| 9:00 AM | - 3:00 PM | GLP-Preconference Training for Beginners
Die Teilnehmerzahl ist begrenzt!
Referent: Harston, Stephen, Honorary President, DGGF
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| |  In our German-speaking Training Session youl will learn why the GLP Principles was developed and what they will addressed.
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| 8:00 AM | | Registration
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| 9:00 AM | - 9:15 AM | Welcome 17th DGGF Annual Meeting
DGGF President Steffen König
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| 9:15 AM | - 12:00 PM | GxP Stream I
Joint Session
Chairperson: Morgenthaler, Helmuth; BASF SE, Limburgerhof, Germany
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| 9:15 AM | - 10:00 AM | Managing Contracted IT Services in GxP Environments (Contracted IT Services in GxP environments – how to deal with?)
Scheiber, Lothar; IS & S Informationstechnik GmbH, Aschaffenburg, Germany
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| 10:00 AM | - 10:45 AM |  Living in the Cloud – new GxP challenges
D’Angelo, Vincenzo; Validation Service Manager, Instem, Stone, UK
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| 10:45 AM | - 11:15 AM | Coffee Break
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| 11:15 AM | - 12:00 PM | Interactive Voice Response Systems (IVRS) – Sponsors and CRO User Acceptance Testing
Nimer, Yusef; Trial Brain, IVRS & Logistik Training, Berlin, Germany
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| 12:00 PM | - 1:30 PM | Lunch
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| 1:30 PM | - 4:00 PM | GLP / Analytic Stream
Chairperson: Henrichs, Andreas; Sanofi, Frankfurt, Germany
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| 1:30 PM | - 2:10 PM | Calibration-free concentration analysis for Immunogenicitytesting employing Biacore
Benstein, Karin; Sanofi, Frankfurt, Germany
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| 2:10 PM | - 2:50 PM | ISR and internal standard issues within a bioanalytical lab
Schmidt, Ronald; Sanofi, Frankfurt, Germany
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| 2:50 PM | - 3:20 PM | Coffee Break
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| 3:20 PM | - 4:00 PM | "Infancy problems" regarding implementation of EM(E)A "Guideline on bioanalytical method validation"
Kretzschmar, Timo; pharm-analyt Labor GmbH, Baden, Austria
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| 1:30 PM | - 5:20 PM | GLP Stream I
Chairperson: Schepers, Ulrich; BASF SE, Limburgerhof, Germany
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| 1:30 PM | - 2:10 PM | GLP In Switzerland and experiences with Mutual Joint Visits
Moor, Christoph; Eidgenössisches Departement für Umwelt, Verkehr, Energie und Kommunikation UVEK, Bundesamt für Umwelt BAFU, Worblentalstrasse 68, CH-3063 Ittigen, Schweiz
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| 2:10 PM | - 2:50 PM |  GLP Differences between FDA and EPA
Chris Clare; Covance Laboratories, Harrogate, United Kingdom
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| 2:50 PM | - 3:20 PM | Coffee Break
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| 3:20 PM | - 4:00 PM | GLP-Update
Bulling, Wolf; Bundesinstitut für Risikobewertung, Berlin, Germany
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| 4:00 PM | - 5:20 PM | Round Table Discussion – Questions and Answers
Moor, Christoph
Bulling, Wolf
Schepers, Ulrich
Moderator: Stephen Harston | |
| 1:30 PM | - 5:20 PM | GCP Stream I
Chairperson: Hartlieb, Christiane; ProTS, Monheim, Germany
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| 1:30 PM | - 2:10 PM | New regulatory requirements for clinical trials
Ruppert, Thorsten; VFA, Berlin, Germany
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| 2:10 PM | - 2:50 PM | New regulations for pharmacovigilance and the consequences
Kroth, Elmar; BAH, Bonn, Germany
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| 2:50 PM | - 3:20 PM | Coffee Break
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| 3:20 PM | - 4:00 PM | New notification obligations for AEs and their impact
Storz, Elisabeth; VFA, Berlin, Germany
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| 4:00 PM | - 4:40 PM | Audits of risk based monitoring
