORUM Institut für Management
27.09.2017
- Regulatory Toxicology Methods Workshop
FORUM Institut für Management
16.-17.8.2017
- Biotech Arzneimittel
FORUM Institut für Management
August 2017
- All about ATMPs
FORUM Institut für Management.
Frankfurt, 16.-17.05.2017
- Biotech-Arzneimittel
FORUM Institut für Management.
Frankfurt / Offenbach, 15.-17.02.2017
- Assistenz in der Pharmaindustrie
FORUM Institut für Management
Frankfurt, 31.01.2017
- Präklinik Kompakt
FORUM Institut für Management
Bonn, 26.-27.1.2017
- Toxicology Winter School
FORUM Institut für Management
Köln, 16.-20.1.2017
- CTD versus technische Dokumentation
FORUM Institut für Management.
Frankfurt, 28.09.2016
- Teaching position (Regulatory Affairs)
at the University of Applied Sciences at Wiener Neustadt, Austria (Masters degree programm „Biotechnology Processes“)
- Dos & Don’ts in Regulatory Writing
FORUM Institut für Management
Frankfurt, 27.09.2016
- Summer School Toxicology
FORUM Institut für Management
August 2016
- Von der Präklinik zur klinischen Phase I
FORUM Institut für Management.
Stuttgart, 20.-21.06.2016
- All about ATMPs
FORUM Institut für Management.
Mainz, 11.-12.05.2016
- Biotech-Arzneimittel
FORUM Institut für Management.
Heidelberg, 24.-26.02.2016
Previous Examples (2006 – 2015)
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