Introductory Course in Exploratory Medicines Development – Part II

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 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 2, 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 developmant plan
• planning and management of a first-in-man trial
• principles of data management and information flow
• principles of reporting and publication
• principles of 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).