Workshop: An introduction to probabilistic decisions support in drug development

Are you looking to improve decision making in drug development? This workshop introduces how Model-Informed-Drug-Development (MIDD) principles can be applied to facilitate probability-based decision making in drug development. Pharmetheus host this satellite workshop on the 25th of June in conjunction to PAGE.

Workshop overview

The workshop covers a number of relevant concepts such as power, assurance, probability of pharmacological success (PoPS), probability of technical success (PTS), and probability of technical and regulatory success (PTRS). Important requirements for the basis of such probability predictions, including fit-for-purpose models and clinical trial simulations, are also highlighted. In addition to basic theory, with regards to these topics, the workshop includes relevant case-studies and practical recommendations on efficient communication of MIDD approaches from tutors with extensive experience in this area.

Workshop learning objectives

The workshop covers:

  • MIDD and the current state of affairs for pharmaceutical R&D
  • Working with a Target Product Profile
  • Definition of decision criteria & Go/No-go
  • Economic risk analysis
  • Characterization and simulation of variability and uncertainty
  • Introduction of probability concepts (e.g. power, assurance, PoPS, PTS and PTRS)
  • Clinical Trial Simulation

Workshop target audience

The target audience are scientists with a modeling and/or statistics background who have a basic understanding of the overall drug development process. You need to bring a laptop or tablet if you want to take active part in hands-on exercises (no special software installation needed).

Workshop tutors

In addition to the ordinary program the Pharmetheus tutors would be happy to schedule shorter individual free speed-consulting sessions in association to this workshop to support the participants on related topics.

Workshop logistic details

Date: Tuesday 25th June, 2024

Time: 09:00 – 17:00

Place: Ergife Palace Hotel & Conference Center

Registration Fee

Fee: € 600 excl. VAT (a limited number of seats are reserved for students @ € 150 excl. VAT)

The fee includes coffee breaks and lunch.

    Use the form below to book your attendance to the workshop.

    Please note that available slots are limited.
    We will get back to you with more information and payment details.

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