Module 5 Presentations

16/07/2024

Progression of clinical trials in relation to the toxicology programme

Simon Craige, MSc, ERT, DABT, DipRCPath(Tox) EdGe Toxicology Consulting Limited

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Introduction – Learning Outcomes

• What are the clinical trial stages? • Non-clinical safety assessment • Primarily “small molecules” • Secondarily at biopharmaceuticals (case by case) • The guidelines now

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

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