16th DGGF International Meeting
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- Elijah Pearson
- 7 years ago
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1 Die 16. Jahrestagung 2011 fand vom 22. bis 23. September 2011 im Maritim Hotel in Berlin statt. Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 1 von 12
2 Programm Donnerstag, 22. September :00 Registration 09:00-09:10 Welcome 16th Annual Meeting DGGF President Steffen Konig 09:10-12:00 GxP Stream I Joint Information Technology Session Chairperson: Helmuth Morgenthaler, BASF SE, Limburgerhof, Germany 09:10-09:30 (DE) GxP-Updates Stelzer, Gunther; CQC-hgs, Freiburg, Germany Schepers, Ulrich; BASF SE, Limburgerhof, Germany Schad, Christian; IS&S Informationstechnik GmbH, Aschaffenburg, Germay 09:30-10:10 (DE) erecords Sustainable Data Formats for Long Term Archiving and Retrieval (DE) Schifferdecker, Georg Hewlett-Packard GmbH, Bad Homburg, Germany 10:10-10:50 (DE) Electronic SOP-Management Benefits and Challenges Hickstein, Thomas Bayer CropScience AG, Frankfurt, German 10:50-11:20 Coffee Break 11:20-12:00 (US) Validation Innovations Regehr, Michael F. BASF Corporation, Research Triangle Park, NC, USA 12:00-13:30 Lunch 13:30-17:20 GLP Stream I Chairperson: Ulrich Schepers, BASF SE, Limburgerhof, Germany 13:30-14:10 (US) GLP Modernization What Does This Mean to You... Viswanathan, CT. FDA, Silver Spring MD, USA 14:10-14:50 (US) Audit Findings The Other Side of Failure Viswanathan, CT. FDA, Silver Spring MD, USA 14:50-15:20 Coffee Break 15:20-16:00 (DE) Inspection Results from German Test Facilities Gottschalk, Marina Bundesinstitut fur Risikobewertung, Berlin, Germany Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 2 von 12
3 Programm 16:00-17:20 (DE) (EN) (US) Round Table Discussion Questions and Answers Jacobs, Guido Viswanathan, CT. Bulling, Wolf Schepers, Ulrich Moderator: Stephen Harston 13:30-17:20 GCP Stream I Chairperson: Andreas Grund, GCP-Service International, Bremen, Germany Chairperson: H. Gunther Stelzer, CQC-hgs, Freiburg, German 13:30-14:10 (DE) Impact of the 4th Update of the Medical Device Law and the MPKPV on the Ethics Commissions Dewitz, Christian von - Ethik-Kommission des Landes Berlin, Berlin, Germany 14:10-14:50 (DE) Clinical Investigations with Medical Devices: The New Role of the Competent Authority Reiners, Ana-Lena BfArM, Bonn, Germany 14:50-15:20 Coffee Break 15:20-16:00 (DE) Regulatory Aspects of Clinical Studies with Combinations Products According to German Drug Law and Medical Device Law Thevarajah, Judith GCP-Service International Ltd. & Co. KG, Bremen, Germany 16:00-16:40 (DE) ICH Guideline E2F Development Safety Update Reports Becker, Susanne spm2 safety projects & more GmbH, Mannheim, Germany 16:40-17:20 (DE) The Future Dimension of Monitoring Henn, Doris Katharina AstraZeneca GmbH, Wedel, Germany 13:30-16:00 GLP / Analytic Stream Chairperson: Andreas Henrichs Sanofi, Frankfurt, Germany 13:30-14:10 (DE) Techniques to Investigate Immunogenicity with Specific Attention to BIACORE Based Strategy Benstein, Karin Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany 14:10-14:50 (DE) Experience with Dried Blood Spot Technique at Sanofi-Aventis Schmidt, Ronald Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany 14:50-15:20 Coffee Break 15:20-16:00 (DE) FDA Claim 0 Re-Integration Concerning Chromatograms Kretzschmar, Timo Pharm-Analyt Labor GmbH, Baden, Austria Freitag, 23. September :00-12:10 GLP Stream II Chairperson: Frauke Hermann, Harlan Cytotest Cell Research GmbH, Rossdorf, Germany Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 3 von 12
