2023-06-08 2023-06-08 , online online, 2,590 € plus tax Prof. Dr. Michael Arand https://www.forum-institut.com/seminar/23072470-toxicology-summer-school/referenten/23/23_07/23072470-online-training-course-pharma-toxicology-summer-school_arand-michael.jpg Toxicology Summer School

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.

Topics

Toxicokinetics and drug-drug interaction
Mutagenicity and genotoxicity, carcinogenicity
Reproductive toxicity and safety pharmacology
Immunotoxicity/Immunogenicity
Risk assessment and risk communication

Who should attend

This Summer School addresses the need for solid toxicological know-how of employees in the pharmaceutical industry, particularly those in the following departments:

Research and development
Medical affairs
Regulatory affairs
Pharmacovigilance

Basic scientific knowledge would be helpful, toxicological know-how is not expected.

Aims and objectives

During this Summer School

you will build a solid toxicological know-how basis;
you will get to know the essential toxicological modes of action and learn how to apply them to your products;
you will receive good insights into the toxicological study programme and learn how it must be scheduled in drug development;
you will be informed about the inclusion of toxicological data in the marketing authorisation dossier and the associated regulatory affairs duties.

To make the most of your seminar attendance, you may submit your individual questions or cases to Birgit Wessels (b.wessels@forum-institut.de) two weeks prior to the event.

Your benefit

Know-how for employees in R&D, Medical Affairs, Regulatory Affairs & Pharmacovigilance - no toxicological know-how is expected.
Essential toxicological modes of action will be taught and the inclusion of the data in the marketing authorisation dossier will be adressed.
Experts with a toxicological background and a regulatory affairs background will answer your questions in detail

Toxicology
Summer School

- Online training -

Benefits

Detailed documentation
First-hand information
Profit from different perspectives: Authority vs industry
Pose your individual questions in advance
We are following the IMI quality criteria

Webcode 23072470

Book now

JETZT Buchen

Speakers

Everything at a glance

Appointment

04-06/07/2023

Period

Day I+II: 9:00 am - 5:00 pm - semina...

Day I+II: 9:00 am - 5:00 pm - seminar
Day III: 9:00 am - 4:30 pm - seminar
You may dial in 30 minutes before the training starts

Venue

online

Downloads

Fee

Inhouse-offers

Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Topics

Toxicokinetics and drug-drug interaction
Mutagenicity and genotoxicity, carcinogenicity
Reproductive toxicity and safety pharmacology
Immunotoxicity/Immunogenicity
Risk assessment and risk communication

Who should attend

This Summer School addresses the need for solid toxicological know-how of employees in the pharmaceutical industry, particularly those in the following departments:

Research and development
Medical affairs
Regulatory affairs
Pharmacovigilance

Basic scientific knowledge would be helpful, toxicological know-how is not expected.

Aims and objectives

During this Summer School

you will build a solid toxicological know-how basis;
you will get to know the essential toxicological modes of action and learn how to apply them to your products;
you will receive good insights into the toxicological study programme and learn how it must be scheduled in drug development;
you will be informed about the inclusion of toxicological data in the marketing authorisation dossier and the associated regulatory affairs duties.

To make the most of your seminar attendance, you may submit your individual questions or cases to Birgit Wessels (b.wessels@forum-institut.de) two weeks prior to the event.

Your benefit

Know-how for employees in R&D, Medical Affairs, Regulatory Affairs & Pharmacovigilance - no toxicological know-how is expected.
Essential toxicological modes of action will be taught and the inclusion of the data in the marketing authorisation dossier will be adressed.
Experts with a toxicological background and a regulatory affairs background will answer your questions in detail

Detailed programme

Day I+II: 9:00 am - 5:00 pm - seminar
Day III: 9:00 am - 4:30 pm - seminar
You may dial in 30 minutes before the training starts

09:00 Welcome, expectations, introduction

09:15

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

10:15 Coffee break

10:30

Prof Dr Michael Arand

Pharmacokinetics and toxicokinetics (continued)

11:45 Lunch break

12:45

Prof Dr Michael Arand

Drug-drug interactions

13:30

Dr Bernd-Bodo Haas

General principles

In vivo/in vitro studies
Acute versus chronic toxicity; single dose versus repeat dose toxicity
Toxicological endpoints
Upcoming changes in ICH guidelines for preclinical safety
ICH guidelines with non-clinical aspects

15:30 Coffee break

15:45

Dr Bernd-Bodo Haas

Toxicological studies in a regulatory affairs context

Prerequisites for first-in-human studies

17:00 End of training day 1

09:00

Dr B.-B. Haas, 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 B.-B. Haas, Dr H.-J. Martus