21st Annual Meeting of DGGF

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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.

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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

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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

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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

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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

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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

(7)

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

(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

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

(9)

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

(10)

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

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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?

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