4 Programm 09:00-09:40 (DE) GLP Update - OECD Bulling, Wolf Bundesinstitut fur Risikobewertung, Berlin, Germany 09:40-10:20 (DE) Impressions from a GLP Field Trial Workshop in China Kellner, Olaf BASF SE, Limburgerhof, Germany 10:20-10:50 Coffee Break 10:50-11:30 (EN) Belgian MA Experiences with Inspections in Non-Member Adherent Countries to the OECD GLP MAD System Jacobs, Guido Scientific Institute of Public Health, Brussels, Belgium 11:30-12:10 (EN) What Does it Take to do GLP Studies at a CRO in China? Mutch, Marian Covance Pharmaceutical Co. Ltd, Shanghai, China 09:00-12:10 GCP Stream II Chairperson: Christiane Hartlieb-Wallthor- Sano, ProTS, Monheim, Germany Chairperson: Kerstin Konig, ImClone Systems International GmbH, Heidelberg, Germany 09:00-09:40 (DE) Revision of the German and European Regulations Ruppert, Thorsten VFA, Berlin, Germany 09:40-10:20 (DE) ToGCPornottoGCP AFeasibleWayto Implement QM in Academic Institutions Lustenberger, Jurg University Hospital Zurich, Zurich, Switzerland 10:20-10:50 Coffee Break 10:50-11:30 (DE) Inspection Experience and Interpretation of EMA / FDA Guidance on e-source Data and e-crf Gertzen, Heiner Sanofi, Paris, France 11:30-12:10 (DE) A Coordinated Surveillance Approach The New Concept for GCP Inspections Huber, Susanne Regierungsprasidium Hessen, Darmstadt, Germany 09:00-12:10 GMP Stream Chairperson: Christian Schad, IS&S Informationstechnik GmbH, Aschaffenburg, Germany 09:00-09:40 (DE) Implementation of a Combined GLP- and GMP-Quality Management System in a Non-Clinical Contract Research Organization (Purpose Limitations Effort Synergies) Wollbold, Frithjof vivo Science GmbH, Gronau, Germany 09:40-10:20 (DE) Audit Findings at the Interfaces of GLP/GMP Wieser, Verena Baxter AG, Wien, Austria 10:20-10:50 Coffee Break Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 4 von 12
5 Programm 10:50-11:30 (DE) GMP-Related Criteria in the Manufacture of Printing Inks for Food and Pharmaceutical Packaging Seyer, Hans-Peter Flint Group Germany GmbH, Stuttgart, Germany 11:30-12:10 (EN) Risk-Based Validation in Pharmaceutical Research and Development Kennedy, Ian Covance Inc., Alnwick, UK 12:10-13:30 Lunch 13:30-15:30 GxP Stream II Joint GxP Session: Chairperson: Holger Dittberner, Nycomed GmbH, Barsbuttel, German 13:30-14:00 (DE) Educational Deficiencies in QA Knowledge Pomp, Jurgen Hochschule Bonn-Rhein-Sieg, Rheinbach, Germany 14:00-15:00 (DE) Communication and Audit how to Deal with Trouble Zimmermann, Peter C. iskom, Neuss, Germany 15:00-15:30 (DE) Re-Establishment of Business in a Test Facility after a Fire Damage Roth, Andreas Isomehr GmbH, Saarbrucken, Germany Thirase, Katharina Siemens AG, Frankfurt am Main, Germay 15:30-15:40 Closing Remarks DGGF President Steffen Konig 15:40-16:30 DGGF Annual Meeting (Members) Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 5 von 12
6 Vorträge (DE) A Coordinated Surveillance Approach The New Concept for GCP Inspections Huber, Susanne Regierungsprasidium Hessen, Darmstadt, Germany Freitag, 23. September 2011, 11:30-12:10 (US) Audit Findings The Other Side of Failure Viswanathan, CT. FDA, Silver Spring MD, USA Donnerstag, 22. September 2011, 14:10-14:50 (DE) Audit Findings at the Interfaces of GLP/GMP Wieser, Verena Baxter AG, Wien, Austria Freitag, 23. September 2011, 09:40-10:20 (EN) Belgian MA Experiences with Inspections in Non-Member Adherent Countries to the OECD GLP MAD System Jacobs, Guido Scientific Institute of Public Health, Brussels, Belgium Freitag, 23. September 2011, 10:50-11:30 (DE) Clinical Investigations with Medical Devices: The New Role of the Competent Authority Reiners, Ana-Lena BfArM, Bonn, Germany Donnerstag, 22. September 2011, 14:10-14:50 (DE) Communication and Audit how to Deal with Trouble Zimmermann, Peter C. iskom, Neuss, Germany Freitag, 23. September 2011, 14:00-15:00 (DE) Educational Deficiencies in QA Knowledge Pomp, Jurgen Hochschule Bonn-Rhein-Sieg, Rheinbach, Germany Freitag, 23. September 2011, 13:30-14:00 (DE) Electronic SOP-Management Benefits and Challenges Hickstein, Thomas Bayer CropScience AG, Frankfurt, German Donnerstag, 22. September 2011, 10:10-10:50 (DE) erecords Sustainable Data Formats for Long Term Archiving and Retrieval (DE) Schifferdecker, Georg Hewlett-Packard GmbH, Bad Homburg, Germany Donnerstag, 22. September 2011, 09:30-10:10 (DE) Experience with Dried Blood Spot Technique at Sanofi-Aventis Schmidt, Ronald Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany Donnerstag, 22. September 2011, 14:10-14:50 (DE) FDA Claim 0 Re-Integration Concerning Chromatograms Kretzschmar, Timo Pharm-Analyt Labor GmbH, Baden, Austria Donnerstag, 22. September 2011, 15:20-16:00 (US) GLP Modernization What Does This Mean to You... Viswanathan, CT. FDA, Silver Spring MD, USA (DE) GLP Update - OECD Bulling, Wolf Bundesinstitut fur Risikobewertung, Berlin, Germany Freitag, 23. September 2011, 09:00-09:40 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 6 von 12
7 Vorträge (DE) GMP-Related Criteria in the Manufacture of Printing Inks for Food and Pharmaceutical Packaging Seyer, Hans-Peter Flint Group Germany GmbH, Stuttgart, Germany Freitag, 23. September 2011, 10:50-11:30 (DE) GxP-Updates Stelzer, Gunther; CQC-hgs, Freiburg, Germany Schepers, Ulrich; BASF SE, Limburgerhof, Germany Schad, Christian; IS&S Informationstechnik GmbH, Aschaffenburg, Germay Donnerstag, 22. September 2011, 09:10-09:30 (DE) ICH Guideline E2F Development Safety Update Reports Becker, Susanne spm2 safety projects & more GmbH, Mannheim, Germany Donnerstag, 22. September 2011, 16:00-16:40 (DE) Impact of the 4th Update of the Medical Device Law and the MPKPV on the Ethics Commissions Dewitz, Christian von - Ethik-Kommission des Landes Berlin, Berlin, Germany (DE) Implementation of a Combined GLP- and GMP-Quality Management System in a Non-Clinical Contract Research Organization (Purpose Limitations Effort Synergies) Wollbold, Frithjof vivo Science GmbH, Gronau, Germany Freitag, 23. September 2011, 09:00-09:40 (DE) Impressions from a GLP Field Trial Workshop in China Kellner, Olaf BASF SE, Limburgerhof, Germany Freitag, 23. September 2011, 09:40-10:20 (DE) Inspection Experience and Interpretation of EMA / FDA Guidance on e-source Data and e-crf Gertzen, Heiner Sanofi, Paris, France Freitag, 23. September 2011, 10:50-11:30 (DE) Inspection Results from German Test Facilities Gottschalk, Marina Bundesinstitut fur Risikobewertung, Berlin, Germany Donnerstag, 22. September 2011, 15:20-16:00 (DE) Re-Establishment of Business in a Test Facility after a Fire Damage Roth, Andreas Isomehr GmbH, Saarbrucken, Germany Thirase, Katharina Siemens AG, Frankfurt am Main, Germay Freitag, 23. September 2011, 15:00-15:30 (DE) Regulatory Aspects of Clinical Studies with Combinations Products According to German Drug Law and Medical Device Law Thevarajah, Judith GCP-Service International Ltd. & Co. KG, Bremen, Germany Donnerstag, 22. September 2011, 15:20-16:00 (DE) Revision of the German and European Regulations Ruppert, Thorsten VFA, Berlin, Germany Freitag, 23. September 2011, 09:00-09:40 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 7 von 12
