- Online training -
Webcode 24122470
Dr. Volker Blust
PHOX Consulting e.U., Wien
Volker Blust is the founder of PHOX Consulting. He started his career in 2013 by joining MC Toxicology Consulting, a company specialized in nonclinical development and toxicology. At MC Toxicology Consulting, Volker has worked on multiple drug candidates including small molecules, herbals, biologics, and vaccines. In addition, he has contributed to the successful development of substance based medical devices and implants. In 2021 Volker founded PHOX Consulting. During his work as a senior consultant for nonclinical development and toxicology of drugs and medical devices Volker has authored respective sections in various regulatory documents (CTDs, INDs, Briefing Documents, and IBs), biocompatibility reports, toxicological risk assessments and PDE calculations. Volker studied food chemistry at the Karlsruhe Institute of Technology in Germany and completed his doctoral studies in the field of toxicology at the University of Vienna, Austria. In 2018 he received his certificate as a European Registered Toxicologist.
Dr. Meike Harms
Merck KGaA, Darmstadt
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
Preclinical expert, Bonn
Dr. Matthias Germer
Biotest AG, Dreieich
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
- requested - Expert for Toxicology, Bonn
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.
09-11/12/2024
09-11/12/2024
Day I: 09:00 am - 05:30 pm - Online seminar
Day II: 09:00 am - 05:15 pm - Online seminar
Day III: 09:00 am - 12:45 pm - Online seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,890 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
09 - 10 December 2024: € 1.890,00 (+ german VAT)
09 - 11 December 2024: € 2.190,00 (+ german VAT)
OPTIONS
Booking day 1-3
+400,00 €
Booking day 1-2
+0,00 €
SPECIAL OFFER
e-Learning: GMP für das non-GMP Umfeld
, online
Simply register for the seminar and receive a €100 discount on the e-learning programme (€390 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
390,00 €
Veranstaltung - 1,890 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
09 - 10 December 2024: € 1.890,00 (+ german VAT)
09 - 11 December 2024: € 2.190,00 (+ german VAT)
OPTIONS
Booking day 1-3
+400,00 €
Booking day 1-2
+0,00 €
SPECIAL OFFER
e-Learning: GMP für das non-GMP Umfeld
, online
Simply register for the seminar and receive a €100 discount on the e-learning programme (€390 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
390,00 €
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 Volker Blust
Dr Meike Harms
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
Dr Bernd-Bodo Haas
Dr Matthias Germer
Dr Bernd-Bodo Haas
Dr Bernd-Bodo Haas
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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