GOOD CLINICAL PRACTICE PROGRAM. Workshop 2006 DC THERA. November 27th 28th 2006, Dorint Hotel Erlangen, Germany

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1 DC THERA Dendritic Cells & New Immunotherapies EU Sixth Framework Programme Life Science, Genomics and Biotechnology for Health DC-THERA Dendritic Cells & New Immunotherapies Network of Excellence, Project Workshop 2006 Organized by the Therapeutic Cluster of DC-THERA, Cluster Coordinator Prof. Gerold Schuler Certified by the Bayerische Landesärztekammer with 15 CME credits GOOD CLINICAL PRACTICE November 27th 28th 2006, Dorint Hotel Erlangen, Germany PROGRAM

2 Monday November 27th, Registration Introduction Gerold Schuler, Dept. of Dermatology, Erlangen DanDrit Biotech A/S IP Strategy Mai-Britt Zocca, DanDrit Biotech A/S, Copenhagen Efficient Preparation of a GCP-Inspection Coffee Break Clinical Monitoring: How to Collect Credible and Accurate Data Andreas Brune, Schering AG, Berlin The Coordination Centre for Clinical Trials in Berlin (KKS-Charité) Ephrat Lahmer-Naim, KKS Charité, Berlin Implementation of a Cell Therapy Trial according to GCP in Italy Marco Bregni, Scientific Institute San Raffaele, Milan Coffee Break GCP Experiences from Denmark Anders Mellemgaard, University Hospital Copenhagen What Does Go Wrong in Early Phase Clinical Trials? Audit Observations, Case Studies and Insights End Dinner Social Evening

3 Tuesday November 28th, Basic Legal Requirements for the Performance of Clinical Trials in Germany and Europe Horst Hasskarl, Dr. Hasskarl & Kollegen, Ludwigshafen 9.00 Clinical Trial Application for Tumor Vaccines at the Paul-Ehrlich-Institute Thomas Hinz, Paul-Ehrlich-Institute, Langen Coffee Break Methodological and Statistical Aspects regarding the Planning of Clinical Trials Christoph Meisner, Institute for Medical Information Processing, University Tuebingen Core Documents in Clinical Trials Purpose, Contents and Points to Consider IB - Protocol - CRF - Informed Consent - Report Lunch How to Prepare an IMPD Coffee Break From Source Data to Clean Data Managing Data in Clinical Trials An Overview on GCP Requirements for Data Management and Statistics Safety in Clinical Trials End

4 Organisation Dr. Brigitte Zuleger Phone: Registration DC-THERA members + associated partners: No registration fee, hotel-costs will be covered by DC-THERA NON-DC-THERA: Early registration fee until October 1 st : 150,00 Late registration fee after October 1 st : 250,00 Registration fee includes social evening, lunch and coffee breaks Secretary / Registration Brigitte Woelfel Hautklinik Erlangen Hartmannstrasse 14 Phone: Fax: brigitte.woelfel@derma.imed.uni-erlangen.de Location Venue Dorint Hotel Hofmannstrasse 34 Phone: Fax: Hotel Reservation Fremdenverkehrsfoerderung Erlangen Rathausplatz 1 Phone: Sponsored by Novartis Oncology

5 DC THERA Dendritic Cells & New Immunotherapies Registration Form GOOD CLINICAL PRACTICE WORKSHOP 2006 Please send this form via fax to the workshop secretariat Mrs. Brigitte Wölfel c/o Hautklinik Erlangen Hartmannstraße Erlangen Fax: Name Address Phone Fax Registration fee: Early registration fee until October 1 st : 150,00 Late registration fee after October 1 st : 250,00 No registration fee for DC-THERA members and associated partners Please remit the total balance to: Sparkasse Erlangen Bank code: Account: 464 IBAN: DE / BIC: BYLADEM1ERH pls. note in favour of Kostenstelle Date Signature