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16th DGGF International Meeting
Tagungen/Jahrestagung 2011
Die 16. Jahrestagung 2011 fand vom 22. bis 23. September 2011 im Maritim Hotel in Berlin statt.
URL: http://www.dggf.de/de/tagungen/tagung.aspx?tagung=3
Deutsche Gesellschaft für Gute Forschungspraxis e.V.
Seite 1 von 12
Programm
Donnerstag, 22. September 2011
08:00
09:00
Registration
- 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
eRecords – Sustainable Data Formats for Long Term Archiving
and Retrieval (DE)
(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
Seite 2 von 12
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
Impact of the 4th Update of the Medical Device Law and the
MPKPV on the Ethics Commissions
(DE)
Dewitz, Christian von - Ethik-Kommission des Landes Berlin, Berlin, Germany
14:10
- 14:50
Clinical Investigations with Medical Devices: The New Role of
the Competent Authority
(DE)
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
Techniques to Investigate Immunogenicity with Specific
Attention to BIACORE Based Strategy
(DE)
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 2011
09:00
- 12:10
GLP Stream II
Chairperson: Frauke Hermann, Harlan Cytotest Cell Research GmbH,
Rossdorf, Germany
Seite 3 von 12
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
ToGCPornottoGCP–AFeasibleWayto Implement QM in
Academic Institutions
(DE)
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
A Coordinated Surveillance Approach – The New Concept for
GCP Inspections
(DE)
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
Implementation of a Combined GLP- and GMP-Quality
Management System in a Non-Clinical Contract Research
Organization (Purpose – Limitations – Effort – Synergies)
(DE)
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
Seite 4 von 12
Programm
10:50
- 11:30
GMP-Related Criteria in the Manufacture of Printing Inks for
Food and Pharmaceutical Packaging
(DE)
Seyer, Hans-Peter Flint Group Germany GmbH, Stuttgart, Germany
11:30
- 12:10
Risk-Based Validation in Pharmaceutical Research and
Development
(EN)
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
Re-Establishment of Business in a Test Facility after a Fire
Damage
(DE)
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)
Seite 5 von 12
Vorträge
(DE)
A Coordinated Surveillance Approach – The New Concept for GCP Inspections
Freitag, 23. September 2011, 11:30 - 12:10
(US)
Donnerstag, 22. September 2011, 14:10 - 14:50
(DE)
Belgian MA Experiences with Inspections in Non-Member Adherent Countries to the OECD GLP
MAD System
(EN)
(DE)
Clinical Investigations with Medical Devices: The New Role of the Competent Authority
(DE)
(DE)
(DE)
(DE)
eRecords – Sustainable Data Formats for Long Term Archiving and Retrieval (DE)
(DE)
(DE)
(US)
Viswanathan, CT.
(DE)
GLP Update - OECD
Seite 6 von 12
Vorträge
GMP-Related Criteria in the Manufacture of Printing Inks for Food and Pharmaceutical
Packaging
(DE)
(DE)
GxP-Updates
(DE)
(DE)
Impact of the 4th Update of the Medical Device Law and the MPKPV on the Ethics Commissions
Implementation of a Combined GLP- and GMP-Quality Management System in a Non-Clinical
Contract Research Organization (Purpose – Limitations – Effort – Synergies)
(DE)
(DE)
(DE)
Inspection Experience and Interpretation of EMA / FDA Guidance on e-Source Data and e-CRF
(DE)
(DE)
Re-Establishment of Business in a Test Facility after a Fire Damage
Regulatory Aspects of Clinical Studies with Combinations Products According to German Drug
Law and Medical Device Law
(DE)
(DE)
Seite 7 von 12
Vorträge
(EN)
Risk-Based Validation in Pharmaceutical Research and Development
(DE) (EN) (US)
Jacobs, Guido
Viswanathan, CT.
Bulling, Wolf
Schepers, Ulrich
(DE)
Techniques to Investigate Immunogenicity with Specific Attention to BIACORE Based Strategy
(DE)
(DE)
ToGCPornottoGCP–AFeasibleWayto Implement QM in Academic Institutions
(US)
(EN)
Seite 8 von 12
Referenten
Techniques to Investigate Immunogenicity with Specific Attention to BIACORE Based Strategy
Bulling, Wolf
GLP Update - OECD
Impact of the 4th Update of the Medical Device Law and the MPKPV on the Ethics Commissions
Inspection Experience and Interpretation of EMA / FDA Guidance on e-Source Data and e-CRF
A Coordinated Surveillance Approach – The New Concept for GCP Inspections
Jacobs, Guido
Seite 9 von 12
Referenten
Belgian MA Experiences with Inspections in Non-Member Adherent Countries to the OECD GLP MAD System
Risk-Based Validation in Pharmaceutical Research and Development
ToGCPornottoGCP–AFeasibleWayto Implement QM in Academic Institutions
Clinical Investigations with Medical Devices: The New Role of the Competent Authority
GxP-Updates
Seite 10 von 12
Referenten
Schepers, Ulrich
GxP-Updates
eRecords – Sustainable Data Formats for Long Term Archiving and Retrieval (DE)
GMP-Related Criteria in the Manufacture of Printing Inks for Food and Pharmaceutical Packaging
GxP-Updates
Regulatory Aspects of Clinical Studies with Combinations Products According to German Drug Law and Medical Device Law
Viswanathan, CT.
Seite 11 von 12
Referenten
Implementation of a Combined GLP- and GMP-Quality Management System in a Non-Clinical Contract Research Organization
(Purpose – Limitations – Effort – Synergies)
Seite 12 von 12

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