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Tagungen/Jahrestagung 2013

1. Europäische QA Konferenz und 18. Jahrestagung der DGGF



European QA Conference Website: EU Konferenz

Die 18. Jahrestagung 2013 und 1. Europäische QA Konferenz fand vom 25. bis 27. September 2013 im Maritim Hotel, Bonn statt.
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Der Download der Präsentationen endet Ende Februar 2014!

Programm Vorträge Referenten

Mittwoch, 25. September 2013
08:00 - 12:45Plenary Session
SAAL MARITIM
08:00Conference registration

09:00 - 09:15Opening address
DGGF - Steffen König
SoFAQ - Laurent Bouillot
RQA - Louise Handy

09:15 - 10:45Session 1 - KEYNOTE SPEAKER
Chairs: Steffen König, Laurent Bouillot and Louise Handy
09:15 - 10:15Risk Management - Lessons learnt from aviation
Müller, Manfred; Lufthansa
10:15 - 10:45Break

10:45 - 12:45Session 2
Chair: König Steffen; IST
10:45 - 11:45Changes in European Regulation
Sweeney, Fergus; EMA
11:45 - 12:45Risk-based quality management of clinical trials- What is special about the concept
Schwarz, Gabriele; BfARM
12:45 - 14:00Lunch

14:00 - 18:15Stream One - Outsourcing - Vendor Oversight
SAAL REGER
14:00 - 15:30Stream One - Outsourcing - Vendor Oversight - Session 3
Chair: Stevens, Nichola; Astra Zeneca

14:00 - 14:45How can effective oversight be implemented to improve vendor quality in clinical development?
Scaife, Richard; Mitsubishi Pharma Europe
14:45 - 15:30QA Aspects/challenges with outsourced manufacturing including impact of updated Chapter 7 of EU GMP, and the Falsified Medicines Act
Porter, Steve; AstraZeneca, UK
15:30 - 16:00Break

16:00 - 18:15Stream One - Outsourcing - Vendor Oversight - Session 4
Chair: Elliston, Jane; Battelle UK
16:00 - 16:45Outsourcing - A study in human behaviour
Brown, Colin, Charles River Laboratories
16:45 - 17:30A day in the life of a CRO: Everyday considerations for outsourcing GLP
Furrow, Greg; WIL Research
17:30 - 18:15Outsourcing challenges from a 'small' biotech perspective
Defert, Olivier; AMAKEN NV
14:00 - 17:30Stream Two - Risk Management
SAAL MARITIM
14:00 - 16:00Stream Two - Risk Management - Session 3
Chair: Liang, Catherine; Ricerca BioSciences
14:00 - 14:45Quality risk management, how does that impact QA workload?
Piton, Alain; Galderma R&D
14:45 - 15:30Risk - What happens if we get it wrong?
Horne, Barney; Novartis Pharma AG
15:30 - 16:00Break

16:00 - 17:30Stream Two - Risk Management - Session 4
Chair: König, Kerstin; Merck
16:00 - 16:45Risk - How does it fit across quality roles?
Widler, Beat; Widler and Schiemann Ltd
16:45 - 17:30Audit/quality strategies for GxP compliance
Ghent, Anne; Amgen Ltd
14:00 - 17:30Stream Three - Data Challenges
SAAL SCHUMANN
14:00 - 16:00Stream Three - Data Challenges - Session 3
Chair: Buot, Rose; Covance
14:00 - 14:45Data exchanging
Kranich, Sylvia; SK Consulting
14:45 - 15:30Digitalisation of documents in a GxP environment
Bursian, Michael; Grunenthal GmbH
15:30 - 16:00Break

16:00 - 17:30Stream Three - Data Challenges - Session 4
Chair: Davidson, Paul; ICON
16:00 - 16:45Can we destroy the paper?
Gittens, Gillian; Phlexglobal Ltd
16:45 - 17:30Quality and eTMF implementation
Thorley, Martin; Pfizer
18:15 - 19:15Meet the Delegate Drinks Reception

Donnerstag, 26. September 2013
09:00 - 17:15Stream A: Good Laboratory Practice
SAAL MARITIM
09:00 - 11:00Stream A: GLP - Session 1
Chair: Schepers, Ulrich; BASF SE, Crop Protection
09:00 - 09:45Hamonisation of Compliance Monitoring Authority expectations within OECD GLP community
Gray, Andrew; MHRA
09:45 - 10:30Organisation and procedures of Italian Monitoring Authority
Meneguz, Annarita; Italian National Public Health
10:30 - 11:00Break

