21. Jahrestagung der DGGF

Transkript

1 Die 21. Jahrestagung 2016 findet vom 22. bis 23. September 2016 im Maritim Hotel, Bonn statt. Sollten Sie Fragen haben oder weitere Informationen benötigen, stehen wir Ihnen unter der Adresse gerne zur Verfügung. Ab sofort können Sie Vorträge mit dem Formular call for abstracts an senden.... Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 1 von 11

2 Programm Mittwoch, 21. September :00-17:30 Preconference Training Die Teilnehmerzahl ist begrenzt! 09:00-15:30 GLP für Einsteiger Harston, Stephen; Ehrenpräsident der DGGF, Germany 09:00-17:30 Kommunikationsstrategien im Audit Meyer, Monika; Kommunikationstrainerin; Coach und Moderator bei AuditDialogConcept, Germany 09:00-17:30 Auditor in der Pharmakovigilanz Scholz, Bianca; Scholz Consulting, Bensheim, Germany 18:00 Conference registration Donnerstag, 22. September :00-11:00 Stream: Plenary Session GxP_1 Chairs: König, Steffen, DGGF, Germany 09:00-09:15 Opening address König, Steffen, DGGF President 09:15-10:30 N., N.; xxx, ooo, Germany 10:30-11:00 Break 11:00-12:30 Stream: Plenary Session GxP_2 Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany 11:00-12:00 Lean Six Sigma meets the Regulated Industry Jakob, Kerstin; Penta-Plan Business Empowerment GmbH, Ulm, Germany 12:00-12:30 N., N.; xxx, 000, Germany 12:30-14:00 Lunch 14:00-16:00 Stream: Good Laboratory Practice - Session 1 Chair: Neuss, Jürgen; Bayer CropScience AG, Frankfurt am Main, Germany 14:00-14:45 Workflow for implementation of complex computerized Assay Technologies into a regulated (GLP) environment Ratering, Sonja; Sanofi-Aventis, Frankfurt, Germany Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 2 von 11

3 Programm 14:45-15:30 N., N.; ccc, ooo, lll 15:30-16:00 Break 16:00-17:30 Stream: Good Laboratory Practice - Session 2 Chair: Hermann, Frauke; Envigo CRS GmbH, Rossdorf, Germany 16:00-16:45 16:45-17:30 Risk Based Auditing - Can it work for you? (Title might change a little bit) Gillbanks, Linzi; Covance Laboratories, Harrogate, United Kingdom 14:00-16:00 Stream: Good Clinical Practice - Session 1 Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany 14:00-14:45 Clinical Trials - Status and implementation of the new regulations Ruppert, Thorsten; VFA, Berlin, Germany 14:45-15:30 The day after..save Harbor-consequences and gaps Westphal, Vanessa; Merck KGAa, Darmstadt, Germany 15:30-16:00 Break 16:00-17:30 Stream: Good Clinical Practice - Session 2 Chair: König, Steffen; IST GmbH, Mannheim, Germany 16:00-16:45 Presentation and/or Workshop / Discussion 16:45-17:30 Presentation and/or Workshop / Discussion 14:00-16:00 Stream: Information Technology - Session 1 Chair: Morgenthaler, Helmuth; DGGF, Ludwigshafen, Germany 14:00-14:45 Cloud Computing & GxP: Eine Betrachtung zu Chancen und Risiken sowie Vorstellung von Praxisbeispielen Tryba, Alexander; MAIN5 GmbH & Co.KGaA, Frankfurt, Germany 14:45-15:30 Open Microphone Discussion 15:30-16:00 Break 16:00-17:30 Stream: Good Manufacturing Practice - Session 1 Chair: Frankenberg, Nadine; synlab pharma institute AG, Birsfelden, Switzerland Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 3 von 11

4 Programm 16:00-16:45 IT Infrastructure Qualification in GxP environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany 16:45-17:30 Modern Forms of GMP-Trainings and their Chances Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany Freitag, 23. September :00-11:00 Stream: Good Laboratory Practice - Session 3 Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany 09:00-09:45 ELN goes GLP Verhaege, Tom; Johnson & Johnson, Antwerpen, Belgien 09:45-10:30 Good Scientific Practice - Quality Governance in pre-clinical biomedical research Emmerich, Christoph; PAASP GmbH, Heidelberg, Germany 10:30-11:00 Break 09:00-11:00 Stream: Good Vigilance Practice - Session 1 Chair: Scholz, Bianca; Scholz Consulting, Bensheim, Germany 09:00-09:45 DHPC-Direct HealthCare Professional Communication and educational material Palissa, Harriet; BfArM, Bonn, Germany 09:45-10:30 Risk based PV audit planning demonstrated with distributor audits worlwide Danila-Luersen, Christine; CSL Behring, Marburg, Germany 10:30-11:00 Break 09:00-11:00 Stream: Good Manufacturing Practice - Session 2 Chair: Frankenberg, Nadine; synlab pharma institute AG, Birsfelden, Switzerland 09:00-09:45 Data Trending in Quality Control Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany 09:45-10:30 Round Table Discussion Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany 10:30-11:00 Break Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 4 von 11

5 Programm 11:00-12:45 Stream: Plenary Session GxP_3 Chair: Schepers, Ulrich; BASF SE, Limburgerhof, Germany 11:00-11:45 Do CAPAs improve quality? Weber, Melanie; Pietrek Associates GmbH, Weinheim, Germany 11:45-12:30 Ensuring Data Integrity Mitigation of Risks Schumacher, Wolfgang; Basel 12:45-13:45 Lunch - must be preordered at CSM! 13:45-14:45 DGGF Members' Meeting Chairs: König, Steffen, DGGF Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 5 von 11

6 Vorträge Auditor in der Pharmakovigilanz Scholz, Bianca; Scholz Consulting, Bensheim, Germany Mittwoch, 21. September 2016, 09:00-17:30 Clinical Trials - Status and implementation of the new regulations Ruppert, Thorsten; VFA, Berlin, Germany Cloud Computing & GxP: Eine Betrachtung zu Chancen und Risiken sowie Vorstellung von Praxisbeispielen Tryba, Alexander; MAIN5 GmbH & Co.KGaA, Frankfurt, Germany Data Trending in Quality Control Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany DHPC-Direct HealthCare Professional Communication and educational material Palissa, Harriet; BfArM, Bonn, Germany Do CAPAs improve quality? Weber, Melanie; Pietrek Associates GmbH, Weinheim, Germany Freitag, 23. September 2016, 11:00-11:45 ELN goes GLP Verhaege, Tom; Johnson & Johnson, Antwerpen, Belgien Ensuring Data Integrity Mitigation of Risks Schumacher, Wolfgang; Basel Freitag, 23. September 2016, 11:45-12:30 GLP für Einsteiger Harston, Stephen; Ehrenpräsident der DGGF, Germany Mittwoch, 21. September 2016, 09:00-15:30 Good Scientific Practice - Quality Governance in pre-clinical biomedical research Emmerich, Christoph; PAASP GmbH, Heidelberg, Germany IT Infrastructure Qualification in GxP environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Kommunikationsstrategien im Audit Meyer, Monika; Kommunikationstrainerin; Coach und Moderator bei AuditDialogConcept, Germany Mittwoch, 21. September 2016, 09:00-17:30 Lean Six Sigma meets the Regulated Industry Jakob, Kerstin; Penta-Plan Business Empowerment GmbH, Ulm, Germany Donnerstag, 22. September 2016, 11:00-12:00 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 6 von 11