8 Vorträge (EN) Risk-Based Validation in Pharmaceutical Research and Development Kennedy, Ian Covance Inc., Alnwick, UK Freitag, 23. September 2011, 11:30-12:10 (DE) (EN) (US) Round Table Discussion Questions and Answers Jacobs, Guido Viswanathan, CT. Bulling, Wolf Schepers, Ulrich Donnerstag, 22. September 2011, 16:00-17:20 (DE) Techniques to Investigate Immunogenicity with Specific Attention to BIACORE Based Strategy Benstein, Karin Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany (DE) The Future Dimension of Monitoring Henn, Doris Katharina AstraZeneca GmbH, Wedel, Germany Donnerstag, 22. September 2011, 16:40-17:20 (DE) ToGCPornottoGCP AFeasibleWayto Implement QM in Academic Institutions Lustenberger, Jurg University Hospital Zurich, Zurich, Switzerland Freitag, 23. September 2011, 09:40-10:20 (US) Validation Innovations Regehr, Michael F. BASF Corporation, Research Triangle Park, NC, USA Donnerstag, 22. September 2011, 11:20-12:00 (EN) What Does it Take to do GLP Studies at a CRO in China? Mutch, Marian Covance Pharmaceutical Co. Ltd, Shanghai, China Freitag, 23. September 2011, 11:30-12:10 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 8 von 12
9 Referenten Becker, Susanne spm2 safety projects & more GmbH, Mannheim, Germany ICH Guideline E2F Development Safety Update Reports Donnerstag, 22. September 2011, 16:00-16:40 Benstein, Karin Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany Techniques to Investigate Immunogenicity with Specific Attention to BIACORE Based Strategy Bulling, Wolf Round Table Discussion Questions and Answers Donnerstag, 22. September 2011, 16:00-17:20 Bulling, Wolf Bundesinstitut fur Risikobewertung, Berlin, Germany GLP Update - OECD Freitag, 23. September 2011, 09:00-09:40 Dewitz, Christian von - Ethik-Kommission des Landes Berlin, Berlin, Germany Impact of the 4th Update of the Medical Device Law and the MPKPV on the Ethics Commissions FDA, Silver Spring MD, USA GLP Modernization What Does This Mean to You... Gertzen, Heiner Sanofi, Paris, France Inspection Experience and Interpretation of EMA / FDA Guidance on e-source Data and e-crf Freitag, 23. September 2011, 10:50-11:30 Gottschalk, Marina Bundesinstitut fur Risikobewertung, Berlin, Germany Inspection Results from German Test Facilities Donnerstag, 22. September 2011, 15:20-16:00 Henn, Doris Katharina AstraZeneca GmbH, Wedel, Germany The Future Dimension of Monitoring Donnerstag, 22. September 2011, 16:40-17:20 Hickstein, Thomas Bayer CropScience AG, Frankfurt, German Electronic SOP-Management Benefits and Challenges Donnerstag, 22. September 2011, 10:10-10:50 Huber, Susanne Regierungsprasidium Hessen, Darmstadt, Germany A Coordinated Surveillance Approach The New Concept for GCP Inspections Freitag, 23. September 2011, 11:30-12:10 Jacobs, Guido Round Table Discussion Questions and Answers Donnerstag, 22. September 2011, 16:00-17:20 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 9 von 12
10 Referenten Jacobs, Guido Scientific Institute of Public Health, Brussels, Belgium Belgian MA Experiences with Inspections in Non-Member Adherent Countries to the OECD GLP MAD System Freitag, 23. September 2011, 10:50-11:30 Kellner, Olaf BASF SE, Limburgerhof, Germany Impressions from a GLP Field Trial Workshop in China Freitag, 23. September 2011, 09:40-10:20 Kennedy, Ian Covance Inc., Alnwick, UK Risk-Based Validation in Pharmaceutical Research and Development Freitag, 23. September 2011, 11:30-12:10 Kretzschmar, Timo Pharm-Analyt Labor GmbH, Baden, Austria FDA Claim 0 Re-Integration Concerning