11:00 - 13:45Stream A: GLP - Session 2
Chair: Schepers, Ulrich; BASF SE, Crop Protection
11:00 - 12:30GLP Round table discussion - Questions and answers
Gray, Andrew Gray; MHRA
Bulling, Wolf ; Federal Institute for Risk Assessment, Germany
Bauer, Ronald; Austrian Agency for Health and Food Safety, Austria
Meneguz, Annarita; National Public Health Institute, Italy
Abdon, Dominique; Safety and Pharmacovigilance Inspection Unit, France
Schepers, Ulrich Schepers; BASF

13:45 - 15:45Stream A: GLP - Session 3
Chair: Liang, Catherine; Ricerca BioSciences
13:45 - 14:30Multi-site studies - Who is really in control?
Davies, Peter; Peter Davies Associates
14:30 - 15:15GLP certification experience in China
Mutch, Marian; Covance
15:15 - 15:45Break

15:45 - 17:15Stream A: GLP - Session 4
Chair: Liang, Catherine; Ricerca BioSciences
15:45 - 16:30Analysis of clinical trial samples: What is important for a GLP laboratory according to the EMA reflection paper?
Fleischhauer, Ilona; Fraunhofer Institute for Toxicology and Experimental Medicine
16:30 - 17:15GLP Implementation at the University of Barcelona: The quality research service
Navarro Aragay, Carmen; Barcelona University
19:30PRE DINNER DRINKS RECEPTION followed by DINNER DANCE

09:00 - 17:15Stream B: Good Manufacturing Practice/Animal Health
SAAL KOCH
09:00 - 11:00Stream B: Session 1 - GMP
Chair: McAteer, Rhona; TMQA
09:00 - 09:45Risk-based inspections
Stanbrook, Rebecca; MHRA
09:45 - 10:30ANSM Inspection division activities and developments
Viornery, Lional; ANSM
10:30 - 11:00Break

11:00 - 13:45Stream B: Session 2 - GMP
Chair: Frankenberg, Nadine; Bureco AG
11:00 - 11:45Preparation, organisation and follow-up of FDA inspections/differences with EU inspections
Wiedner, Harald;QuasSyCon GmbH
11:45 - 12:30GDP: Gaps discovered and prioritised - a risk-based approach to the new EU GDP guidelines
Nadarajah, Sanjay; Inglasia Pharma Solutions
13:45 - 15:45Stream B: Session 3 - Animal Health
Chair: Murphy, Marci; Boehringer Ingelheim Animal Health GmbH
13:45 - 14:30Obtaining regulatory approval for clinical studies in Europe and requirements for clinical supplies management
Schneider, Claudia; Klifovet AG
14:30 - 15:15Monitoring multinational studies
Petersen, Ivo; MSD Animal Health Innovation GmbH
15:15 - 15:45Break

15:45 - 17:15Stream B: Session 4 - Animal Health
Chair: Murphy, Marci; Boehringer Ingelheim Animal Health GmbH
15:45 - 16:30Globalisation/harmonisation and its impact for sponsors
Harris, Gareth; Merck
16:30 - 17:15Help! What is EDC?
Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services
19:30PRE DINNER DRINKS RECEPTION followed by DINNER DANCE

09:00 - 17:15Stream C: Good Clinical Practice/Medical Devices/Non Commercial
SAAL SCHUMANN
09:00 - 11:00Stream C: Session 1 - GCP
Chair: Hartlieb-Wallthor-Sano Christiane
09:00 - 09:45Voluntary authorisation procedures and EU CT Regulation
Szalay, Gudrun; Paul-Ehrlich Institute
09:45 - 10:30MHRA GCP Guide: Applicable across Europe?
Wilsher, Colin; Consultant
10:30 - 11:00Break

11:00 - 13:45Stream C: Session 2 - GCP
Chair: Damour, Brigitte; Aptiv Solutions
11:00 - 11:45Introduction to strategic knowledge management
Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich
11:45 - 12:30Auditing in the digital age
Strickland, Paul; Strickland Quality Assurance Ltd
13:45 - 15:45Stream C: Session 3 - GCP/Medical Devices
Chair: Tillmann, Angelika; Theorem Clinical Research
13:45 - 14:30How secure are clinical data following ISO 14155?
Koehnen, Judith; Theorem Clinical Research GmbH & Co KG
14:30 - 15:15The EU Medical Devices Directive and the role of Notified Bodies
O'Donnell, Matthew; BSI Group
15:15 - 15:45Break

15:45 - 17:15Stream C: Session 4 - GCP/Non Commercial
Chair: Tillmann, Angelika; Theorem Clinical Research
15:45 - 16:30GCP, but not as we know it
Henley, Patricia; London School of Hygiene and Tropical Medicine
16:30 - 17:15Welcome to my planet: Non commercial research
Eldridge, Joy; University of Aberdeen/NHS Grampian
19:30PRE DINNER DRINKS RECEPTION followed by DINNER DANCE

