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Introductory Course in Exploratory Medicines Development – Part II

31. März 2020 - 3. April 2020
Oberursel (Germany),
INTRODUCTION and Learning Outcomes

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).

REGISTRATION & Attendance fee

Download registration form: AGAH_ICiEM_Registration_form

CONTACT and further information

CSi Hamburg GmbH
Goernestraße 30
20249 Hamburg (Germany)

phone: +49 40 30770300

31. März 2020 - 3. April 2020

Introductory Course in Exploratory Medicines Development – Part II

Oberursel (Germany)