Global Registration and Approval Process

Aim

Overview on mechanisms and regulatory management systems in Europe, the USA and Asia. Requirements of a regulatory application, documentation and collaboration between developers and regulators. Special regulatory procedures, strategies and crisis management.

Location & Organization

Organizer

ECPM - European Center of Pharmaceutical Medicine, University of Basel

Faculty / Teachers

Gunnar Alvan, Medical Products Agency, Uppsala, Richard Bergström, The Swedish Association, Stockholm, Gerd Bode, Altana Pharma, Hamburg, Hilde Boone, EMEA, London, Alasdair Breckenridge, Medicines and Healthcare products Regulatory Agency, London, Dagmar Chase, Clinrex GmbH, München, Michael Doherty, F. Hoffmann - La Roche AG, Basel, Catarina Edfjäll, Celgene, Neuchâtel, Andrew Fox, Amgen Europe, Cambridge, CB4 0WD, Dave Gilbert, Pharmacia, Buckinghamshire, Peter Herrmann, Actelion Pharmaceuticals AG, Allschwil, Masaru Iwasaki, GlaxoSmithKline K.K., Tokyo, Randy Levin, Food and Drug Administration, Rockville, Murray M. Lumpkin, Food and Drug Administration FDA, Rockville, David J. Lyons, Irish Medicines Board, Dublin, Andrew Marr, GlaxoSmithKline, Greenford, Jacques Mascaro, F. Hoffmann-La Roche AG, Basel, Per Nilsson, Actelion Pharmaceuticals Ltd., Allschwil, Kevin O'Connell, GlaxoSmithKline Pharmaceuticals, Harlow, John Purves, EMEA, London, Guy Rousseau, Novartis Pharma AG, Basel, Rashmi Shah, Consultant, London, Burkhard Sträter, Lawyer, Bonn, Olof Tydén, EUREDA, Uppsala, Michael J. Vivion, Executive Communications Group, New Jersey, Daniel Weston, Novartis Consumer Health, Nyon, Christa Wirthumer-Hoche, AGES PharmMed, Wien, Li Zeng, F. Hoffmann-La Roche AG, Basel

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