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Tagungen/Jahrestagung 2018

23. Jahrestagung der DGGF

Flyer & Online Anmeldung verfügbar

Die 23. Jahrestagung 2018 findet vom 20. bis 21. September 2018 im Maritim Hotel, Bonn statt.

Der Tagungsflyer ist nun verfügbar - bitte klicken Sie hier (Tagungsflyer) oder rechts auf das Flyerbild.

Informationen für Aussteller, Sponsoren und für Werbeaktionen finden Sie im aktuellen Tagungsflyer.

Zum Anmelden können Sie direkt zu unserem Konferenzveranstalter gehen: CSM

Auch dieses Jahr finden am Vortag, dem 19.09.2018, wieder Pre-conference trainings statt:

Kommunikations-Strategien im Audit

Auditor in der Pharmakovigilanz

GLP Basistraining



Programm Vorträge Referenten

Mittwoch, 19. September 2018
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

09:00 - 17:30Auditor in der Pharmacovigilianz
Scholz, Bianca; Scholzpharma GmbH, Germany
18:00Conference registration

Donnerstag, 20. September 2018
09:00 - 11:00Plenary Session GxP_1
Chairs: König, Steffen; GQMA, Berlin, Germany
09:00 - 09:15Opening address
König, Steffen, GQMA President

09:15 - 10:30A Decentralized World: Why the Future of Quality Assurance Lies in the Hands of the Public (E)
Tzezana, Roey; Blavatnik Interdisciplinary Cyber Research Center (BICRC), Tel Aviv, Israel
10:30 - 11:00Networking Coffee Break

11:00 - 12:30Session IT_1 - Information Technology
Chair: Caparros, Daniel; Merck KGaA, Darmstadt, Germany
11:00 - 11:45Fit for Future? - Cloud Computing and Validation (D)
Baumann, Ingo; Thescon GmbH, Coesfeld, Germany
11:45 - 12:30GXP System Validation in the Era of Big Data (D)
Riedel, Sebastian; Merck KGaA, Darmstadt, Germany
11:00 - 12:30Session GCP_1 - Regulations
Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany
11:00 - 11:45General Data Protection Regulation In Force – Key Implementation Challenges (D)
Westphal, Vanessa; Merck KGaA, Darmstadt, Germany
11:45 - 12:30Radiation protection in clinical trials - improvements in Germany in sight? (D)
Ruppert, Thorsten;, vfa, Berlin, Germany
11:00 - 12:30Session PV_1
Chair: Scholz, Bianca; ScholzPharma GmbH, Bensheim, Germany
11:00 - 11:45News from PRAC - Hot Topics PV (D)
Huber, Martin; BfArM, Bonn, Germany
11:00 - 11:45n.n.
n.n.
12:30 - 14:00Lunch

14:00 - 16:00Session: GLP_1
Chair: Henrichs, Andreas; Sanofi-Aventis, Frankfurt, Germany
14:00 - 14:45The Swedish GLP System (E)
Svensson, Sophie; SWEDAC, Stockholm, Sweden
14:45 - 15:30The Implementation of OECD Document No. 17 in Switzerland (D)
Klenke, Elisabeth; Swissmedic, Bern, Switzerland
15:30 - 16:00Networking Coffee Break

16:00 - 17:45Session: GLP_2 - Round Table Discussion (D/E)
Chair: Schepers, Ulrich; BASF SE, Limburgerhof, Germany
16:00 - 17:30GLP Round Table Discussion (D/E)
Bulling, Wolf; BfR, GLP Federal Bureau, Berlin, Germany
Klenke, Elisabeth; Swissmedic, Bern, Switzerland
Svensson, Sophie; SWEDAC, Stockholm, Sweden
Jacobi, Tobias; Ministry of the Environment, Energy, Nutrition and Forestry, Mainz, Germany
Uhde, Holger; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany

14:00 - 16:00Session: GCP_2 - Auditing
Chair: König, Kerstin; Merck KGaA, Darmstadt, Germany
14:00 - 14:45Auditing 4.0 - Auditing in a future scenario (D)
Mihaescu, Florinda; AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
14:45 - 15:30Audits of GxP Computerized Systems (D)
Pflug, Simon; Bayer AG, Wuppertal, Germany
15:30 - 16:00Networking Coffee Break

16:00 - 17:30Session: IT_2
Chair: Caparros, Daniel; Merck KGaA, Darmstadt, Germany
16:00 - 16:30Increasing Quality Through Agile SW Development Methods (D)
Münch, Stefan; Systec & Services GmbH, Karlsruhe, Germany
16:30 - 17:00Improve Patient Support Programs delivery by harmonization and standardization of processes and data (D)
Strohmaier, Antje; Merck KGaA, Darmstadt, Germany
Lein, Ulrich; MAIN5, Frankfurt am Main, Germany

17:00 - 17:30Global Labeling Document Management System: Lessons learned and best practices (D)
Schneider, Sabine; Fresenius Kabi, Oberursel, Germany
Krüger, Karsten; MAIN5, Frankfurt am Main, Germany

14:00 - 16:00Session: PV_2
Chair: Scholz, Bianca; ScholzPharma GmbH, Bensheim, Germany
14:00 - 14:45Authority`s View - eRMR (D)
n.n., Germany
14:45 - 15:30PV Round Table Discussion (D)
Huber, Martin; BfArM, Bonn, Germany
15:30 - 16:00Networking Coffee Break

