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Meetings/Annual Meeting 2014

19th Annual Meeting of DGGF

Flyer & Online Registration available

The 19th International Meeting will take place on Thursday 18th and Friday 19st of September 2014 at the Maritim Hotel, Otto-von-Guericke-Str. 87, 39104 Magdeburg, Germany.

There will be simultaneous translation from German to English (and vice versa) in the GxP, GCP and GLP Sessions!

To se the current flyer please press on the flyer picture right. Online Registration is available by CSM
Exhibitor, sponsorship and advertising opportunities
To view all the opportunities available, please click here to open the Exhibitor Flyer.

To book your exhibitor space or any of the sponsorship/advertising opportunities please complete the registration form at the back of this pack and fax it to Congress & Seminar Management on +49 8142 54735.

For further questions please contact: abstracts@dggf.de

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Programme Titles Presenters

Wednesday, September 17, 2014
9:00 AM - 3:00 PMGLP-Preconference Training for Beginners
Die Teilnehmerzahl ist begrenzt!
Referent: Harston, Stephen, Honorary President, DGGF

Thursday, September 18, 2014
9:00 AM - 12:30 PMPlenary Session

8:00 AMConference registration

9:00 AM - 9:15 AMOpening address
König, Steffen, DGGF

9:15 AM - 11:00 AMPlenary Session 1 - KEYNOTE SPEAKER
Chairs: König, Steffen, DGGF
9:15 AM - 10:30 AMSecret Weapon: Communication
Martin, Leo
10:30 AM - 11:00 AMBreak

11:00 AM - 12:30 PMPlenary Session 2
Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany
11:00 AM - 11:45 AMQuality in Non-GxP Research
Bongiovanni, Sandrine; Novartis Pharma AG, Basel, Switzerland
11:45 AM - 12:30 PMTransCelerate – an Overview
Hugeneck, Katarina; Wien, Austria
12:30 PM - 2:00 PMLunch

2:00 PM - 5:30 PMStream One - Good Laboratory Practice
Chair: Schepers Ulrich; BASF SE, Limburgerhof, Germany
2:00 PM - 2:45 PMInspection Results from German Test Facilities
Gottschalk Marina; Bundesinstitut für Risikobewertung (BfR), Berlin, Germany

2:45 PM - 3:30 PMGLP Round Table Discussion Part 1 - Moderation Stephen Harston
Liem, Francisca; US EPA, Washington, USA
Gredilla, Elisa; ENAC, Madrid, Spain
Bulling, Wolf ; Federal Institute for Risk Assessment, Berlin, Germany
Bauer, Ronald; Austrian Agency for Health and Food Safety, Austria
Schepers, Ulrich; BASF SE, Limburgerhof, Germany

3:30 PM - 4:00 PMBreak

4:00 PM - 5:30 PMGLP Round Table Discussion Part 2 - Moderation Stephen Harston
Liem, Francisca; US EPA, Washington, USA
Gredilla, Elisa; ENAC, Madrid, Spain
Bulling, Wolf ; Federal Institute for Risk Assessment, Berlin, Germany
Bauer, Ronald; Austrian Agency for Health and Food Safety, Austria
Schepers, Ulrich; BASF SE, Limburgerhof, Germany

2:00 PM - 5:30 PMStream Two - Good Clinical Practice

2:00 PM - 4:00 PMStream Two - Good Clinical Practice - Session I
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany
2:00 PM - 2:30 PMTargeted/risk-based approaches in trial execution: opportunities and challenges
Vogelgesang, Sven; Merck KGaA, Darmstadt, Germany
2:30 PM - 3:00 PMTransCelerate – Risk-Based Monitoring – The Approach
Van de Voorde, Kristel; Bristol-Myers Squibb International Corporation, Braine-l’Alleud, Belgium
3:00 PM - 3:30 PMInspection Readiness – Give Yourself the Best Chance
Strickland, Paul; Strickland Quality Assurance Ltd, St Ives, UK
3:30 PM - 4:00 PMBreak

4:00 PM - 5:30 PMStream Two - Good Clinical Practice - Session II
Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany
4:00 PM - 4:30 PMGCP Inspections in Laboratories
Mettke, Katalina; BfArM, Bonn, Germany
4:30 PM - 5:00 PMGood Clinical Practice – Implementation in bioanalytics of clinical samples
Ruhfus, Birgit; Bayer Pharma, Berlin, Germany
5:00 PM - 5:30 PMGood Distribution Practice and Regulatory Compliance In International Biopharm Logistics
Fleischer, Michael; World Courier, Hamburg, Germany
2:00 PM - 5:30 PMStream Three - Good Manufacturing Practice
Chair: Frankenberg, Nadine; Bureco AG, Reinach, Switzerland
2:00 PM - 2:45 PMImport of active substances and medicinal products – an update
Wanninger, Gabriele; Regierung von Oberbayern, München, Germany
2:45 PM - 3:30 PMOutsourcing – Responsibility of the Qualified Person (QP)
Pahlen, Bettina; Quality x Pharma Consulting, Alling, Germany
3:30 PM - 4:00 PMBreak

