Toxicology and beyond: Safety assessment in drug development
Know-how for employees in R&D, Medical affairs, Regulatory affairs & Pharmacovigilance - no toxicological know-how is expected
- 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
Online-Seminar
From
2.090,00 €
plus VAT
Services & Process
Veranstaltung - 2.090,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Both days: 9:00 am - 5:00 pm CET - Online training
You may dial in 30 minutes before the training starts
Booking details
Online-Seminar
From
2.090,00 €
plus VAT
Services & Process
Veranstaltung - 2.090,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Both days: 9:00 am - 5:00 pm CET - Online training
You may dial in 30 minutes before the training starts
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.
Your speakers
Prof. Dr. Michael Arand
Institute of Pharmacology and Toxicology,
University of Zurich, SWITZERLAND
Professor in the Institute for Pharmacology and Toxicology
Your speaker
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
Toxicology Expert,
Bonn, GERMANY
Specialist in Genetic and Reproductive Toxicology
He works at the Genetic and Reproductive Toxicology, Bundesinstitut für Arzneimittel und Medizinprodukte and does…
Your speaker
Dr. Bernd-Bodo Haas
Toxicology Expert,
Bonn, GERMANY
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. 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.
Your speaker
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. Hans-Joerg Martus
Novartis Institutes for BioMedical Research (NIBR),
Basel, SWITZERLAND
Head of Genome Safety and Project Toxicologist
Your speaker
Dr. Hans-Joerg Martus
Novartis Institutes for BioMedical Research (NIBR),
Basel, SWITZERLAND
Head of Genome Safety and Project Toxicologist
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…
Your speaker
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.
What to Expect
- 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.
Objective of the Event
- 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.
Programme
each day from 09:00 am - 05:00 pm Online-training
Day 1
09:00
09:15
Prof Dr Michael Arand
- 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
10:30
Prof Dr Michael Arand
11:45
12:45
Dr Bernd-Bodo Haas
- 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
16:15
Dr Bernd-Bodo Haas
- Disciplines of safety pharmacology
- Regulatory principles and guidelines
- Cardiovascular safety pharmacology
17:00
Welcome, expectations, introduction
09:15
Pharmacokinetics and toxicokinetics
Pharmacokinetics and toxicokinetics
Prof Dr Michael Arand
- 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
Coffee break
Pharmacokinetics and toxicokinetics (continued)
Lunch break
12:45
General principles
General principles
Dr Bernd-Bodo Haas
- 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.
Photosafety evaluation
16:15
Safety pharmacology
Safety pharmacology
Dr Bernd-Bodo Haas
- Disciplines of safety pharmacology
- Regulatory principles and guidelines
- Cardiovascular safety pharmacology
Q&As and end of training day 1
Day 2
09:00
Dr Hans-Joerg Martus
- Test systems and test strategies
- ICH S2
- Guidance ICH M7
- Case studies
10:30
10:45
Dr Hans-Joerg Martus
- Principles of carcinogenicity testing
- Regulatory guidances
- Transgenic animals
- Case studies
11:45
Dr Hans-Joerg Martus
- Reproductive toxicity testing
- Regulatory guidances
12:30
13:30
Dr Niklas Czeloth
- The principles of the ICH S8 guideline
- Points to consider in immunotox. studies
- Examples of immunotoxicology effects
- Immunogenicity
15:00
15:15
Dr Anika Schröter
- 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
17:00
09:00
Genotoxicity
Genotoxicity
Dr Hans-Joerg Martus
- Test systems and test strategies
- ICH S2
- Guidance ICH M7
- Case studies
Coffee break
10:45
Carcinogenicity
Carcinogenicity
Dr Hans-Joerg Martus
- Principles of carcinogenicity testing
- Regulatory guidances
- Transgenic animals
- Case studies
11:45
Reproductive toxicology
Reproductive toxicology
Dr Hans-Joerg Martus
- Reproductive toxicity testing
- Regulatory guidances
Lunch break
13:30
Immunotoxicity
Immunotoxicity
Dr Niklas Czeloth
- The principles of the ICH S8 guideline
- Points to consider in immunotox. studies
- Examples of immunotoxicology effects
- Immunogenicity
Coffee break
15:15
Challenges in regulatory-complaint toxicology programs
Challenges in regulatory-complaint toxicology programs
Dr Anika Schröter
- 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
Q&As
End of training day 2
Downloads
Request the documents using our form.
Brochure
Whitepaper_Stability-Testing-of-Drug-Products
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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.
- Live and interactive learning on our Learning Space training platform
- A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
- Easy surveys with Slido
- ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
- A central repository for documents and media
- Other services and apps such as Padlet and Mentimeter available directly on the platform
- The perfect marriage of teaching methods and technology
- High level of interactivity with plenty of opportunity for questions
- Continuous support throughout the event to ensure the most effective learning
- Free technical pre-meeting to start off your training on the right foot
Free pre-meeting and technology check
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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Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de