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Tagungen/Jahrestagung 2017

22. Jahrestagung der GQMA


Die 22. Jahrestagung 2017 fand vom 21. bis 22. September 2017 im Maritim Hotel, Würzburg statt.
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Ab 15.09.2017 bis 15.01.2018 stehen den Tagungsteilnehmern die zur Veröffentlichung freigegebenen Präsentationen als pdf Dateien auf dieser Seite zur Verfügung. Sie benötigen dazu das von CSM versendete Passwort.

Anbei erhalten Sie die Möglichkeit, auf die Tagungsbroschüre zuzugreifen.

Programm Vorträge Referenten

Mittwoch, 20. September 2017
09:00 - 17:30Preconference Training
Die Teilnehmerzahl ist begrenzt!
Auf dem Anmeldeformular ist eine separate Anmeldung erforderlich.

09:00 - 15:30GLP für Einsteiger
Harston, Stephen; Ehrenpräsident der GQMA, Germany
09:00 - 17:30Kommunikationsstrategien im Audit
Meyer, Monika; AuditDialogConcept, Germany
18:00Conference registration

Donnerstag, 21. September 2017
09:00 - 11:00Plenary Session GxP_1
Chairs: König, Steffen; GQMA, Berlin, Germany
09:00 - 09:15Opening address
König, Steffen, GQMA President

09:15 - 10:30We dice a study
Christensen, Björn; University of Applied Science, Kiel, Germany
10:30 - 11:00Break

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

12:30 - 14:00Lunch

14:00 - 16:00Session: Analytics_1
Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany
14:00 - 14:45Compliant E-Data Retention, Integration and Collaboration for LC/MS-MS Data using the AnIML Standard
Schäfer, Burkhard; BSSN Software GmbH; Darmstadt, Germany

14:45 - 15:30GLP for Sponsors – why and how?
Fröhlke, Erinita; GLP-Consulting; Münster, Germany
15:30 - 16:00Break

16:00 - 16:45Session: Good Laboratory Practice_1
Chair: Hermann, Frauke; Envigo CRS GmbH, Rossdorf, Germany
16:00 - 16:45Update on 21 part 58 draft GLP. Main proposed changes and their possible impact.
Grande, Alessandra; Merck Biopharma, Turin, Italy
14:00 - 16:00Session: Risk Management_1
Chair: Pillwein, Marion; Merck KGaA, Darmstadt, Germany
14:00 - 14:45ISO 9001:2015 within clinical trial management – an approach for risk based quality management
Schaaf, Stefan; Q-FINITY, Dillingen, Germany
14:45 - 15:30Practical Examples for Risk Management
König, Steffen; IST GmbH; Mannheim, Germany
15:30 - 16:00Break

16:00 - 17:30Session: Good Vigilance Practice_1
Chair: Scholz, Bianca; ScholzPharma GmbH, Bensheim, Germany
16:00 - 16:45E2B R3 Implementation and associated requirements
Alesik, Eva; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
16:45 - 17:30Risk Based Audit Program - the Art of Selecting the Right Targets.
Weber, Melanie; Pietrek Associates, Weinheim, Germany
14:00 - 16:00Session: Good Distribution Practice_1
Chair: Niggemann, Björn; ELPRO-BUCHS AG, Buchs, SG, Switzerland
14:00 - 14:45Just 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

14:45 - 15:30The last mile of drug supply in clinical trials
Behrend, Bardo; Nextpharma, Göttingen
15:30 - 16:00Break

16:00 - 17:30Session: Good Manufacturing Practice_1
Chair: Frankenberg, Nadine; synlab pharma institute AG , Birsfelden, Switzerland
16:00 - 16:45Finding the Path to Data Integrity in aGMP environment
Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany
Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany

16:45 - 17:30Continuation: Finding the Path to Data Integrity in aGMP environment
Hattwig, Volker; Coconeo Ltd., Düsseldorf, Germany
Hattwig, Bettina; Coconeo Ltd., Düsseldorf, Germany

Freitag, 22. September 2017
09:00 - 11:00Session: Good Laboratory Practice_2
Chair: Neuss, Jürgen; Bayer AG, Frankfurt, Germany
09:00 - 09:45Laboratories are going “Paperless”: Electronic Raw Data Archiving in practice
Schölzke, Brunhilde; Merck Sharpe & Dhome (MSD), Schwabenheim, Germany
09:45 - 10:30Is 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 - 11:00Break

11:00 - 12:30Session: Good Laboratory Practice_3
Chair: Schepers, Ulrich; BASF SE, Limburgerhof, Germany
11:00 - 11:45GLP 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 - 12:30GLP Round Table Discussion (continued)

09:00 - 11:00Session: Good Clinical Practice_1
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany

09:00 - 09:45Electronic Informed Consent
Stanbrook, Rebecca; Novartis, Basel, Switzerland
09:45 - 10:30Archiving of eClinical Systems and Data
Summa, Wolfgang; Merck, Darmstadt, Germany

10:30 - 11:00Break

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


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

12:30 - 14:00Lunch

14:00 - 15:00Plenary Session GxP_4
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany
14:00 - 14:45Patient Centricity: How to successfully involve patients into clinical development
Keiper, Tanja; Merck KGaA; Darmstadt, Germany
14:45 - 15:00Closing Remarks
König, Steffen; GQMA
15:00 - 15:15Short break

15:15 - 16:15GQMA Members' Meeting
Chairs: König, Steffen, GQMA
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