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: tagung@dggf.de
Online Registration is available by CSM
Current program information
Please find here information on exhibition and sponsoring opportunities.
...
Programme
Wednesday, September 21, 2016
9:00 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, 2016
9:00 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
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
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, 2016
9:00 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
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
Titles
Auditor in der Pharmakovigilanz
Scholz, Bianca; Scholz Consulting, Bensheim, Germany
Wednesday, September 21, 2016, 9:00 AM - 5:30 PM
Audits von IT-Systemen
Wallstein, Markus;
Brooks, Marc E.; Elderbrook Solution GmbH, Langenargen, Germany
Wednesday, September 21, 2016, 9:00 AM - 5:30 PM
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
Thursday, September 22, 2016, 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
Thursday, September 22, 2016, 2:00 PM - 2:45 PM
DHPC-Direct HealthCare Professional Communication and educational material
Palissa, Harriet; BfArM, Bonn, Germany
Friday, September 23, 2016, 9:00 AM - 9:45 AM
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
Friday, September 23, 2016, 9:00 AM - 9:45 AM
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
Titles
Good Scientific Practice - Quality Governance in pre-clinical biomedical research
Emmerich, Christoph; PAASP GmbH, Heidelberg, Germany
Friday, September 23, 2016, 9:45 AM - 10:30 AM
IT Infrastructure Qualification in GxP environment
Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany
Thursday, September 22, 2016, 4:00 PM - 4:45 PM
Kommunikationsstrategien im Audit
Meyer, Monika; Kommunikationstrainerin; Coach und Moderator bei AuditDialogConcept, Germany
Wednesday, September 21, 2016, 9:00 AM - 5:30 PM
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
Thursday, September 22, 2016, 4:45 PM - 5:30 PM
OECD/EU GLP News
Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany
Thursday, September 22, 2016, 4:00 PM - 4:45 PM
Open Microphone Discussion
Thursday, September 22, 2016, 2:45 PM - 3:30 PM
Presentation and/or Workshop / Discussion
N.N.
Thursday, September 22, 2016, 4:00 PM - 4:45 PM
Presentation and/or Workshop / Discussion
N.N.
Thursday, September 22, 2016, 4:45 PM - 5:30 PM
Risk Based Auditing - Can it work for you?
Gillbanks, Linzi; Covance Laboratories, Harrogate, United Kingdom
Thursday, September 22, 2016, 4:45 PM - 5:30 PM
Risk based PV audit planning demonstrated with distributor audits worldwide
Danila-Luersen, Christine; CSL Behring, Marburg, Germany
Friday, September 23, 2016, 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
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
Friday, September 23, 2016, 9:00 AM - 9:45 AM
Workflow for implementation of complex computerized Assay Technologies into a regulated (GLP)
environment
Ratering, Sonja; Sanofi-Aventis, Frankfurt, Germany
Thursday, September 22, 2016, 2:00 PM - 2:45 PM
You never achieve real GxP compliance without knowledge management and quality culture!
Peither, Thomas; Maas & Peither AG, Schopfheim, Germany
Presenters
Brooks, Marc E.; Elderbrook Solution GmbH, Langenargen, Germany
Audits von IT-Systemen
Wednesday, September 21, 2016, 9:00 AM - 5:30 PM
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
Thursday, September 22, 2016, 4:00 PM - 4:45 PM
Danila-Luersen, Christine; CSL Behring, Marburg, Germany
Risk based PV audit planning demonstrated with distributor audits worldwide
Friday, September 23, 2016, 9:45 AM - 10:30 AM
Emmerich, Christoph; PAASP GmbH, Heidelberg, Germany
Good Scientific Practice - Quality Governance in pre-clinical biomedical research
Friday, September 23, 2016, 9:45 AM - 10:30 AM
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?
Thursday, September 22, 2016, 4:45 PM - 5:30 PM
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
Thursday, September 22, 2016, 4:00 PM - 4:45 PM
Round Table Discussion
Friday, September 23, 2016, 9:45 AM - 10:30 AM
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
Presenters
Meyer, Monika; Kommunikationstrainerin; Coach und Moderator bei AuditDialogConcept,
Germany
Kommunikationsstrategien im Audit
Wednesday, September 21, 2016, 9:00 AM - 5:30 PM
N.N.
Presentation and/or Workshop / Discussion
Thursday, September 22, 2016, 4:45 PM - 5:30 PM
Presentation and/or Workshop / Discussion
Thursday, September 22, 2016, 4:00 PM - 4:45 PM
Nedvidek, Wolfgang; PTS Training Service, Arnsberg, Germany
Modern Forms of GMP-Trainings and their Chances
Thursday, September 22, 2016, 4:45 PM - 5:30 PM
Round Table Discussion
Friday, September 23, 2016, 9:45 AM - 10:30 AM
Palissa, Harriet; BfArM, Bonn, Germany
DHPC-Direct HealthCare Professional Communication and educational material
Friday, September 23, 2016, 9:00 AM - 9:45 AM
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
Thursday, September 22, 2016, 2:00 PM - 2:45 PM
Renger, Bernd; Bernd Renger Consulting, Radolfzell, Germany
Round Table Discussion
Friday, September 23, 2016, 9:45 AM - 10:30 AM
Trending of GMP Data
Friday, September 23, 2016, 9:00 AM - 9:45 AM
Ruppert, Thorsten; VFA, Berlin , Germany
Clinical Trials - Status and implementation of the new regulations
Thursday, September 22, 2016, 2:00 PM - 2:45 PM
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
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
Thursday, September 22, 2016, 2:00 PM - 2:45 PM
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.
Friday, September 23, 2016, 9:00 AM - 9:45 AM
Wallstein, Markus;
Audits von IT-Systemen
Wednesday, September 21, 2016, 9:00 AM - 5:30 PM
Weber, Melanie; Pietrek Associates GmbH, Weinheim, Germany
CAPA effectiveness checks - a valuable tool?
