Confirming Trials: Methodology and Biostatistics

Aim

The different tests and methods of biostatistics are discussed. The application of different trial designs is simulated, within-trial decisions, data management, extraction, manipulation and storage of data.

Location & Organization

Organizer

ECPM - European Center of Pharmaceutical Medicine, University of Basel

Faculty / Teachers

Enrica Alteri, Serono International S.A., Plan-les-Ouates, Abdel Babiker, MRC Clinical Trial Unit, London, Peter Bauer, Medizinische Universität Wien, Vienna, Stella Blackburn, EMEA, London, Michael Branson, Novartis Pharma AG, Basel, Hans Ulrich Burger, F. Hoffmann-La Roche AG, Basel, Suzy De Cordt, Serono, Geneva, Peter Jüni, University of Bern, Bern, Hans Kemmler, Swissmedic, Bern, Xavier Lataste, Novartis Pharma AG, Basel, Adam Lowy, Novartis Pharma AG, Basel, Robert T. O'Neill, Food and Drug Administration FDA, Rockville, Norbert Neumann, F. Hoffmann-La Roche AG, Basel, Iris Pigeot, BIPS, Bremen, Maurizio Rainisio, Actelion, Allschwil, Stots B. Reele, AstraZeneca, Macclesfield, Cheshire, Joachim Röhmel, Federal Institute for Drugs and Medical Devices, BfArM, Berlin, Matthias Schwenkglenks, ECPM, Basel, Thomas D. Szucs, ECPM, Basel, Joachim Vollmar, International Clinical Development, Solana Beach, CA, Jeff Wald, Pharsight, Mountain View, CA, Noël Wathion, EMEA, London

Location / venue

Pharmacenter, University of Basel

Costs

ECPM Course incl. six modules 11’500 CHF; for members of the University 4’000 CHF

Timing & Workload

Duration Four days
ECTS points 30 (see remarks)
 

Teaching methods used

Teaching incl. case studies

Examination yes

Criteria

Is the course taught in English? yes
Is documentation available? (book, syllabus)? yes
Is the course open for external researchers? yes

Remarks

This is a Base Module in the ECPM course for post graduates. Costs and ECTS points listed are for the total ECPM master program. The complete program consists of six four-day modules over two years.

More Information

http://www.ecpm.ch