Wann:
13. Februar 2014 – 15. Februar 2014 ganztägig
2014-02-13T00:00:00+01:00
2014-02-16T00:00:00+01:00
Wo:
SRH Business Academy GmbH
Bonhoefferstraße 12
69123 Heidelberg
Deutschland
Preis:
1000,00
Kontakt:
CSi Hamburg GmbH
+49 40 307720 97

Medicine – Part II

The continuation of the November 2013 workshop; new participants are welcome.

More Information, Program and Registration: http://www.agah.eu/veranstaltungen

Introduction and Learning Outcomes

This course provides a basic training in Human Pharmacology and is addressed to postgraduates in life sciences interested in early clinical development of medicinal products.

Learning Outcomes

On successful completion of Part 2 of this course, students should be able to demonstrate an understanding / knowledge of the following:

  • integration of pertinent available scientific information into an IB and a clinical trial protocol
  • specific aspects of how to set-up and conduct early phase clinical trials
  • defining endpoints for early phase clinical trials
  • differentiating between primary and secondary endpoints
  • assessment and evaluation of safety data from clinical trials
  • GCP / GLP method validation
  • proof of mechanism and proof of concept
  • principles of medical statistics
  • principles of data management and information flow
  • molecular basis of drug action
  • development of biologicals and biosimilars

 

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