Course: “Pre-Clinical and Clinical Safety in Early Development Human Trials” - by AFPT-Club Phase 1 & EUFEMED
Open for registration!
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products.
The training of several days provides a concise overview on safety in Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man to proof-of-concept clinical trials.
📅 09-13 March 2026 – 5 full days in Paris-Saclay University, France
📍UNIVERSITÉ PARIS-SACLAY, SITE HENRI MOISSAN, 17 avenue des Sciences, 91400 Saclay, France
Course exclusively in English and in presential due to its interactive nature.
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Click here for the Full Course Schedule and other important information
Learning Outcomes:
On successful completion, students should be able to demonstrate an understanding / knowledge of the following:
- Minimal nonclinical safety package to support the first dose in human (FIH) (Remember).
- Risk assessment from non-clinical safety package (Apply).
- How to read and understand an Investigator’s Brochure (IB) prior to early clinical trials (Apply).
- Contributing safety findings from early phase trial to the IB (Apply).
- Specific aspects of how-to set-up and conduct safe early phase clinical trials (Apply).
- Selection of appropriate trial population (Understand).
- Assessment, evaluation, and reporting of safety data from early clinical trials (Understand).
- Defining pharmacokinetic (PK) endpoints / exposure limit for early phase clinical trials (Apply).
- Safety biomarkers (Understand).
- Development safety update reports (Apply).
- Development of risk management plans (Apply).
- Most important medical emergencies in early clinical trials (Remember).
- Characteristic safety issues involved in the development of biologicals and advanced therapies (Understand).