Regulations, data and study programs, transition to Phase I, small molecules and biologics
Webcode 26122470
Dr. Volker Blust
PHOX Consulting e.U., Vienna, AUSTRIA
Volker Blust is the owner of PHOX Consulting e.U., an independent consultancy based in Vienna specialising in the non-clinical and biological evaluation of medical devices and medicinal products. He has extensive experience with a wide range of product types, including substance-based medical devices and implants. As a consultant, he works with companies to develop testing strategies for medical devices, acts as a study monitor for external trials, and prepares regulatory documents such as biological evaluation plans and reports (BEP/BER) as well as toxicological risk assessments. Volker Blust studied food chemistry at the Karlsruhe Institute of Technology and completed his doctorate in toxicology at the University of Vienna. Following advanced training in the field of toxicology, he has been registered as a European Registered Toxicologist (ERT) in the European and Austrian toxicologist registers since 2018.
Dr. Meike Harms
Merck KGaA, Darmstadt, GERMANY
Meike Harms holds a doctorate in pharmacy and has been working in the Healthcare division at Merck KGaA in Darmstadt since 2011. Throughout this time, she has mainly been involved in the preclinical formulation development of new drugs. In the field of formulations, she has gained experience in various areas such as special application routes (e.g. intra-articular or transdermal), bioavailability improvement via amorphous formulations, nanosuspensions and lipid-based formulations as well as drug targeting to reduce toxic effects.
Dr. Lutz Wiesner
Expert for Preclinical Research, Bonn, GERMANY
Dr. Matthias Germer
Biotest AG, Dreieich GERMANY
Vice President Preclinical Research Matthias Germer has been Head of Preclinical Research at Biotest AG since 1999 and is responsible for the non-clinical parts of study submissions and product approvals for biotherapeutic and biological drugs in the EU, the USA and other countries. Since then he has been an expert in analytics under GMP and GCLP, pharmacology, toxicology and pharmacokinetics. As head of the testing facility, he is responsible for the organization and functioning according to GLP principles. He shares his know-how in numerous congresses, lectures and seminars .
Dr. Bernd-Bodo Haas
Toxicology Expert, Bonn, GERMANY
Specialist in Genetic and Reproductive Toxicology He works at the Genetic and Reproductive Toxicology, Bundesinstitut für Arzneimittel und Medizinprodukte and does research in Diabetology, Pharmacy and Toxicology.
01 - 03/12/2026
01 - 03/12/2026
Day I+II: 9:00 am - 5:30 pm CET - Online training
Day III: 9:00 am - 1:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts
online
online
Event - 1,990€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
01 - 02 December 2026: € 1.990,00 (+ german VAT)
01 - 03 December 2026: € 2.290,00 (+ german VAT)
OPTIONS
Booking day 1-3
+300,00 €
Booking day 1-2
+0,00 €
Event - 1,990€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
01 - 02 December 2026: € 1.990,00 (+ german VAT)
01 - 03 December 2026: € 2.290,00 (+ german VAT)
OPTIONS
Booking day 1-3
+300,00 €
Booking day 1-2
+0,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and biologics. Learn about the fundamentals and regulatory requirements and take the opportunity to discuss the challenges in your practice with our experts and industry colleagues.
After Day I+II, you will be familiar with the regulatory framework for preclinical - focus on small molecules. You have intensively dealt with the sub-areas of (safety) pharmacology, pharmacokinetics and toxicology and you know which challenges exist in formulation development.
You have deepened the required preclinical study program to generate data for clinical phase I as well as the requirements for preclinical documentation. Last but not least, you will be able to assess when Scientific Advice on non-clinical issues is appropriate.
After Day III (optionally bookable), you will be familiar with the preclinical specifics regarding biochemicals and monoclonals too.
As part of this compact course, our experts will teach you how to move quickly and efficiently from drug screening to first-in-human studies.
Here you will receive first-hand regulatory and practical expertise.
On day I+II our experts will share their know-how in the field of small molecules with you, on day III the focus will be on biochemicals and monoclonals.
Opening and introduction round
Dr Volker Blust
Dr Meike Harms
Dr Volker Blust
Dr Volker Blust
Dr Volker Blust
End of day I
Dr Volker Blust
Dr Lutz Wiesner
Dr Volker Blust, Dr Lutz Wiesner
Dr Volker Blust, Dr Lutz Wiesner
Dr Volker Blust
Dr Lutz Wiesner
Dr Volker Blust
Recap and outstanding questions (day I+II)
End of day II
Dr Bernd-Bodo Haas
Dr Matthias Germer
Dr Bernd-Bodo Haas
Dr Bernd-Bodo Haas
Recap and outstanding questions (day III)
End of online training
Booking day 1+2
Booking day 1+2+3
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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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Teilnehmerstimmen aus Januar 2017
Guter Überblick von regulatorischen und wissenschaftlichen Blickpunkten, viele Beispiele
Lockere Atmosphäre, schöne Veranstaltung
Sehr gut vorbereitete und strukturierte Inhalte
Sehr gute Übersicht über die Thematik, inhaltlich sehr gut ausgearbeitet; Zeit für Fragen, angenehmes Tempo
