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TOPIC: Comparative effectiveness Research Thursday, 8 October 2009 GREETINGS / OPENING 10:45 AM - 12:00 AM Opening speech: Herbert Maier-Lenz, KKS Network Christoph Peters, Dean of the Medical Faculty of the University of Freiburg 10 year anniversary of the Coordinating Centres for Clinical Trials - Highlights from the KKS Network Introduction speech: Peter Lange, BMBF, Berlin REGULATORY FRAMEWORK AND HEALTH RESEARCH Plenary Session I: 12:00 AM — 1:45 PM Chairs: Herbert Maier-Lenz, Freiburg / Richard Dodel, Marburg Developments at the national level Kenan Maric, Bonn Forward Looks — Investigator-driven clinical trials in Europe Stephane Berghmans, Strasbourg Health research at the European level Manuel Hallen, Brussels Specifics for conducting clinical trials in Switzerland Claudia Weiss, Basel Lunch Buffet 1:45 PM - 2:30 PM IMPLEMENTING CLINICAL TRIALS Plenary Session II: 2:30 PM - 6:30 PM Parallel Sessions 1, 2, 3: 2:30 PM - 4:15 PM Session 1 Hospitals as contractual partners Chairs: Claus Burgardt, Bonn Markus Jones, Heidelberg Delineation of responsibilities in contracts from an industry viewpoint Torsten Ruppert, Berlin Risk distribution and liability clauses in clinical trials Alexander May, Cologne Session 2 Requirements for specific trial categories Chairs: Markus Löffler Leipzig / Martina de Zwaan, Erlangen Clinical Trials with medicinal products Alexa Hanschmann, Berlin Trials which include psychotherapeutic interventions Stefan Klingberg, Tübingen Translational research Markus Löffler, Leipzig Session 3 Data management Chairs: Michael Wittenberg, Marburg / Erika Graf, Freiburg GCP-conform data management Ingrun Leyendecker, Cologne Requirements for future-proof data management using ECRIN data centre certification/accreditation as an example Christian Ohmann, Düsseldorf MeDRA auto coding Maik Hahmann, Marburg Coffee break 16:15 pm - 16:45 pm Parallel Sessions 4, 5, 6: 4:45 PM - 6:30 PM Session 4 Central and peripheral structures within hospitals Chairs: Oliver Cornely, Cologne / Dirk Leopold, Leipzig Site management exemplified on the Leipzig Organisation Model Dirk Leopold, Leipzig From study acquisition to patient inclusion Oliver Cornely, Cologne Clinical study centres of the University hospital of Mainz Monika Seibert-Grafe, Mainz Deployment of hospital information systems Helmut Schneider, Essen Session 5 Specific trial designs / specific population groups Chairs: Walter Lehmacher, Cologne / Rudolf Korinthenberg, Freiburg Innovative trial designs Meinhard Kieser, Heidelberg The significance of 'omics' in diagnostics Michael Lalk, Greifswald Trials on rare diseases Janbernd Kirschner, Freiburg Session 6 Quality management / Auditing / Inspection Chairs: Rita Hattemer-Apostel, Zurich / Ursula Paulus , Cologne Status of the ADAMON Project Oana Brosteanu, Leipzig Audits as quality assurance instrument Christine Georgias, Cologne National and international inspections Gabriele Schwarz, Bonn COLLECTIVE DINNER - 7:30 PM: Dinner speech: Ernst Theodor Rietschel, President of the Leibniz Association Friday, 9 October 2009 COMPARATIVE EFFECTIVENESS RESEARCH Plenary Session III: 9:15 AM — 16:00 PM Chairs: Torsten Strohmeyer, Munich / Wolf-Dieter Ludwig, Berlin Meaning of Head-to-Head clinical trials for CER Walter Lehmacher, Cologne Reconcilability of knowledge attainment and care proximity Wilhelm Niebling, Freiburg Bridging evidence gaps Stefan Lange, Cologne Lunch buffet 12:30 PM — 1:30 PM Experiences from mega-trials Magnus Baumhäkel, Homburg Financing real life effectiveness research / aspects relating to economic efficiency Volker Jacobs, Munich Round table discussion: 3:00 PM - 4:00 PM Conclusion / Consensus Flyer_German, PDF |
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