Pharmacokinetic and Pharmacodynamic (PK/PD) Modelling

From core concepts to practical application, including therapeutic proteins and monoclonal antibodies

  • Expert speaker faculty
  • Industry + authority perspective
  • Real-world data examples
  • Hands-on practical exercises
  • Latest industry developments
  • Officially certified: ISO 9001 + 21001

Online-Seminar

Ab 1.990,00 € zzgl. MwSt.
Leistungen & Ablauf

Buchungsdetails

Online-Seminar

Ab 1.990,00 € zzgl. MwSt.
Leistungen & Ablauf

You want to be able to discuss pharmacokinetic and pharmacodynamic modelling with your colleagues more confidently? This seminar gives you the know-how, from compartment models and preclinical-to-clinical translation to the specific characteristics of therapeutic proteins and monoclonal antibodies, combined with hands-on practical exercises.

Your speakers

Dr. Andreas Becker

Dr. Andreas Becker

Merck KGaA

Global Early Development Lead

Dr. Gilbert Koch

Dr. Gilbert Koch

Pediatric Clinical Pharmacology, University Children’s Hospital Basel, SWITZERLAND

Senior Research Fellow in Modeling and Simulation
Dr G. Koch is an interdisciplinary scientist specialized in…

Dr. Elke Stahl

Dr. Elke Stahl

Preclinical & Pharmacokinetics Expert, Bonn

Preclinical & Pharmacokinetics Expert

Dr. Britta Steffens

Dr. Britta Steffens

Pediatric Clinical Pharmacology, University Children’s Hospital Basel, SWITZERLAND

Scientific Researcher
Dr Steffens is an interdisciplinary scientific researcher with mathematical and statistical…

Dr. Niklas Czeloth

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.

What to Expect

  • Core concepts of pharmacokinetic (PK) and pharmacodynamic (PD) modelling
  • Translation from preclinical to clinical trials
  • Practical application of PK/PD models using real data examples
  • Special PK/PD aspects of therapeutic proteins and monoclonal antibodies, including drug-drug interactions

Who Should Attend

This seminar is designed for professionals in drug development who want to understand the concepts and results of PK/PD modelling, whether or not they are directly involved in the modelling work themselves, for example from clinical development, regulatory affairs, project management, or drug safety.

It is equally suited to scientists moving into a role with closer contact to PK/PD modelling and to anyone who wants to engage confidently with colleagues working in this field.

Objective of the Event

This seminar provides the foundations in pharmacokinetics and pharmacodynamics needed to follow and contribute to PK/PD modelling work, covering key parameters, compartment models, and the translation of preclinical data into the first-in-human trial.

As participant you learn assessing current developments in the field and engaging with internal PK/PD projects, whether as a contributor or as a colleague working alongside the modelling team.

Practical exercises let you apply a PK/PD model to real data yourself, building the confidence to discuss modelling approaches with colleagues in the field. The program also addresses the specific pharmacokinetic characteristics of therapeutic proteins and monoclonal antibodies, including immunogenicity and drug-drug interactions, which are increasingly relevant in current drug development.

Your Benefit

  • You will be able to follow and contribute to internal PK/PD projects with a solid understanding of the underlying concepts and methods.
  • You will gain the confidence to discuss modelling approaches and results with colleagues working in PK/PD modelling, on equal footing.
  • You will experience through hands-on exercises, how a PK/PD model is applied to real data, giving you a practical sense of what the analysis involves.
  • You will understand the specific PK/PD characteristics of therapeutic proteins and monoclonal antibodies, which are increasingly relevant across current drug development projects.

Programme

Day 1+2 from 9:00 a.m. - 5:00 p.m.
CET - Online training

Day 1

Welcome, introduction, expectations
Dr. Andreas Becker

Parameters of model-independent pharmacokinetics
Dr Andreas Becker
  • Exposure parameters
  • Bioavailability
  • Dose proportionality

Basic knowledge of pharmacokinetics modelling
Dr Britta Steffens, Dr Gilbert Koch
  • Basic concept of compartment models
  • Transport processes and elimination
  • Analysis methods and software tools

From the target to the first in human trial (FIH)
Dr Elke Stahl
  • Preclinical studies on pharmacology and safety
  • Dose selection - starting dose for the first clinical trial

Pharmacokinetic studies in drug development
Dr Andreas Becker
  • Clinical pharmacology package for the authorisation of a new active substance
  • General consideration on study designs
  • Examples

Recap and questions

End of seminar day I

Welcome, introduction, expectations

Parameters of model-independent pharmacokinetics

Dr Andreas Becker

  • Exposure parameters
  • Bioavailability
  • Dose proportionality

Basic knowledge of pharmacokinetics modelling

Dr Britta Steffens, Dr Gilbert Koch

  • Basic concept of compartment models
  • Transport processes and elimination
  • Analysis methods and software tools

