AGAH e.V. INTRODUCTORY COURSE IN EXPLORATORY MEDICINES DEVELOPMENT, Part II
AGAH e.V. Association for Applied Human Pharmacology (AGAH) e.V.
Phone: +49 (0)170 78 444 38
e-Mail: info@agah.eu
Registration & Contact
CSi Hamburg GmbH
Goernestraße 30
20249 Hamburg (Germany)
Phone: +49 (0)40 30 770 300
Telefax: +49 (0)40 30 770 301
E-Mail: agah-meetings@csihamburg.de
INTRODUCTION AND LEARNING OUTCOMES
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of 3 days each 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
Part I: 30 Novemver - 02 December 2016
