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:

• principal steps in drug development - from compound selection to marketing application and beyond
• pertinent issues involved in the undertaking of early clinical research
• specific aspects of how to set-up and conduct early phase clinical trials
• regulation of medicines in Europe
• development and review of compound-specific information to ensure adherence to scientific, medical, ethical, and legal provisions
• integration of pertinent available scientific information into an IB and a clinical trial protocol
• principles of trial design, protocol submission and clinical conduct
• selection of appropriate trial population
• most common early phase clinical trials and their specific requirements
• assessment and evaluation of safety data from clinical trials
• relevance of formulation properties and in vitro characteristics of the trial medication for design and planning of an early phase clinical trial
• basics of pharmacokinetics
• defining pharmacokinetic (PK) endpoints for early phase clinical trials
• method validation according to good clinical (GCP) and good laboratory (GLP) practise practical aspects of bioequivalence trials

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).

Download: AGAH_ICiEM2020_PartII

Download registration form: AGAH_ICiEM_Registration_form