165 Simcyp Focused Workshop: Bridging Bottom-Up and Top-Down PBPK Approaches: Sensitivity Analysis and UQ for Regulatory Applications (PEPD) - July 13-17, 2026 | ONLINE

Content
8 modules
Course length
0 mins
Instructor
Kelly Turton
Released
22 Oct 2025
Price
£1,450.00

Description

July 13-17, 2026 | ONLINE

Bridging Bottom-Up and Top-Down PBPK Approaches: Sensitivity Analysis and UQ for Regulatory Applications

The recent ICH M15 Model-Informed Drug Development (MIDD) guidance outlines regulatory expectations for the development, evaluation, and application of mechanistic models. This workshop focuses on PBPK model development and performance assessment, with particular emphasis on sensitivity analysis, parameter estimation, and uncertainty quantification (UQ) in a regulatory context.

Participants will learn how sensitivity analysis can support model development, identify influential parameters, and inform confidence in model predictions. Key principles and practical implementation of uncertainty quantification will be introduced as part of PBPK model evaluation, alongside strategies for bridging bottom-up and top-down.

The workshop demonstrates how in vitro data, physiological knowledge, and clinical observations can be integrated to refine uncertain model parameters. Delegates will explore sensitivity analysis tools, parameter estimation workflows using clinical data, and the use of the Simcyp-R package for running simulations and analyzing model outputs in R. An overview of pharmacodynamic models available within the Simulator will also be provided, illustrating their integration with PBPK modeling.

The course is delivered as through a combination of lectures and tutor led interactive examples sessions.

Live Online Courses

There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.

Objectives

Key aspects covered in this course: 

  • The theoretical basis for combining bottom-up and top-down modelling and simulation that meets regulatory requirements
  • Sensitivity Analysis   
    • Workflow
    • Local methods: PK profiles, parametric scanning and population SA
    • Global methods including meta-modelling approaches
  • Parameter estimation: 
    • Step-by step guidance on data entry, fitting, and interpretation of results 
    • Simultaneous fitting of PK and PD parameters 
    • Covariate recognition 
  • Simcyp R:
    • Technical details on the R package and it’s capabilities
    • Scripts for key tasks
  • Uncertainty Quantification
    • Principal of uncertainty quantification for DDI
    • Applications in regulatory applications          
  • Pharmacodynamics: 
    • Models available 
    • Use of preliminary clinical data to model and simulate various covariate effects (e.g., genotypic/phenotypic differences, effects of diseases such as renal impairment or cirrhosis) 
    • PD at the relevant effect site (e.g., liver) 
  • Options for user-defined PD models 

Certificate

By completing/passing this course, you will attain the certificate PEPD 2025

1.
Pre Course Questionnaire - Your experience, expectations and area of interest, an optional survey to take prior to the course
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2.
PEPD Agenda - July 13-17, 2026
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3.
Pre Recorded Introductions to the Simcyp Simulator
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4.
Simcyp Simulator Download instructions (Amazon Workspaces download)
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5.
Slide Decks and Files for Loading
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6.
Hands on Materials / Questions & Answers
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7.
Presentation and Office Hour Recordings
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8.
Survey, please complete for Certificate of completion
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User Accounts and Registrations

The email address used for your user login must be an individual account.  No sharing of user accounts between multiple individuals is allowed.  Each user account (and any associated course registrations) is for a specific person, and cannot be transferred to a different individual once the course has started.  

Course Materials

As a course registrant, you may view and read all materials related to your registered courses. However, you may not share, communicate, publish, copy or in any manner distribute to other parties the course materials, reference material provided, assignment solutions, quiz questions, exam questions, links or any other materials. 

Cancellation Policy

Live Online Courses

There are no refunds for Live Online courses for cancellation or non-attendance by the participant.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.

e-Learning and Certifications

There are no refunds for e-Learning courses or certifications.  Course expiration dates can be found on your Dashboard.

Electronic Communication

We will send you email notifications regarding your training courses, including enrollment confirmations, purchase confirmations, and reminders of upcoming sessions.  We will also send email for general announcements about the site.  You can opt out of these emails if you wish (located in your profile).

Details

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