4:00 PM - 4:45 PMGood Meditation Practice:The Importance Of Silence On Quality Relevant Decisions
Schad, Christian; IS+S Informationstechnik GmbH, Aschaffenburg, Germany
4:45 PM - 5:30 PMRound Table Discussion
Wanninger, Gabriele; Regierung von Oberbayern, München
Pahlen, Bettina; Quality x Pharma Consulting, Alling
Schad, Christian; IS+S Informationstechnik GmbH, Aschaffenburg

Friday, September 19, 2014
9:00 AM - 12:30 PMStream A: Good Laboratory Practice

9:00 AM - 11:00 AMStream A: Good Laboratory Practice - Session 1
Chair: Neuss, Jürgen; Bayer CropScience, Frankfurt, Germany;
Morgenthaler, Helmuth; Ludwigshafen, Germany

9:00 AM - 9:45 AMThe US EPA Good Laboratory Practice Program in 2013
Liem, Francisca; US Environmental Protection Agency (EPA), USA
9:45 AM - 10:30 AMThe status of the draft OECD GLP advisory document “The Application of GLP Principles to Computerized Systems”
Bauer, Ronald; Austrian Agency for Health and Food, Austria
10:30 AM - 11:00 AMBreak

11:00 AM - 12:30 PMStream A: Good Laboratory Practice - Session 2
Chair: Neuss, Jürgen; Bayer CropScience, Frankfurt, Germany;
Hermann, Frauke; Harlan, Roßdorf, Germany

11:00 AM - 11:30 AMPathology Peer Review - What extent of regulation is needed?
Uhde, Holger; Sanofi-Aventis, Frankfurt, Germany

11:30 AM - 12:00 PMThe Spanish GLP Monitoring System for pesticide and chemical studies
Gredilla, Elisa; Entidad Nacional de Acreditación (ENAC), Madrid, Spain

12:00 PM - 12:30 PMExperiences in harmonization of QA programs of a CRO based in different European countries - Monitoring authority requirements and client expectations
Carrera, Àngels Jiménez; CRS Harlan Laboratories, Santa Perpetua de la Mogoda, Spain

9:00 AM - 12:30 PMStream B: GVP/GCP

9:00 AM - 11:00 AMStream B: GVP/GCP - Session I
Chair: Stelzer, Günther; CQC, Freiburg, Germany
9:00 AM - 9:30 AMNew EU Regulation on "Clinical trials" - an industry perspective
Ruppert, Thorsten; VFA e.V., Berlin, Germany
9:30 AM - 10:00 AMThe new EU regulation for clinical trials – an Ethics Committee’s perspective
Hasford, Jörg; AK Medizinischer Ethikkommissionen in der BRD e.V., Gräfelfing, Germany
10:00 AM - 10:30 AMUpdates on EU Regulation and GVP modules
Scholz, Bianca; Scholz Consulting, Bensheim

10:30 AM - 11:00 AMBreak

11:00 AM - 12:30 PMStream B: GVP/GCP - Session II
Chair: Scholz, Bianca; Scholz Consulting, Bensheim

11:00 AM - 11:45 AMPharmacovigilance in PASS, PAES and NIS
Kienzle-Horn, Susanne; SCRATCH PV GmbH, Butzbach, Gernany

11:45 AM - 12:30 PMOverview – PRAC and the implications for the pharmaceutical industry
Thurisch, Boris; BPI e.V., Berlin, Germany

9:00 AM - 12:30 PMStream C: Analytics / Information Technology

9:00 AM - 11:00 AMStream C: Analytics / Information Technology - Analytic Session
Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany
9:00 AM - 9:30 AMValidation of methods for biomarker analysis in clinical trials: regulatory requirements and challenges
Wnendt, Stephan; MLM Medical Labs, Mönchengladbach, Germany
9:30 AM - 10:00 AMDocumentation on Sample Preparation for Analysis – How Deep is Necessary and How Deep is Meaningful? Is there Rising a New Area of Conflicts between Laboratory and Authority?
Kretzschmar, Timo; pharm-analyt Labor GmbH, Baden, Austria
10:00 AM - 10:30 AMStrategies for Long-Term Retention of Laboratory Data
Schäfer, Burkhard; BSSN Software

10:30 AM - 11:00 AMBreak

11:00 AM - 12:30 PMStream C: Information Technology - IT Session
Chair: Morgenthaler, Helmuth; Ludwigshafen, Germany
11:00 AM - 11:45 AMA Risk-Based Approach to IT-Vendor Management at Bayer Health Care
Stoll, Olga; Bayer Consumer Care AG, Basel, Switzerland

11:45 AM - 12:30 PMIssues of file-based acquisition systems using Windows operating systems and its impact on validation
Schmidt, Ronald; Sanofi-Aventis, Frankfurt, Germany

12:30 PM - 2:00 PMLunch

2:00 PM - 3:45 PMPlenary Session
Chairs: König Steffen; DGGF
2:00 PM - 2:45 PMLessons Learned: Would you rather avoid failure or seek success?
Kammerer, Petra; Kompetenz in der Klifo-Praxis, Berlin, Germany
2:45 PM - 3:00 PMClosing Remarks
König, Steffen; DGGF
3:00 PM - 3:15 PMBreak

3:15 PM - 4:15 PMDGGF Members' Meeting
Chairs: König, Steffen, DGGF
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