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Introductory Course in Exploratory Medicines Development – Part II ONLINE COURSE

17. September 2020 - 22. September 2020

Language: English

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:

  • 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 development plan
  • Planning and management of a first-in-man trial with single and multiple ascending dose parts
  • Principles of data management and information flow
  • Principles of reporting and publication
  • Principles of biometrics and 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).


Working platform = Microsoft Teams

REGISTRATION & Attendance fee

Registration closed

free places on request: agah-meetings[@]csihamburg.de

CONTACT and further information

CSi Hamburg GmbH
Goernestraße 30
20249 Hamburg (Germany)

phone: +49 40 30770300

17. September 2020 - 22. September 2020

Introductory Course in Exploratory Medicines Development – Part II ONLINE COURSE