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Introductory course in exploratory medicines development, Part I    Back

Association for Applied Human Pharmacology AGAH e.V. in Germany Course Type: Short courses (CPD) Start Date: To be announced
Duration: Full time - 3 Days Fees/total cost: To be announced

Description

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.

Learning Outcomes

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

Course contact information

AGAH office
Course Administrator
AGAH e.V.
info@agah.eu
This course meets 9 out of 9 IMI Education & Training shared quality standards ( Show Details)
  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered
Last update: 01/09/2016
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