COURSE: Modelling & Simulation for non-modellers
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Course Duration: 1.5 Days
About This Course
Modelling & Simulation plays a vital role in today’s drug development process; its importance will only increase. Successful implementation of Modelling & Simulation is teamwork, bringing together people with different backgrounds. But these people do not always speak the language of Modelling & Simulation. This may result in miscommunication, expectations that cannot be met or delivery of a sub-optimal Modelling & Simulation package. This course will help you to understand the concepts of Modelling & Simulation and how to use it in your drug development process.
Why You Should Attend
- To learn what Modelling & Simulation is
- To learn about the various types of modelling
- To learn interpreting Modelling & Simulation results
- To understand the role of modelling and simulation in the drug development proces
- To understand how Modelling & Simulation should be implemented in your processes
- To understand the team responsibilities in different phases of the drug development process
- To learn what the FDA and EMA say about Modelling & Simulation
By the end of this course, you will:
- Be able to talk with our modellers, discuss your expectations, understand what the requirements are to meet these expectation
- Be able to understand the importance of Modelling & Simulation results
- Understand the importance of Modelling & Simulation in the drug development process
- Pharmacokinetic and Pharmacodynamic refresher
- What is modelling
- Modelling applications
- Regulatory aspects
Who Should Attend / Who is the course for?
- Clinical pharmacologists interested in learning the use of modelling in early clinical studies.
- Project team leaders, to have an overall view of how modelling can be strategically used and how it should be implemented in an overall development plan
- Pre-clinical ADME scientists and pharmacologists, involved in the design of the first in human study.
- Statisticians, to understand how modelling can be optimally used in clinical development.
- Regulatory experts, since modelling is increasingly used in submissions.
- Medical scientists (i.e. people designing phase 2 / 3 studies), as phase 2 and 3 studies are very important for collecting data for modelling.
- Medical writers, as understanding of the concepts and use of modelling will help you in writing higher quality documents more quickly.
Please be aware that this is not a course that will teach you how to use Modelling & Simulation software or how to programme your own models. In short, this is a modelling course for non-modellers.
The course is presented by our Modelling experts :
- Rüdiger Kaspera