16:00 - 17:30Session: Good Manufacturing Practice_1
Chair: Frankenberg, Nadine; synlab pharma institute AG , Birsfelden, Switzerland
16:00 - 16:45n.n.
Menne, Thomas; Firma, Ort, Land
16:45 - 17:30GMPs for ATMPs. GMP light for new Therapies? (D)
Brett, Raimund; Chemgineering AG, Münchenstein, Switzerland
Freitag, 21. September 2018
09:00 - 11:00Session: Good Laboratory Practice_3
Chair: Neuss, Jürgen; Bayer AG, Frankfurt, Germany
09:00 - 09:45„OECD Advisory Document No. 19 - Management, Characterisation and Use of Test Items“ – a supportive guidance? (D)
Veit, Uwe; Eurofins Agroscience Services Ecotox GmbH, Niefern-Öschelbronn, Germany
09:45 - 10:30Hacking protected Excel spreadsheets within seconds (D)
Schmidt, Ronald; Sanofi-Aventis Deutschland, Frankfurt, Germany
10:30 - 11:00Networking Coffee Break

11:00 - 12:30Session: Good Laboratory Practice_4
Chair: Herrmann, Frauke; Envigo CRS GmbH, Rossdorf, Germany
11:00 - 11:45SEND introduction and experiences at Bayer (D)
Malkowski, Andrea; Bayer AG, Wuppertal, Germany

11:45 - 12:30Digital transformation – Development of a validated scanning process and its first experience (D)
Schramm, Anne; RHENUS Archiv Services, Berlin, Germany
09:00 - 11:00Session: QMS_1
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany
09:00 - 09:45Electronic Informed Consent Forms (eICF) in Global Clinical Trials (D)
Summa, Wolfgang; Merck KGaA, Darmstadt, Germany
09:45 - 10:30Sponsor Oversight of Service Providers: The Inspector`s Perspective (D)
Mettke, Katalina; BfArM, Bonn, Germany
10:30 - 11:00Networking Coffee Break

11:00 - 12:30Session: QMS_2
Chair: Pillwein, Marion; Merck KGaA, Darmstadt, Germany
11:00 - 11:45Risk-based Monitoring - Points to Consider in GCP Audits & Inspections (D)
Schwarz, Gabriele; BfArM, Bonn, Germany

11:45 - 12:30Data Integrity – A practical approach for implementation in GCP Area (D)
Busch-Heidger, Barbara; Boehringer Ingelheim Pharma, Biberach an der Riß, Germany
09:00 - 11:00Session: GDP_1
Chair: Niggemann, Björn; ELPRO-BUCHS AG, Buchs, SG, Switzerland
09:00 - 09:45GDP Supervision in Germany (D)
Schulze, Rico; Landesdirektion Sachsen, Chemnitz, Germany
09:45 - 10:30Data integrity in a GDP environment (D)
Dietz, Thomas; ELPRO-BUCHS AG, Buchs SG, Switzerland
10:30 - 11:00Networking Coffee Break

11:00 - 12:30Session GMP_GDP_2 - Round Table Discussion (D)
Chair: Niggemann, Björn; ELPRO-BUCHS AG, Buchs, SG, Switzerland
11:00 - 12:30GMP/GDP Round Table Discussion (D)
Brett, Raimund; Chemgineering AG, Münchenstein, Switzerland
Dietz, Thomas; ELPRO-BUCHS AG, Buchs SG, Switzerland
Menne, Thomas; Firma, Ort, Land
Landwehr, Josef; PTS Training Services, Leverkusen, Germany
Schulze, Rico; Landesdirektion Sachsen, Chemnitz, Germany

09:00 - 11:00Session: MD_1
Chair: Hahn, Markus; ARTIMED Medical Consulting GmbH, Kassel, Germany
09:00 - 09:45Impact of the MDR on the Clinical Data Requirements in Europe (D)
Akra, Bassil; TÜV Süd, München, Germany
09:45 - 10:30Impact of the MDR on Clinical Investigations - Perspective of the German Federal Authority (D)
Schriever, Ulf; BfArM, Bonn, Germany
10:30 - 11:00Networking Coffee Break

11:00 - 12:30Session: MD_2
Chair: Hahn, Markus; ARTIMED Medical Consulting GmbH, Kassel, Germany
11:00 - 11:45The appropriate clinical evaluation: Changes by the MDR? (D)
Prestel, Roland; Aesculap AG, Tuttlingen, Germany

11:45 - 12:30MP Round Table Discussion (D)
Akra, Bassil; TÜV Süd, München, Germany
Prestel, Roland; Aesculap AG, Tuttlingen, Germany
Schriever, Ulf; BfArM, Bonn, Germany

12:30 - 13:30Lunch

13:30 - 15:00Plenary Session GxP_2
Chair: Hartlieb-Wallthor-Sano, Christiane; Pro-TS, Monheim, Germany
13:30 - 14:15Pseudo-Quality: How we fool ourselves every day (D)
Rath, Ingo; CLiPS, Münster, Germany
14:15 - 15:00Quality and Soft Skills (Quality Culture) (D)
Landwehr, Josef; PTS Training Services, Leverkusen, Germany
15:00 - 15:15Closing Remarks

15:15 - 15:30Short Break

15:30 - 16:30GQMA Members' Meeting
Chairs: König, Steffen, GQMA
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