From the target to the first in human trial (FIH)

Dr Elke Stahl

  • Preclinical studies on pharmacology and safety
  • Dose selection - starting dose for the first clinical trial

Pharmacokinetic studies in drug development

Dr Andreas Becker

  • Clinical pharmacology package for the authorisation of a new active substance
  • General consideration on study designs
  • Examples

Recap and questions

End of seminar day I

Day 2

Population pharmacokinetics
Dr Britta Steffens, Dr Gilbert Koch
  • Principles of population pharmacokinetics
  • Covariate models
  • Analysis strategies and good modeling practice

Introduction to pharmacokinetics/pharmacodynamics modelling
Dr Britta Steffens, Dr Gilbert Koch
  • Saturation models, e.g. Emax models
  • Linking pharmacokinetics and pharmacodynamics through response models

Pharmacokinetics/pharmacodynamics analyses using practical examples
D. Britta Steffens, Dr Gilbert Koch, Dr Andreas Becker

Using simple tools, participants will be shown and given the opportunity to practise how to analyse data from PK/PD studies, i.e. how to apply a PK/PD model (2 examples).

Special features of the pharmacokinetics of therapeutic proteins
Dr Niklas Czeloth
  • Structure, function and pharmacokinetics of proteins
  • Pharmacokinetics of monoclonal antibodies

The relationship between pharmacokinetics and pharmacodynamics - the example of monoclonal antibodies
Dr Niklas Czeloth
  • The influence of immunogenicity on PK
  • Dose-response and concentration-response relationships
  • Suitable markers for efficacy and safety

Therapeutic proteins and pharmacokinetic drug-drug interactions
Dr Niklas Czeloth
  • Drug-drug interactions (DDI) involving therapeutic proteins

Recap and questions

Population pharmacokinetics

Dr Britta Steffens, Dr Gilbert Koch

  • Principles of population pharmacokinetics
  • Covariate models
  • Analysis strategies and good modeling practice

Introduction to pharmacokinetics/pharmacodynamics modelling

Dr Britta Steffens, Dr Gilbert Koch

  • Saturation models, e.g. Emax models
  • Linking pharmacokinetics and pharmacodynamics through response models

Pharmacokinetics/pharmacodynamics analyses using practical examples

D. Britta Steffens, Dr Gilbert Koch, Dr Andreas Becker

Using simple tools, participants will be shown and given the opportunity to practise how to analyse data from PK/PD studies, i.e. how to apply a PK/PD model (2 examples).

Special features of the pharmacokinetics of therapeutic proteins

Dr Niklas Czeloth

  • Structure, function and pharmacokinetics of proteins
  • Pharmacokinetics of monoclonal antibodies

The relationship between pharmacokinetics and pharmacodynamics - the example of monoclonal antibodies

Dr Niklas Czeloth

  • The influence of immunogenicity on PK
  • Dose-response and concentration-response relationships
  • Suitable markers for efficacy and safety

Therapeutic proteins and pharmacokinetic drug-drug interactions

Dr Niklas Czeloth

  • Drug-drug interactions (DDI) involving therapeutic proteins

Recap and questions

Downloads

Request the documents using our form.

Abbreviation List Biotech

Further Informations


In-house seminars: Advanced training tailor-made!

You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!

We also offer this seminar as an in-house seminar.

Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.

We will be happy to send you a non-binding offer.


Modular qualification course to become "Development Experts Biologics"

This seminar is elective module of our qualification course to become a "Development Experts Biologics.

The program structure:

  • You will attend our basic course "Biopharmaceuticals" (day I+II

; day III is an elective module)

  • Afterward, you’ll participate in 3 additional elective seminar modules (= 3 seminar days), which you’ll select individually from the program curriculum
  • You’ll receive structured professional development and comprehensive knowledge on topics related to the development and manufacture of biologics
  • You can specialise by selecting seminars tailored to your specific area of focus


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


Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.


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.

In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

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All about ATMP

DAS Online-Seminar zu den Themen Entwicklung, Qualität, CMC, Zulassung und Market Access für ATMPs/Gentherapeutika. Profitieren Sie vom Austausch mit langjähring erfahrenen Expert*innen aus Behörde…
Sprache: Deutsch
19. - 20.10.2026
Online-Seminar
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Further Information

We guarantee the highest quality

We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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e-Learning - Click and learn

e-Learning - Click and learn

We provide flexible education and training with high-quality e-Learning programmes for several topics.

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More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.

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Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Dr. Birgit Wessels

Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de