Toxicology Summer School
Seminar
Online
Beschreibung
-
Kursart
Seminar
-
Methodik
Online
During this Summer School you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Inhalte
Detailed programme
Day 1: 09:00 - 17:00 seminar
Day 2: 09:00 - 17:00 seminar
Day 3: 09:00 - 16:00 seminar
09:00
Prof Dr Michael Arand
Pharmacokinetics and toxicokinetics
- The mechanistic basis ADME (absorption, distribution, metabolism, excretion)
- Species differences
- Polymorphisms as the basis for interindividual variability
- Enzyme induction/inhibition as the basis for intraindividual variability
- Biological activity of metabolites
- In vitro versus in vivo studies - pros and cons
10:00 Coffee break
10:15
Prof Dr Michael Arand
Pharmacokinetics and toxicokinetics
(continued)
11:30 Lunch
12:45
Prof Dr Michael Arand
Drug-drug interactions
13:30
Dr Susanne Brendler-Schwaab
General principles
- In vivo/in vitro studies
- Acute versus chronic toxicity; single dose versus repeat dose toxicity
- Toxicological endpoints
- Upcoming changes in the ICH guidelines
- Additional ICH guidelines with non-clinical aspects
15:30 Coffee break
15:45
Dr Susanne Brendler-Schwaab
Toxicological studies in a regulatory affairs context
- Prerequisites for first-in-human studies
17:00 End of day 1
09:00
Dr S. Brendler-Schwaab, Dr H.-J. Martus
Mutagenicity and genotoxicity
- Test Systems and test Strategies
- ICH S2 - Guidance on Specific Aspects of Regulatory Genotoxicity Tests
- Guidance ICH M7 - Assessment and Control of DNA Reactive Impurities
- Case studies
10:30 Coffee break
10:45
Dr S. Brendler-Schwaab, Dr H.-J. Martus
Mutagenicity and genotoxicity (continued)
11:30
Dr Susanne Brendler-Schwaab
Photosafety evaluation
12:15 Lunch
13:15
Dr Hans-Joerg Martus
Carcinogenicity
- Principles of carcinogenicity testing
- Regulatory guidances
- Transgenic animals
- Case studies
15:00 Coffee break
15:15
Dr Hans-Joerg Martus
Reproductive toxicology
- Principles of reproductive toxicity testing
- Regulatory guidances
16:00
Dr Hans-Joerg Martus
Safety pharmacology
- Disciplines of safety pharmacology
- Regulatory principles and guidelines
- Cardiovascular safety pharmacology
17:00 End of day 2
09:00
Dr Niklas Czeloth
Immunotoxicity
- Immunotoxicity - the basics
- The principles of the ICH S8 guideline
- Points to consider in immunotoxicology studies
- Examples of immunotoxicology effects
11:15 Coffee break
...Toxicology Summer School