Chromatograms Donnerstag, 22. September 2011, 15:20-16:00 Lustenberger, Jurg University Hospital Zurich, Zurich, Switzerland ToGCPornottoGCP AFeasibleWayto Implement QM in Academic Institutions Freitag, 23. September 2011, 09:40-10:20 Mutch, Marian Covance Pharmaceutical Co. Ltd, Shanghai, China What Does it Take to do GLP Studies at a CRO in China? Freitag, 23. September 2011, 11:30-12:10 Pomp, Jurgen Hochschule Bonn-Rhein-Sieg, Rheinbach, Germany Educational Deficiencies in QA Knowledge Freitag, 23. September 2011, 13:30-14:00 Regehr, Michael F. BASF Corporation, Research Triangle Park, NC, USA Validation Innovations Donnerstag, 22. September 2011, 11:20-12:00 Reiners, Ana-Lena BfArM, Bonn, Germany Clinical Investigations with Medical Devices: The New Role of the Competent Authority Donnerstag, 22. September 2011, 14:10-14:50 Roth, Andreas Isomehr GmbH, Saarbrucken, Germany Re-Establishment of Business in a Test Facility after a Fire Damage Freitag, 23. September 2011, 15:00-15:30 Ruppert, Thorsten VFA, Berlin, Germany Revision of the German and European Regulations Freitag, 23. September 2011, 09:00-09:40 Schad, Christian; IS&S Informationstechnik GmbH, Aschaffenburg, Germay GxP-Updates Donnerstag, 22. September 2011, 09:10-09:30 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 10 von 12
11 Referenten Schepers, Ulrich Round Table Discussion Questions and Answers Donnerstag, 22. September 2011, 16:00-17:20 Schepers, Ulrich; BASF SE, Limburgerhof, Germany GxP-Updates Donnerstag, 22. September 2011, 09:10-09:30 Schifferdecker, Georg Hewlett-Packard GmbH, Bad Homburg, Germany erecords Sustainable Data Formats for Long Term Archiving and Retrieval (DE) Donnerstag, 22. September 2011, 09:30-10:10 Schmidt, Ronald Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany Experience with Dried Blood Spot Technique at Sanofi-Aventis Donnerstag, 22. September 2011, 14:10-14:50 Seyer, Hans-Peter Flint Group Germany GmbH, Stuttgart, Germany GMP-Related Criteria in the Manufacture of Printing Inks for Food and Pharmaceutical Packaging Freitag, 23. September 2011, 10:50-11:30 Stelzer, Gunther; CQC-hgs, Freiburg, Germany GxP-Updates Donnerstag, 22. September 2011, 09:10-09:30 Thevarajah, Judith GCP-Service International Ltd. & Co. KG, Bremen, Germany Regulatory Aspects of Clinical Studies with Combinations Products According to German Drug Law and Medical Device Law Donnerstag, 22. September 2011, 15:20-16:00 Thirase, Katharina Siemens AG, Frankfurt am Main, Germay Re-Establishment of Business in a Test Facility after a Fire Damage Freitag, 23. September 2011, 15:00-15:30 Viswanathan, CT. GLP Modernization What Does This Mean to You... Round Table Discussion Questions and Answers Donnerstag, 22. September 2011, 16:00-17:20 Viswanathan, CT. FDA, Silver Spring MD, USA Audit Findings The Other Side of Failure Donnerstag, 22. September 2011, 14:10-14:50 Wieser, Verena Baxter AG, Wien, Austria Audit Findings at the Interfaces of GLP/GMP Freitag, 23. September 2011, 09:40-10:20 Wollbold, Frithjof vivo Science GmbH, Gronau, Germany Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 11 von 12
12 Referenten Implementation of a Combined GLP- and GMP-Quality Management System in a Non-Clinical Contract Research Organization (Purpose Limitations Effort Synergies) Freitag, 23. September 2011, 09:00-09:40 Zimmermann, Peter C. iskom, Neuss, Germany Communication and Audit how to Deal with Trouble Freitag, 23. September 2011, 14:00-15:00 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 12 von 12
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