2024-12-21 2024-12-21 , online online, 1,990 € zzgl. MwSt. Prof. Dr. Michael Arand https://forum-institut.de/seminar/25022471-toxicology-and-beyond-safety-assessment-in-drug-development/referenten/25/25_02/25022471-toxicology-and-beyond-safety-assessment-in-drug-development_arand-michael.jpg Toxicology and beyond: Safety assessment in drug development

During our online training "Toxicology and beyond: Safety assessment in drug development" 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
  • Pharmacokinetics and toxicokinetics
  • Safety pharmacology and photosafety evaluation
  • Genotoxicity, carcinogenicity, reproductive toxicology, immunotoxicity
  • Challenges in regulatory-complaint toxicology programs


Who should attend
The target audience for this training comprises toxicologists, preclinical safety manager, scientific researcher, regulatory affairs manager ... actively involved in pharmaceutical development. Professionals that play a crucial role in assessing the safety and efficacy of drugs, ensuring their compliance with regulatory standards.

By the end of this training, you will have gained specialized knowledge to excel your role, confidently addressing complex challenges in toxicology programs.
Aims and objectives
  • This training aims to equip you - toxicologists, preclinical safety manager, scientific researcher ... - with essential knowledge and practical insights to enhance your expertise in drug development and safety evaluation.

  • You will be proficient in pharmacokinetics and toxicokinetics, grasp general principles, master photosafety evaluation, navigate safety pharmacology, interpret genotoxicity data, assess carcinogenicity risks, delve into reproductive toxicology, explore immunotoxicity, and confidently address the challenges inherent in regulatory-compliant toxicology programs.

  • The focus is on imparting scientific/fundamental knowledge in conjunction with application-oriented approaches.
Your benefit

  • During this training, participants will gain a comprehensive understanding of key topics relevant to drug safety assessment.
  • The aim is to equip you as participant with fundamental (scientific) toxicological knowledge.

Toxicology and beyond: Safety assessment in drug development

Toxicology and beyond:
Safety assessment in drug development

- Online training -

Benefits
  • First-hand information
  • Profit from different perspectives: authority, industry, research institutions, your colleagues from the industry
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25022471

Jetzt buchen

JETZT Buchen
Referenten

Prof. Dr. Michael Arand

Institute of Pharmacology and Toxicology, University of Zurich, SWITZERLAND

Professor in the Institute for Pharmacology and Toxicology

Dr. Bernd-Bodo Haas

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.

Dr. Hans-Joerg Martus

Novartis Institutes for BioMedical Research (NIBR), Basel, SWITZERLAND

Head of Genome Safety and Project Toxicologist

Dr. Niklas Czeloth

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, GERMANY

He is an Investment Manager in the Boehringer Ingelheim Venture Fund with 15 years of experience in pharmaceutical development.

Dr. Anika Schröter

Dr. Anika Schroeter e.U., Vienna, AUSTRIA

Anika Schröter holds a PhD in toxicology and is a registered European Registered Toxicologist. Since 2014 she has been working as a consultant for clients in the pharmaceutical and biotech industry on issues related to non-clinical drug development (e.g. small molecules, biologics, vaccines). Her expertise includes the creation of non-clinical development programs, design and supervision of GLP toxicology studies, or support in consultations with European or non-European authorities. Since 2021 she runs her own consulting company in Vienna.

Alles auf einen Blick

Termin

17-18/02/2025

17-18/02/2025

Zeitraum

Both days: 9:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

Both days: 9:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

During our online training "Toxicology and beyond: Safety assessment in drug development" 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

  • Pharmacokinetics and toxicokinetics
  • Safety pharmacology and photosafety evaluation
  • Genotoxicity, carcinogenicity, reproductive toxicology, immunotoxicity
  • Challenges in regulatory-complaint toxicology programs


Who should attend
The target audience for this training comprises toxicologists, preclinical safety manager, scientific researcher, regulatory affairs manager ... actively involved in pharmaceutical development. Professionals that play a crucial role in assessing the safety and efficacy of drugs, ensuring their compliance with regulatory standards.

By the end of this training, you will have gained specialized knowledge to excel your role, confidently addressing complex challenges in toxicology programs.

Aims and objectives

  • This training aims to equip you - toxicologists, preclinical safety manager, scientific researcher ... - with essential knowledge and practical insights to enhance your expertise in drug development and safety evaluation.

  • You will be proficient in pharmacokinetics and toxicokinetics, grasp general principles, master photosafety evaluation, navigate safety pharmacology, interpret genotoxicity data, assess carcinogenicity risks, delve into reproductive toxicology, explore immunotoxicity, and confidently address the challenges inherent in regulatory-compliant toxicology programs.

  • The focus is on imparting scientific/fundamental knowledge in conjunction with application-oriented approaches.

Your benefit

  • During this training, participants will gain a comprehensive understanding of key topics relevant to drug safety assessment.
  • The aim is to equip you as participant with fundamental (scientific) toxicological knowledge.

Detailed programme

Both days: 9:00 am - 5:00 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

Dr Bernd-Bodo Haas

General principles
  • Pharmacology vs Toxicology and selection of the relevant species
  • Repeat-dose toxicity: toxicological descriptors and safety margins
  • Timing of toxicity studies (ICH M3(R2))
  • Prerequisites for first-in-human studies
  • ICH guidelines with non-clinical aspects

Including a coffee break of about 15 minutes.

15:30

Dr Bernd-Bodo Haas

Photosafety evaluation

16:15

Dr Bernd-Bodo Haas

Safety pharmacology
  • Disciplines of safety pharmacology
  • Regulatory principles and guidelines
  • Cardiovascular safety pharmacology

17:00 Q&As and end of training day 1


09:00

Dr Hans-Joerg Martus

Genotoxicity
  • Test systems and test strategies
  • ICH S2
  • Guidance ICH M7
  • Case studies

10:30 Coffee break


10:45

Dr Hans-Joerg Martus

Carcinogenicity
  • Principles of carcinogenicity testing
  • Regulatory guidances
  • Transgenic animals
  • Case studies

11:45

Dr Hans-Joerg Martus

Reproductive toxicology
  • Reproductive toxicity testing
  • Regulatory guidances

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
  • Immunogenicity

15:00 Coffee break


15:15

Dr Anika Schröter

Challenges in regulatory-complaint toxicology programs
  • Overview of a standard toxicological program
  • Case studies: when, why and how to skip In-vivo studies
  • The value of publicly available data/ literature searches
  • What is the 3Rs principle and when shall it be applied
  • Excursion: authority interactions/scientific advice
  • The dark side of speeding up the non-clinical development
  • Examples that triggered changes in regulatory requirements
  • Risk-based approach: ATMPs as an example

16:45 Q&As


17:00 End of training day 2


More information

Benefits of a FORUM Institut training course

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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  • High level of interactivity with plenty of opportunity for questions
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You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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