Introductory Course in Exploratory Medicines Development – Part II ONLINE KURS

This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of several days provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials.

Learning Outcomes

On successful completion of Part 1, students should be able to demonstrate an understanding / knowledge of the following:

• Nonclinical pharmacology and toxicology
• Molecular basis of drug actions
• Allometric scaling and dose proportionality assessments based on characteristic PK data
• Defining pharmacodynamic (PD) endpoints and biomarkers
• Differentiating between primary and secondary PK and PD endpoints
• How to design an early clinical pharmacology development plan
• Planning and management of a first-in-man trial with single and multiple ascending dose parts
• Principles of data management and information flow
• Principles of reporting and publication
• Principles of biometrics and medical statistics
• Characteristic issues involved in the development of biologicals and biosimilars

This AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The previous courses  were accredited 3 ECTS (Parts I plus II).