2021-12-04 2022-07-06 , online online, 2.590,- € plus tax Prof. Dr. Michael Arand https://www.forum-institut.com/seminar/22072470-toxicology-summer-school/referenten/22/22_07/22072470-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
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.
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.

Online course: Toxicology Summer School

Toxicology
Summer School

- Online training -

Benefits
  • Detailed documentation
  • First-hand information from experts
  • Pose your individual questions in advance
  • Online format: modern, flexible, interactive
  • We are following the IMI quality criteria

Webcode 22072470

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

04. - 06.07.2022

04. - 06.07.2022

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

online

Fee
Your contact person

Dr. Birgit Wessels
Conference Manager

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

Details

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
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.

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.

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

Mutagenicity and genotoxicity (continued)

11:30

Dr Bernd-Bodo Haas

Photosafety evaluation

12:15 Lunch break


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 training day 2


09:00

Dr Anika Schröter

Deviating from standard requirements: A reduced non-clinical programme
  • Overview of a standard toxicological programme
  • The value of publicly available data/ literature searches
  • What is the 3Rs principle and when shall it be applied
  • Excursion: Authority interactions/ scientific advice
  • Case studies: When, why and how to skip In vivo studies

10:30 Coffee break


10:45

Dr Anika Schröter

Risk assessment and risk communication
  • The dark side of speeding up the non-clinical development
  • Examples that triggered changes in regulatory requirements
  • Risk-based approach: ATMPs as an example

12:30 Lunch break


13:30

Dr Niklas Czeloth

Immunotoxicity
  • The principles of the ICH S8 guideline
  • Points to consider in immunotox. studies
  • Examples of immunotoxicology effects

15:45 Outstanding questions and concluding discussion


More information

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

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

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Your feedback produced as result of 1.8 in 2021. Thank you!

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Testimonials

This was well received by the participants in January 2018
Good selection of speakers


The whole seminar was very useful


Clear, complete, practical examples


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