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Meetings/Annual Meeting 2017

22nd Annual Meeting of GQMA

The 22nd International Meeting took place September 21st - 22nd, Maritim Hotel, Würzburg, Germany

Access to our delegate handbook.

Programme Titles Presenters

Wednesday, September 20, 2017
9:00 AM - 5:30 PMPreconference Training
Die Teilnehmerzahl ist begrenzt!
Auf dem Anmeldeformular ist eine separate Anmeldung erforderlich.

9:00 AM - 3:30 PMGLP für Einsteiger
Harston, Stephen; Ehrenpräsident der GQMA, Germany
9:00 AM - 5:30 PMKommunikationsstrategien im Audit
Meyer, Monika; AuditDialogConcept, Germany
6:00 PMConference registration

Thursday, September 21, 2017
9:00 AM - 11:00 AMPlenary Session GxP_1
Chairs: König, Steffen; GQMA, Berlin, Germany
9:00 AM - 9:15 AMOpening address
König, Steffen, GQMA President

9:15 AM - 10:30 AMWe dice a study
Christensen, Björn; University of Applied Science, Kiel, Germany
10:30 AM - 11:00 AMBreak

11:00 AM - 12:30 PMPlenary Session GxP_2 - Data Integrity Basics
Chair: Morgenthaler, Helmuth; GQMA, Ludwigshafen, Germany
11:00 AM - 11:45 AMThe OECD Advisory Doc. No. 17 – Advantages, Disadvantages and Challenges
Morgenthaler, Helmuth; GQMA, Ludwigshafen, Germany
11:45 AM - 12:30 PMMoving From Big Data to Big Analysis
Little, Eric; Osthus, Melbourne, USA

12:30 PM - 2:00 PMLunch

2:00 PM - 4:00 PMSession: Analytics_1
Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany
2:00 PM - 2:45 PMCompliant E-Data Retention, Integration and Collaboration for LC/MS-MS Data using the AnIML Standard
Schäfer, Burkhard; BSSN Software GmbH; Darmstadt, Germany

2:45 PM - 3:30 PMGLP for Sponsors – why and how?
Fröhlke, Erinita; GLP-Consulting; Münster, Germany
3:30 PM - 4:00 PMBreak

4:00 PM - 4:45 PMSession: Good Laboratory Practice_1
Chair: Hermann, Frauke; Envigo CRS GmbH, Rossdorf, Germany
4:00 PM - 4:45 PMUpdate on 21 part 58 draft GLP. Main proposed changes and their possible impact.
Grande, Alessandra; Merck Biopharma, Turin, Italy
2:00 PM - 4:00 PMSession: Risk Management_1
Chair: Pillwein, Marion; Merck KGaA, Darmstadt, Germany
2:00 PM - 2:45 PMISO 9001:2015 within clinical trial management – an approach for risk based quality management
Schaaf, Stefan; Q-FINITY, Dillingen, Germany
2:45 PM - 3:30 PMPractical Examples for Risk Management
König, Steffen; IST GmbH; Mannheim, Germany
3:30 PM - 4:00 PMBreak

4:00 PM - 5:30 PMSession: Good Vigilance Practice_1
Chair: Scholz, Bianca; ScholzPharma GmbH, Bensheim, Germany
4:00 PM - 4:45 PME2B R3 Implementation and associated requirements
Alesik, Eva; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
4:45 PM - 5:30 PMRisk Based Audit Program - the Art of Selecting the Right Targets.
Weber, Melanie; Pietrek Associates, Weinheim, Germany
2:00 PM - 4:00 PMSession: Good Distribution Practice_1
Chair: Niggemann, Björn; ELPRO-BUCHS AG, Buchs, SG, Switzerland
2:00 PM - 2:45 PMJust paying attention to certificates means: missing the essentials! - Qualification of forwarders, carriers, and subcontractors.
Specht, Christian; EIPL European Institute for Pharma Logistics GmbH, Korntal-Münchingen (Stuttgart), Germany

2:45 PM - 3:30 PMThe last mile of drug supply in clinical trials
Behrend, Bardo; Nextpharma, Göttingen
3:30 PM - 4:00 PMBreak

4:00 PM - 5:30 PMSession: Good Manufacturing Practice_1
Chair: Frankenberg, Nadine; synlab pharma institute AG , Birsfelden, Switzerland
4:00 PM - 4:45 PMFinding the Path to Data Integrity in aGMP environment
Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany
Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany

4:45 PM - 5:30 PMContinuation: Finding the Path to Data Integrity in aGMP environment
Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany
Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany

Friday, September 22, 2017
9:00 AM - 11:00 AMSession: Good Laboratory Practice_2
Chair: Neuss, Jürgen; Bayer AG, Frankfurt, Germany
9:00 AM - 9:45 AMLaboratories are going “Paperless”: Electronic Raw Data Archiving in practice
Schölzke, Brunhilde; Merck Sharpe & Dhome (MSD), Schwabenheim, Germany
9:45 AM - 10:30 AMIs our GLP system suitable for the challenges of recent developments? GLP News, especially focussing on New Techniques
Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany
10:30 AM - 11:00 AMBreak

11:00 AM - 12:30 PMSession: Good Laboratory Practice_3
Chair: Schepers, Ulrich; BASF SE, Limburgerhof, Germany
11:00 AM - 11:45 AMGLP Round Table Discussion
Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany
Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany
Uhde, Holger; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany

11:45 AM - 12:30 PMGLP Round Table Discussion (continued)

9:00 AM - 11:00 AMSession: Good Clinical Practice_1
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany

9:00 AM - 9:45 AMElectronic Informed Consent
Stanbrook, Rebecca; Novartis, Basel, Switzerland
9:45 AM - 10:30 AMArchiving of eClinical Systems and Data
Summa, Wolfgang; Merck, Darmstadt, Germany

10:30 AM - 11:00 AMBreak

11:00 AM - 12:30 PMSession: Good Clinical Practice_2
Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany
11:00 AM - 11:45 AMe-Data - regulatory expectations
Bregnhøj, Lisbeth and Ib Alstrup; Danish Medicine Agency, Copenhagen, Denmark
11:45 AM - 12:30 PMGCP round table
Summa, Wolfgang; Merck, Darmstadt, Germany
Bregnhøj, Lisbeth; Danish Medicine Agency, Copenhagen, Denmark
Alstrup, Ib; Danish Medicine Agency, Copenhagen, Denmark


11:00 AM - 12:30 PMSession GxP_3
Chair: Frankenberg, Nadine; synlab pharma institute AG , Birsfelden, Switzerland
11:00 AM - 11:45 AMQuality Management in the Digital Age
Gaertner, Robert; Veeva Systems, Hofheim, Germany
11:45 AM - 12:30 PMRoll out and implementation of a globally harmonized eQMS
Jachmann, Verena; Fresenius Kabi Deutschland GmbH, Oberursel; Germany
Schmidt, Sabine; MAIN5 GmbH, Frankfurt, Germany

12:30 PM - 2:00 PMLunch

2:00 PM - 3:00 PMPlenary Session GxP_4
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany
2:00 PM - 2:45 PMPatient Centricity: How to successfully involve patients into clinical development
Keiper, Tanja; Merck KGaA; Darmstadt, Germany
2:45 PM - 3:00 PMClosing Remarks
König, Steffen; GQMA
3:00 PM - 3:15 PMShort break

3:15 PM - 4:15 PMGQMA Members' Meeting
Chairs: König, Steffen, GQMA
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