Minkus, Günter; Roche Pharma AG, Grenzach-Wyhlen, Germany
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| 4:40 PM | - 5:20 PM | Where is risk getting us
Wilsher, Colin; Berkhamsted, UK
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| 9:00 AM | - 12:10 PM | GLP Stream II
Chairperson: Hermann, Frauke; Harlan Cytotest Cell Research GmbH, Rossdorf, Germany
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| 9:00 AM | - 9:40 AM | Experiences of a German Federal State GLP Inspector
Jacobi, Tobias; Ministerium fuer Umwelt, Landwirtschaft, Ernaehrung, Weinbau und Forsten, Kaiser-Friedrich-Straße 1, 55116 Mainz
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| 9:40 AM | - 10:20 AM | GLP Studies in China - Challenges, Benefits and Pitfalls
Lehn, Hermann; F.Hoffmann-La Roche Ltd., Pharmaceuticals Division, 4070 Basel, Schweiz
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| 10:20 AM | - 10:50 AM | Coffee Break
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| 10:50 AM | - 11:30 AM | e-Learning
Sultan, Karim; LPT GmbH&Co.KG, Hamburg; Dobat, Sönke; DATEC pro GmbH, Hamburg
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| 11:30 AM | - 12:10 PM | GCP in a GLP bioanalytical laboratory
Henrichs;Andreas; Sanofi, Frankfurt,Germany
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| 9:00 AM | - 10:20 AM | GCP Stream II-1
Chairperson: Kammerer, Petra; Communication Services, Berlin, Germany
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| 9:00 AM | - 10:20 AM | Efficient training in a study center: - from an IEC’s perspective/- an investigator’s perspective/- a sponsor’s perspective
Helm, Jürgen; Universitätsklinikum Halle, Halle, Germany
Bergtholdt, Bettina; emovis, Berlin, Germany
Rink, Christian; Boehringer Ingelheim Pharma GmbH & Co. KG, Bremen, Germany
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| 10:20 AM | - 10:50 AM | Coffee Break
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| 9:00 AM | - 12:10 PM | GCP Stream II-2
Chairperson: Stelzer, H. Günther; CQC-hgs, Freiburg, Germany
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| 10:50 AM | - 11:30 AM | Design of contracts between sponsor and CRO with special focus on quality risk management
Steele, Jenny; Boehringer Ingelheim Ltd, Berkshire, UK
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| 11:30 AM | - 12:10 PM | Audits of clinical investigations and performance assessments with medical devices
Grund, Andreas; GCP-Services International Ltd. & Co. KG, Bremen, Germany
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| 9:00 AM | - 12:10 PM | GMP Stream
Chairperson: Schad, Christian; IS&S Informationstechnik GmbH, Aschaffenburg, Germany
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| 9:00 AM | - 9:40 AM | CAPA in small and medium enterprises
Kretzschmar, Timo; pharm-analyt Labor GmbH, Baden, Austria
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| 9:40 AM | - 10:20 AM | Implementation of an electronic deviation management
Sander, Nadine; AllessaChemie GmbH, Frankfurt, Germany
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| 10:20 AM | - 10:50 AM | Coffee Break
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| 10:50 AM | - 11:30 AM | GMP-relevant criterias for production of adhesives
Eichelmann, Holger; Henkel AG & Co. KGaA, Düsseldorf, Germany
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| 11:30 AM | - 12:10 PM | Round table discussion
Schad, Christian; IS+S Informationstechnik GmbH, Aschaffenburg, Germany
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| 12:10 PM | - 1:30 PM | Lunch
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| 1:30 PM | - 3:30 PM | GxP Stream II
Joint GxP Session:
Chairperson: Fröhlke, Erinita; Covance Laboratories GmbH, Münster, Germany
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| 1:30 PM | - 2:30 PM | About the psychology of audit situations
Kammerer, Petra; Communication Services, Berlin, Germany
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| 2:30 PM | - 3:30 PM | Risk Perception Between Mania And Reality
Bhakdi, Sucharit; Mainz; Germany
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| 3:30 PM | - 3:45 PM | Closing Remarks
DGGF President Steffen König
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| 3:45 PM | - 4:30 PM | DGGF Annual Meeting (Members)
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