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 512074 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
Monday November 27th, 2006 11.30 Registration 12.15 Introduction Gerold Schuler, Dept. of Dermatology, Erlangen 12.30 DanDrit Biotech A/S IP Strategy Mai-Britt Zocca, DanDrit Biotech A/S, Copenhagen 13.30 Efficient Preparation of a GCP-Inspection 14.30 Coffee Break 15.00 Clinical Monitoring: How to Collect Credible and Accurate Data Andreas Brune, Schering AG, Berlin 16.00 The Coordination Centre for Clinical Trials in Berlin (KKS-Charité) Ephrat Lahmer-Naim, KKS Charité, Berlin 16.30 Implementation of a Cell Therapy Trial according to GCP in Italy Marco Bregni, Scientific Institute San Raffaele, Milan 17.00 Coffee Break 17.30 GCP Experiences from Denmark Anders Mellemgaard, University Hospital Copenhagen 18.00 What Does Go Wrong in Early Phase Clinical Trials? Audit Observations, Case Studies and Insights 19.00 End 20.00 Dinner Social Evening
Tuesday November 28th, 2006 8.00 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 10.00 Coffee Break 10.30 Methodological and Statistical Aspects regarding the Planning of Clinical Trials Christoph Meisner, Institute for Medical Information Processing, University Tuebingen 11.30 Core Documents in Clinical Trials Purpose, Contents and Points to Consider IB - Protocol - CRF - Informed Consent - Report 12.45 Lunch 14.00 How to Prepare an IMPD 15.00 Coffee Break 15.30 From Source Data to Clean Data Managing Data in Clinical Trials An Overview on GCP Requirements for Data Management and Statistics 16.30 Safety in Clinical Trials 17.15 End
Organisation Dr. Brigitte Zuleger Email: brigitte.zuleger@derma.imed.uni-erlangen.de Phone: +49 91 31 85 3 6113 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: +49 91 31 85 3 38 19 Fax: +49 91 31 85 3 37 01 Email: brigitte.woelfel@derma.imed.uni-erlangen.de Location Venue Dorint Hotel Hofmannstrasse 34 Phone: +49 91 31 9747-0 Fax: +49 91 31 9747-500 http://www.tagungshotel.com/hotel_en_1070541461.htm Hotel Reservation Fremdenverkehrsfoerderung Erlangen Rathausplatz 1 Phone: +49 91 31 8 95 10 http://www.erlangen.notblue.de/tourismus_verkehr/hotel/erlangen.htm Sponsored by Novartis Oncology
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 14 91052 Erlangen Fax: +49-9131-85-33701 Name Address Phone Fax E-Mail 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: 763 500 00 Account: 464 IBAN: DE28763500000000000464 / BIC: BYLADEM1ERH pls. note in favour of Kostenstelle 36012019 Date Signature