Digital CMC Regulatory Lifecycle (DCRL) Framework & Workflow
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This course covers the framework and associated workflow for the Digital CMC Regulatory Lifecycle (DCRL) of computational models, including AI. The DCRL framework and workflow was developed by the Digital CMC CERSI, to serve as the basis for a harmonised approach and support predictable, proportionate, and regulator-ready adoption of computational models in Chemistry, Manufacturing and Controls (CMC). The DCRL workflow provides a structure for defining context of use, credibility assessment expectations, lifecycle controls, and documentation that is consistent with emerging regulatory guidance, standards, research papers, and white papers from industry and professional associations.
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An Overview of CERSI Training Courses and Course-Specific Learning Objectives
Introduction
Computational Model Landscape
DCRL Framework
DCRL Workflow: An Overview
Concept & Risk Analysis
Stage 1: Define the Question of Interest
Stage 2: Define the Context of Use
Stage 3: Conduct Risk Assessment
Development & Verification
Stage 4: Plan Data Collection
Stage 5: Model Development, Data Collection, and Credibility Assessment
Step 5a: Describe the Model
Step 5b: Describe the Data Used to Develop the Model
Validation & Uncertainty Quantification
Step 5c: Describe Model training, Parameterisation and/or Calibration
Step 5d: Describe the Model Evaluation Process
Stage 6: Review the Credibility Assessment
Stage 7: Model Credibility Assessment Decision and Reporting
Regulatory Use & Lifecycle Management
Stage 8: Assessing Regulatory Documentation Requirements
Stage 9: Document Model for Regulatory Submission or Inspection
Stage 10: Lifecycle Management
DCRL Workflow: A High Level Review and Context within the DCRL Framework
End of Module Quiz
References
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Gain an understanding of what the DCRL framework is and how it applies to computational models
Understand the landscape of computational models, including AI
Understand the individual stages of the DCRL workflow
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Pharmaceutical professionals, regulatory affairs professionals, regulators and researchers who want to understand and apply the Digital CMC Regulatory Lifecycle framework and workflow.
This course is delivered by CMAC’s Digital CMC CERSI team.
Available now
Format: E-learning
Free for CMAC and CERSI members and partners
Approx 4 hours
Register your interest:
