21st Annual Meeting of DGGF

Transcription

1 The 21st International Meeting 2016 will take place September 22nd - 23rd, Maritim Hotel, Bonn, Germany There will be simultaneous translation from German to English (and vice versa) in the GxP, GCP and GLP Sessions! For any further questions please contact: [email protected] Online Registration is available by CSM Current program information Please find here information on exhibition and sponsoring opportunities.... German Society for Good Research Practice (DGGF e.v.) Page 1 of 11

2 Programme Wednesday, September 21, :00 AM - 5:30 PM Preconference Training Die Teilnehmerzahl ist begrenzt! Auf dem Anmeldeformular ist eine separate Anmeldung erforderlich. Bitte beachten Sie, dass das IT Seminar nicht im Tagungshotel stattfindet. 9:00 AM - 3:30 PM GLP für Einsteiger Harston, Stephen; Ehrenpräsident der DGGF, Germany 9:00 AM - 5:30 PM Kommunikationsstrategien im Audit Meyer, Monika; Kommunikationstrainerin; Coach und Moderator bei AuditDialogConcept, Germany 9:00 AM - 5:30 PM Auditor in der Pharmakovigilanz Scholz, Bianca; Scholz Consulting, Bensheim, Germany 9:00 AM - 5:30 PM Audits von IT-Systemen Wallstein, Markus; Brooks, Marc E.; Elderbrook Solution GmbH, Langenargen, Germany 6:00 PM Conference registration Thursday, September 22, :00 AM - 11:00 AM Stream: Plenary Session GxP_1 Chairs: Horstmann, Andreas; Strathmann GmbH, Hamburg, Germany 9:00 AM - 9:15 AM Opening address König, Steffen, DGGF President 9:15 AM - 10:30 AM You never achieve real GxP compliance without knowledge management and quality culture! Peither, Thomas; Maas & Peither AG, Schopfheim, Germany 10:30 AM - 11:00 AM Break 11:00 AM - 12:30 PM Stream: Plenary Session GxP_2 Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany 11:00 AM - 12:00 PM Lean Six Sigma meets the Regulated Industry Jakob, Kerstin; Penta-Plan Business Empowerment GmbH, Ulm, Germany 12:00 PM - 12:30 PM Business Oversight on Computer System Validation It s more than defining User Requirements Gerber, Claudia; Elderbrook solutions GmbH, Langenargen, Germany 12:30 PM - 2:00 PM Lunch German Society for Good Research Practice (DGGF e.v.) Page 2 of 11

3 Programme 2:00 PM - 4:00 PM Stream: Good Laboratory Practice - Session 1 Chair: Neuss, Jürgen; Bayer CropScience AG, Frankfurt am Main, Germany 2:00 PM - 2:45 PM Workflow for implementation of complex computerized Assay Technologies into a regulated (GLP) environment Ratering, Sonja; Sanofi-Aventis, Frankfurt, Germany 2:45 PM - 3:30 PM Electronic Raw Data Workflows in bioanalytical labs and their obstacles Schmidt, Ronald; Sanofi-Aventis, Frankfurt, Germany 3:30 PM - 4:00 PM Break 4:00 PM - 5:30 PM Stream: Good Laboratory Practice - Session 2 Chair: Hermann, Frauke; Envigo CRS GmbH, Rossdorf, Germany 4:00 PM - 4:45 PM OECD/EU GLP News Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany 4:45 PM - 5:30 PM Risk Based Auditing - Can it work for you? Gillbanks, Linzi; Covance Laboratories, Harrogate, United Kingdom 2:00 PM - 4:00 PM Stream: Good Clinical Practice - Session 1 Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany 2:00 PM - 2:45 PM Clinical Trials - Status and implementation of the new regulations Ruppert, Thorsten; VFA, Berlin, Germany 2:45 PM - 3:30 PM The day after Safe Harbour - Privacy Shield and General Data Privacy Regulation and their implications from the perspective of a pharmaceutical company Bulicz, Natalia; Merck KGAa, Darmstadt, Germany 3:30 PM - 4:00 PM Break 4:00 PM - 5:30 PM Stream: Good Clinical Practice - Session 2 Chair: König, Steffen; IST GmbH, Mannheim, Germany 4:00 PM - 4:45 PM Presentation and/or Workshop / Discussion N.N. 4:45 PM - 5:30 PM Presentation and/or Workshop / Discussion N.N. 2:00 PM - 4:00 PM Stream: Information Technology - Session 1 Chair: Morgenthaler, Helmuth; DGGF, Ludwigshafen, Germany German Society for Good Research Practice (DGGF e.v.) Page 3 of 11

4 Programme 2:00 PM - 2:45 PM Cloud Computing & GxP: Eine Betrachtung zu Chancen und Risiken sowie Vorstellung von Praxisbeispielen Tryba, Alexander; MAIN5 GmbH & Co.KGaA, Frankfurt, Germany 2:45 PM - 3:30 PM Open Microphone Discussion 3:30 PM - 4:00 PM Break 4:00 PM - 5:30 PM Stream: Good Manufacturing Practice - Session 1 Chair: Frankenberg, Nadine; synlab pharma institute AG, Birsfelden, Switzerland 4:00 PM - 4:45 PM IT Infrastructure Qualification in GxP environment Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany 4:45 PM - 5:30 PM Modern Forms of GMP-Trainings and their Chances Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany Friday, September 23, :00 AM - 11:00 AM Stream: Good Laboratory Practice - Session 3 Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany 9:00 AM - 9:45 AM ELN goes GLP: the journey of implementing an eln system in a regulated environment - experiences at the bioanalytical lab of Janssen Research and Development. Verhaege, Tom; Johnson & Johnson, Antwerpen, Belgien 9:45 AM - 10:30 AM Good Scientific Practice - Quality Governance in pre-clinical biomedical research Emmerich, Christoph; PAASP GmbH, Heidelberg, Germany 10:30 AM - 11:00 AM Break 9:00 AM - 11:00 AM Stream: Good Vigilance Practice - Session 1 Chair: Scholz, Bianca; Scholz Consulting, Bensheim, Germany 9:00 AM - 9:45 AM DHPC-Direct HealthCare Professional Communication and educational material Palissa, Harriet; BfArM, Bonn, Germany 9:45 AM - 10:30 AM Risk based PV audit planning demonstrated with distributor audits worldwide Danila-Luersen, Christine; CSL Behring, Marburg, Germany 10:30 AM - 11:00 AM Break German Society for Good Research Practice (DGGF e.v.) Page 4 of 11

5 Programme 9:00 AM - 11:00 AM Stream: Good Manufacturing Practice - Session 2 Chair: Frankenberg, Nadine; synlab pharma institute AG, Birsfelden, Switzerland 9:00 AM - 9:45 AM Trending of GMP Data Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany 9:45 AM - 10:30 AM 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 AM - 11:00 AM Break 11:00 AM - 12:45 PM Stream: Plenary Session GxP_3 Chair: Schepers, Ulrich; BASF SE, Limburgerhof, Germany 11:00 AM - 11:45 AM CAPA effectiveness checks - a valuable tool? Weber, Melanie; Pietrek Associates GmbH, Weinheim, Germany 11:45 AM - 12:30 PM Ensuring Data Integrity Mitigation of Risks Schumacher, Wolfgang; Hoffmann-La Roche, Basel, Switzerland 12:45 PM - 1:45 PM Lunch 1:45 PM - 2:45 PM DGGF Members' Meeting Chairs: König, Steffen, DGGF German Society for Good Research Practice (DGGF e.v.) Page 5 of 11

6 Titles Auditor in der Pharmakovigilanz Scholz, Bianca; Scholz Consulting, Bensheim, Germany Audits von IT-Systemen Wallstein, Markus; Brooks, Marc E.; Elderbrook Solution GmbH, Langenargen, Germany Business Oversight on Computer System Validation It s more than defining User Requirements Gerber, Claudia; Elderbrook solutions GmbH, Langenargen, Germany Thursday, September 22, 2016, 12:00 PM - 12:30 PM CAPA effectiveness checks - a valuable tool? Weber, Melanie; Pietrek Associates GmbH, Weinheim, Germany Friday, September 23, 2016, 11:00 AM - 11:45 AM 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 DHPC-Direct HealthCare Professional Communication and educational material Palissa, Harriet; BfArM, Bonn, Germany Electronic Raw Data Workflows in bioanalytical labs and their obstacles Schmidt, Ronald; Sanofi-Aventis, Frankfurt, Germany Thursday, September 22, 2016, 2:45 PM - 3:30 PM ELN goes GLP: the journey of implementing an eln system in a regulated environment - experiences at the bioanalytical lab of Janssen Research and Development. Verhaege, Tom; Johnson & Johnson, Antwerpen, Belgien Ensuring Data Integrity Mitigation of Risks Schumacher, Wolfgang; Hoffmann-La Roche, Basel, Switzerland Friday, September 23, 2016, 11:45 AM - 12:30 PM GLP für Einsteiger Harston, Stephen; Ehrenpräsident der DGGF, Germany Wednesday, September 21, 2016, 9:00 AM - 3:30 PM German Society for Good Research Practice (DGGF e.v.) Page 6 of 11

7 Titles 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 Lean Six Sigma meets the Regulated Industry Jakob, Kerstin; Penta-Plan Business Empowerment GmbH, Ulm, Germany Thursday, September 22, 2016, 11:00 AM - 12:00 PM Modern Forms of GMP-Trainings and their Chances Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany OECD/EU GLP News Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany Open Microphone Discussion Thursday, September 22, 2016, 2:45 PM - 3:30 PM Presentation and/or Workshop / Discussion N.N. Presentation and/or Workshop / Discussion N.N. Risk Based Auditing - Can it work for you? Gillbanks, Linzi; Covance Laboratories, Harrogate, United Kingdom Risk based PV audit planning demonstrated with distributor audits worldwide 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 German Society for Good Research Practice (DGGF e.v.) Page 7 of 11

8 Titles The day after Safe Harbour - Privacy Shield and General Data Privacy Regulation and their implications from the perspective of a pharmaceutical company Bulicz, Natalia; Merck KGAa, Darmstadt, Germany Thursday, September 22, 2016, 2:45 PM - 3:30 PM Trending of GMP Data Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany Workflow for implementation of complex computerized Assay Technologies into a regulated (GLP) environment Ratering, Sonja; Sanofi-Aventis, Frankfurt, Germany You never achieve real GxP compliance without knowledge management and quality culture! Peither, Thomas; Maas & Peither AG, Schopfheim, Germany Thursday, September 22, 2016, 9:15 AM - 10:30 AM German Society for Good Research Practice (DGGF e.v.) Page 8 of 11

9 Presenters Brooks, Marc E.; Elderbrook Solution GmbH, Langenargen, Germany Audits von IT-Systemen Bulicz, Natalia; Merck KGAa, Darmstadt, Germany The day after Safe Harbour - Privacy Shield and General Data Privacy Regulation and their implications from the perspective of a pharmaceutical company Thursday, September 22, 2016, 2:45 PM - 3:30 PM Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany OECD/EU GLP News Danila-Luersen, Christine; CSL Behring, Marburg, Germany Risk based PV audit planning demonstrated with distributor audits worldwide Emmerich, Christoph; PAASP GmbH, Heidelberg, Germany Good Scientific Practice - Quality Governance in pre-clinical biomedical research Gerber, Claudia; Elderbrook solutions GmbH, Langenargen, Germany Business Oversight on Computer System Validation It s more than defining User Requirements Thursday, September 22, 2016, 12:00 PM - 12:30 PM Gillbanks, Linzi; Covance Laboratories, Harrogate, United Kingdom Risk Based Auditing - Can it work for you? Harston, Stephen; Ehrenpräsident der DGGF, Germany GLP für Einsteiger Wednesday, September 21, 2016, 9:00 AM - 3:30 PM 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 Thursday, September 22, 2016, 11:00 AM - 12:00 PM König, Steffen, DGGF President Opening address Thursday, September 22, 2016, 9:00 AM - 9:15 AM German Society for Good Research Practice (DGGF e.v.) Page 9 of 11

10 Presenters Meyer, Monika; Kommunikationstrainerin; Coach und Moderator bei AuditDialogConcept, Germany Kommunikationsstrategien im Audit N.N. 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 Peither, Thomas; Maas & Peither AG, Schopfheim, Germany You never achieve real GxP compliance without knowledge management and quality culture! Thursday, September 22, 2016, 9:15 AM - 10:30 AM 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 Round Table Discussion Trending of GMP Data Ruppert, Thorsten; VFA, Berlin, Germany Clinical Trials - Status and implementation of the new regulations Schmidt, Ronald; Sanofi-Aventis, Frankfurt, Germany Electronic Raw Data Workflows in bioanalytical labs and their obstacles Thursday, September 22, 2016, 2:45 PM - 3:30 PM Scholz, Bianca; Scholz Consulting, Bensheim, Germany Auditor in der Pharmakovigilanz German Society for Good Research Practice (DGGF e.v.) Page 10 of 11

11 Presenters Schumacher, Wolfgang; Hoffmann-La Roche, Basel, Switzerland Ensuring Data Integrity Mitigation of Risks Friday, September 23, 2016, 11:45 AM - 12:30 PM 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 ELN goes GLP: the journey of implementing an eln system in a regulated environment - experiences at the bioanalytical lab of Janssen Research and Development. Wallstein, Markus; Audits von IT-Systemen Weber, Melanie; Pietrek Associates GmbH, Weinheim, Germany CAPA effectiveness checks - a valuable tool? Friday, September 23, 2016, 11:00 AM - 11:45 AM German Society for Good Research Practice (DGGF e.v.) Page 11 of 11