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Tagungen/Jahrestagung 2014

19. Jahrestagung der DGGF

Flyer & Online Anmeldung verfügbar
Die Jahrestagung 2014 findet vom 18. bis 19. September 2014 im Maritim Hotel, Otto-von-Guericke-Str. 87, 39104 Magdeburg statt. Wie immer, wird eine „Einführung in der GLP“ am Vortag
(17. September 2014) angeboten.

In den GxP, GCP and GLP Sessions wird eine Simultanübersetzung von Englisch zu Deutsch und vice versa angeboten.

Der Tagungsflyer ist nun verfügbar - bitte klicken Sie rechts auf das Flyerbild. Die Online-Anmeldung steht bei unserer Veranstaltungsagentur CSM zur Verfügung: Anmeldung.
Exhibitor, sponsorship and advertising opportunities
Um alle Möglichkeiten für Aussteller, Sponsoren und Werbeaktionen ansehen zu können, klicken Sie bitte hier, um den Exhibition Flyer zu öffnen.

Um Ausstellungsflächen zu buchen, verwenden Sie das Formblatt im Flyer und faxen oder mailen es an das Congress & Seminar Management..

Sollten Sie Fragen haben oder weitere Informationen benötigen, stehen wir Ihnen unter der Adresse
abstracts@dggf.de gerne zur Verfügung.



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Programm Vorträge Referenten

Mittwoch, 17. September 2014
09:00 - 15:00GLP-Preconference Training für Einsteiger
Die Teilnehmerzahl ist begrenzt!
Referent: Harston, Stephen, Honorary President, DGGF

Donnerstag, 18. September 2014
09:00 - 12:30Plenary Session

08:00Conference registration

09:00 - 09:15Opening address
König, Steffen, DGGF

09:15 - 11:00Plenary Session 1 - KEYNOTE SPEAKER
Chairs: König, Steffen, DGGF
09:15 - 10:30Secret Weapon: Communication
Martin, Leo
10:30 - 11:00Break

11:00 - 12:30Plenary Session 2
Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany
11:00 - 11:45Quality in Non-GxP Research
Bongiovanni, Sandrine; Novartis Pharma AG, Basel, Switzerland
11:45 - 12:30TransCelerate – an Overview
Hugeneck, Katarina; Wien, Austria
12:30 - 14:00Lunch

14:00 - 17:30Stream One - Good Laboratory Practice
Chair: Schepers Ulrich; BASF SE, Limburgerhof, Germany
14:00 - 14:45Inspection Results from German Test Facilities
Gottschalk Marina; Bundesinstitut für Risikobewertung (BfR), Berlin, Germany

14:45 - 15:30GLP 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

15:30 - 16:00Break

16:00 - 17:30GLP 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

14:00 - 17:30Stream Two - Good Clinical Practice

14:00 - 16:00Stream Two - Good Clinical Practice - Session I
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany
14:00 - 14:30Targeted/risk-based approaches in trial execution: opportunities and challenges
Vogelgesang, Sven; Merck KGaA, Darmstadt, Germany
14:30 - 15:00TransCelerate – Risk-Based Monitoring – The Approach
Van de Voorde, Kristel; Bristol-Myers Squibb International Corporation, Braine-l’Alleud, Belgium
15:00 - 15:30Inspection Readiness – Give Yourself the Best Chance
Strickland, Paul; Strickland Quality Assurance Ltd, St Ives, UK
15:30 - 16:00Break

16:00 - 17:30Stream Two - Good Clinical Practice - Session II
Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany
16:00 - 16:30GCP Inspections in Laboratories
Mettke, Katalina; BfArM, Bonn, Germany
16:30 - 17:00Good Clinical Practice – Implementation in bioanalytics of clinical samples
Ruhfus, Birgit; Bayer Pharma, Berlin, Germany
17:00 - 17:30Good Distribution Practice and Regulatory Compliance In International Biopharm Logistics
Fleischer, Michael; World Courier, Hamburg, Germany
14:00 - 17:30Stream Three - Good Manufacturing Practice
Chair: Frankenberg, Nadine; Bureco AG, Reinach, Switzerland
14:00 - 14:45Import of active substances and medicinal products – an update
Wanninger, Gabriele; Regierung von Oberbayern, München, Germany
14:45 - 15:30Outsourcing – Responsibility of the Qualified Person (QP)
Pahlen, Bettina; Quality x Pharma Consulting, Alling, Germany
15:30 - 16:00Break

16:00 - 16:45Good Meditation Practice:The Importance Of Silence On Quality Relevant Decisions
Schad, Christian; IS+S Informationstechnik GmbH, Aschaffenburg, Germany
16:45 - 17:30Round Table Discussion
Wanninger, Gabriele; Regierung von Oberbayern, München
Pahlen, Bettina; Quality x Pharma Consulting, Alling
Schad, Christian; IS+S Informationstechnik GmbH, Aschaffenburg

Freitag, 19. September 2014
09:00 - 12:30Stream A: Good Laboratory Practice

09:00 - 11:00Stream A: Good Laboratory Practice - Session 1
Chair: Neuss, Jürgen; Bayer CropScience, Frankfurt, Germany;
Morgenthaler, Helmuth; Ludwigshafen, Germany

09:00 - 09:45The US EPA Good Laboratory Practice Program in 2013
Liem, Francisca; US Environmental Protection Agency (EPA), USA
09:45 - 10:30The 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 - 11:00Break

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

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

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

12:00 - 12:30Experiences 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

09:00 - 12:30Stream B: GVP/GCP

09:00 - 11:00Stream B: GVP/GCP - Session I
Chair: Stelzer, Günther; CQC, Freiburg, Germany
09:00 - 09:30New EU Regulation on "Clinical trials" - an industry perspective
Ruppert, Thorsten; VFA e.V., Berlin, Germany
09:30 - 10:00The 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 - 10:30Updates on EU Regulation and GVP modules
Scholz, Bianca; Scholz Consulting, Bensheim

10:30 - 11:00Break

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

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

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

09:00 - 12:30Stream C: Analytics / Information Technology

09:00 - 11:00Stream C: Analytics / Information Technology - Analytic Session
Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany
09:00 - 09:30Validation of methods for biomarker analysis in clinical trials: regulatory requirements and challenges
Wnendt, Stephan; MLM Medical Labs, Mönchengladbach, Germany
09:30 - 10:00Documentation 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 - 10:30Strategies for Long-Term Retention of Laboratory Data
Schäfer, Burkhard; BSSN Software

10:30 - 11:00Break

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

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

12:30 - 14:00Lunch

14:00 - 15:45Plenary Session
Chairs: König Steffen; DGGF
14:00 - 14:45Lessons Learned: Would you rather avoid failure or seek success?
Kammerer, Petra; Kompetenz in der Klifo-Praxis, Berlin, Germany
14:45 - 15:00Closing Remarks
König, Steffen; DGGF
15:00 - 15:15Break

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