Introductory course in exploratory medicines development, Part I Back
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products.
Two training parts of 3 days each (Parts I and II) 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.
Part I provides an introduction into early / exploratory trials in healthy subjects and patients with a special focus on regulatory and ethical prerequisites, trial preparation and conduct as well as essential documents required. Attendees learn how to define appropriate eliligibity criteria for an early phase trial population. Moreover, specific aspects of experimental formulations of trial medication are discussed. Attendees are introduced to basic principles of pharmacokinetics.
On successful completion of Part I, students should be able to demonstrate an understanding / knowledge of the following aspects:
- 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
- Design and planning of an early phase clinical trial
- Basics of pharmacokinetics defining pharmacokinetic (PK) endpoints for early phase clinical trials