7 Vorträge Modern Forms of GMP-Trainings and their Chances Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany N., N.; xxx, 000, Germany Donnerstag, 22. September 2016, 12:00-12:30 N., N.; ccc, ooo, lll Donnerstag, 22. September 2016, 14:45-15:30 N., N.; xxx, ooo, Germany Donnerstag, 22. September 2016, 09:15-10:30 Open Microphone Discussion Donnerstag, 22. September 2016, 14:45-15:30 Presentation and/or Workshop / Discussion Presentation and/or Workshop / Discussion Risk Based Auditing - Can it work for you? (Title might change a little bit) Gillbanks, Linzi; Covance Laboratories, Harrogate, United Kingdom Risk based PV audit planning demonstrated with distributor audits worlwide Danila-Luersen, Christine; CSL Behring, Marburg, Germany Round Table Discussion Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany The day after..save Harbor-consequences and gaps Westphal, Vanessa; Merck KGAa, Darmstadt, Germany Donnerstag, 22. September 2016, 14:45-15:30 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 7 von 11

8 Vorträge Workflow for implementation of complex computerized Assay Technologies into a regulated (GLP) environment Ratering, Sonja; Sanofi-Aventis, Frankfurt, Germany Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 8 von 11

9 Referenten Danila-Luersen, Christine; CSL Behring, Marburg, Germany Risk based PV audit planning demonstrated with distributor audits worlwide Emmerich, Christoph; PAASP GmbH, Heidelberg, Germany Good Scientific Practice - Quality Governance in pre-clinical biomedical research Gillbanks, Linzi; Covance Laboratories, Harrogate, United Kingdom Risk Based Auditing - Can it work for you? (Title might change a little bit) Harston, Stephen; Ehrenpräsident der DGGF, Germany GLP für Einsteiger Mittwoch, 21. September 2016, 09:00-15:30 Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany IT Infrastructure Qualification in GxP environment Round Table Discussion Jakob, Kerstin; Penta-Plan Business Empowerment GmbH, Ulm, Germany Lean Six Sigma meets the Regulated Industry Donnerstag, 22. September 2016, 11:00-12:00 König, Steffen, DGGF President Opening address Donnerstag, 22. September 2016, 09:00-09:15 Meyer, Monika; Kommunikationstrainerin; Coach und Moderator bei AuditDialogConcept, Germany Kommunikationsstrategien im Audit Mittwoch, 21. September 2016, 09:00-17:30 N., N.; ccc, ooo, lll Donnerstag, 22. September 2016, 14:45-15:30 N., N.; xxx, 000, Germany Donnerstag, 22. September 2016, 12:00-12:30 N., N.; xxx, ooo, Germany Donnerstag, 22. September 2016, 09:15-10:30 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 9 von 11

10 Referenten Presentation and/or Workshop / Discussion Presentation and/or Workshop / Discussion Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany Modern Forms of GMP-Trainings and their Chances Round Table Discussion Palissa, Harriet; BfArM, Bonn, Germany DHPC-Direct HealthCare Professional Communication and educational material Ratering, Sonja; Sanofi-Aventis, Frankfurt, Germany Workflow for implementation of complex computerized Assay Technologies into a regulated (GLP) environment Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany Data Trending in Quality Control Round Table Discussion Ruppert, Thorsten; VFA, Berlin, Germany Clinical Trials - Status and implementation of the new regulations Scholz, Bianca; Scholz Consulting, Bensheim, Germany Auditor in der Pharmakovigilanz Mittwoch, 21. September 2016, 09:00-17:30 Schumacher, Wolfgang; Basel Ensuring Data Integrity Mitigation of Risks Freitag, 23. September 2016, 11:45-12:30 Tryba, Alexander; MAIN5 GmbH & Co.KGaA, Frankfurt, Germany Cloud Computing & GxP: Eine Betrachtung zu Chancen und Risiken sowie Vorstellung von Praxisbeispielen Verhaege, Tom; Johnson & Johnson, Antwerpen, Belgien Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 10 von 11

11 Referenten ELN goes GLP Weber, Melanie; Pietrek Associates GmbH, Weinheim, Germany Do CAPAs improve quality? Freitag, 23. September 2016, 11:00-11:45 Westphal, Vanessa; Merck KGAa, Darmstadt, Germany The day after..save Harbor-consequences and gaps Donnerstag, 22. September 2016, 14:45-15:30 Deutsche Gesellschaft für Gute Forschungspraxis e.v. Seite 11 von 11