09:00 - 17:15Stream D: Information Technology
SAAL REGER
09:00 - 11:00Stream D: Information Technology - Session 1
Chair: Morgenthaler, Helmuth; DGGF
09:00 - 09:45AGIT Guidance on change management - Compliant change management in a GLP regulated environment
Hassler, Stephan; Harlan Laboratories Ltd
09:45 - 10:30Vendor audit of an offshore IT development company - Process and experiences
Regehr, Michael; BASF Corporation
10:30 - 11:00Break

11:00 - 13:45Stream D: Information Technology - Session 2
Chair: Morgenthaler, Helmuth; DGGF
11:00 - 11:45Audit of IT services used pharma R&D - Technical challenges, regulatory expectations, audit concepts
Reddy, Manu; Bayer HealthCare Pharmaceuticals
11:45 - 12:30Application of principles of GLP - Principles to a business process driven SOA environment - Prerequisites, flexibility and efficiency in a heterogeneous IT landscape
Dalz, Reinhard; Ernst & Young GmbH Wirtschaftsprufungsgeesellschaft
13:45 - 15:45Stream D: Information Technology - Session 3
Chair: Stevens, Nichola; AstraZeneca
13:45 - 14:30Applying GAMP 5 to data in R&D - How to maintain data integrity within GCP Processes
Henrichmann, Frank; PAREXEL International GmbH
14:30 - 15:15Management of mobile devices in a GxP regulated environment - Security and date integrity considerations
Montgomery, Chris; Boehringer Ingelheim
15:15 - 15:45Break

15:45 - 17:15Stream D: Information Technology - Session 4
Chair: Stevens, Nichola, AstraZeneca
15:45 - 16:30Contracted IT services - Advantages and disadvantages for a GxP environment
Taylor, Karen; AstraZeneca
16:30 - 17:15Generation of user requirements specifications to establish a tailored GxP compliant LIMS for a typical bioanalytical CRO - Highlights and pitfalls
Kretzschmar, Timo; Pharm-analyt Labor GmbH
19:30PRE DINNER DRINKS RECEPTION followed by DINNER DANCE

09:00 - 17:15Stream E: Pharmacovigilance/Medical Devices
SAAL HAYDN
09:00 - 11:00Stream E: Session 1 - PV
Chair: Jack, Allison; GlaxoSmithKline
09:00 - 09:45Master file requirements, expectations from a regulatory perspective
Halle, Dianne; ANSM
09:45 - 10:30Implementing quality management systems
Wishart, Maria; GlaxoSmithKline
10:30 - 11:00Break

11:00 - 14:45Stream E: Session 2 - PV
Chair: Bones, Pam; Allergan Ltd
11:00 - 11:45Implementation of Good Pharmacovigilance Practices Guidelines Modules 1-1V - A CRO QA perspective
Powell, Helen; InVentiv Health Clinical
11:45 - 12:30The use of relational modelling as a tool to detect safety signals amongst patients' web posts
Sawyer, James; Prism Ideas Ltd
13:45 - 15:45Stream E: Session 3 - PV
Chair: Scholz, Bianca; Scholz Consulting
13:45 - 14:30Managing patient safety in the EU - One year of experience with the new PV legislation
Pietrek, Monika; Pietrek Associates GmbH
14:30 - 15:15European risk management systems
Becker Susanne; Spm2
15:15 - 15:45Break

15:45 - 17:15Stream E: Session 4 - Medical Devices
Chair: Scholz, Bianca; Scholz Consulting
15:45 - 16:30Differences in regulatory pathways for combination products and the impact thereof in pharmacovigilance
Koch, Henry; QIMP Management Systems Ltd
16:30 - 17:15Medical Device vigilance
Watt, Lindsay; GlaxoSmithKline
19:30PRE DINNER DRINKS RECEPTION followed by DINNER DANCE

Freitag, 27. September 2013
09:45 - 12:00Plenary Session
SAAL MARITIM
09:45 - 11:00Plenary Session 1 - EUROPE AND WHAT THE FUTURE HOLDS
Chairs: Steffen König, Laurent Bouillot and Louise Handy
09:45 - 10:30The future in Europe for big pharma and how regulations impact us everyday
Hamilton, Nigel; Sanofi
10:30 - 11:00Break

11:00 - 12:00Plenary Session 2 - CONFERENCE REVIEW AND SUMMARY
Chairs: Steffen König, Laurent Bouillot and Louise Handy
11:00 - 11:45Summary of the conference - What have we learned
Waddell, Andrew; TMQA
11:45 - 12:00Conference closing presentation
DGGF - Steffen König
SoFAQ - Laurent Bouillot
RQA - Louise Handy

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