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Meetings/Annual Meeting 2013

1st European QA Conference and 18th Annual Meeting of DGGF



European QA Conference website: EU QA conference


The 18th International Meeting and 1st European QA Conference took place September 25th - 27th, Maritim Hotel, Bonn, Germany
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Download of presentation will be possible till end of February 2014!

Programme Titles Presenters

Wednesday, September 25, 2013
8:00 AM - 12:45 PMPlenary Session
SAAL MARITIM
8:00 AMConference registration

9:00 AM - 9:15 AMOpening address
DGGF - Steffen König
SoFAQ - Laurent Bouillot
RQA - Louise Handy

9:15 AM - 10:45 AMSession 1 - KEYNOTE SPEAKER
Chairs: Steffen König, Laurent Bouillot and Louise Handy
9:15 AM - 10:15 AMRisk Management - Lessons learnt from aviation
Müller, Manfred; Lufthansa
10:15 AM - 10:45 AMBreak

10:45 AM - 12:45 PMSession 2
Chair: König Steffen; IST
10:45 AM - 11:45 AMChanges in European Regulation
Sweeney, Fergus; EMA
11:45 AM - 12:45 PMRisk-based quality management of clinical trials- What is special about the concept
Schwarz, Gabriele; BfARM
12:45 PM - 2:00 PMLunch

2:00 PM - 6:15 PMStream One - Outsourcing - Vendor Oversight
SAAL REGER
2:00 PM - 3:30 PMStream One - Outsourcing - Vendor Oversight - Session 3
Chair: Stevens, Nichola; Astra Zeneca

2:00 PM - 2:45 PMHow can effective oversight be implemented to improve vendor quality in clinical development?
Scaife, Richard; Mitsubishi Pharma Europe
2:45 PM - 3:30 PMQA Aspects/challenges with outsourced manufacturing including impact of updated Chapter 7 of EU GMP, and the Falsified Medicines Act
Porter, Steve; AstraZeneca, UK
3:30 PM - 4:00 PMBreak

4:00 PM - 6:15 PMStream One - Outsourcing - Vendor Oversight - Session 4
Chair: Elliston, Jane; Battelle UK
4:00 PM - 4:45 PMOutsourcing - A study in human behaviour
Brown, Colin, Charles River Laboratories
4:45 PM - 5:30 PMA day in the life of a CRO: Everyday considerations for outsourcing GLP
Furrow, Greg; WIL Research
5:30 PM - 6:15 PMOutsourcing challenges from a 'small' biotech perspective
Defert, Olivier; AMAKEN NV
2:00 PM - 5:30 PMStream Two - Risk Management
SAAL MARITIM
2:00 PM - 4:00 PMStream Two - Risk Management - Session 3
Chair: Liang, Catherine; Ricerca BioSciences
2:00 PM - 2:45 PMQuality risk management, how does that impact QA workload?
Piton, Alain; Galderma R&D
2:45 PM - 3:30 PMRisk - What happens if we get it wrong?
Horne, Barney; Novartis Pharma AG
3:30 PM - 4:00 PMBreak

4:00 PM - 5:30 PMStream Two - Risk Management - Session 4
Chair: König, Kerstin; Merck
4:00 PM - 4:45 PMRisk - How does it fit across quality roles?
Widler, Beat; Widler and Schiemann Ltd
4:45 PM - 5:30 PMAudit/quality strategies for GxP compliance
Ghent, Anne; Amgen Ltd
2:00 PM - 5:30 PMStream Three - Data Challenges
SAAL SCHUMANN
2:00 PM - 4:00 PMStream Three - Data Challenges - Session 3
Chair: Buot, Rose; Covance
2:00 PM - 2:45 PMData exchanging
Kranich, Sylvia; SK Consulting
2:45 PM - 3:30 PMDigitalisation of documents in a GxP environment
Bursian, Michael; Grunenthal GmbH
3:30 PM - 4:00 PMBreak

4:00 PM - 5:30 PMStream Three - Data Challenges - Session 4
Chair: Davidson, Paul; ICON
4:00 PM - 4:45 PMCan we destroy the paper?
Gittens, Gillian; Phlexglobal Ltd
4:45 PM - 5:30 PMQuality and eTMF implementation
Thorley, Martin; Pfizer
6:15 PM - 7:15 PMMeet the Delegate Drinks Reception

Thursday, September 26, 2013
9:00 AM - 5:15 PMStream A: Good Laboratory Practice
SAAL MARITIM
9:00 AM - 11:00 AMStream A: GLP - Session 1
Chair: Schepers, Ulrich; BASF SE, Crop Protection
9:00 AM - 9:45 AMHamonisation of Compliance Monitoring Authority expectations within OECD GLP community
Gray, Andrew; MHRA
9:45 AM - 10:30 AMOrganisation and procedures of Italian Monitoring Authority
Meneguz, Annarita; Italian National Public Health
10:30 AM - 11:00 AMBreak

11:00 AM - 1:45 PMStream A: GLP - Session 2
Chair: Schepers, Ulrich; BASF SE, Crop Protection
11:00 AM - 12:30 PMGLP 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

1:45 PM - 3:45 PMStream A: GLP - Session 3
Chair: Liang, Catherine; Ricerca BioSciences
1:45 PM - 2:30 PMMulti-site studies - Who is really in control?
Davies, Peter; Peter Davies Associates
2:30 PM - 3:15 PMGLP certification experience in China
Mutch, Marian; Covance
3:15 PM - 3:45 PMBreak

3:45 PM - 5:15 PMStream A: GLP - Session 4
Chair: Liang, Catherine; Ricerca BioSciences
3:45 PM - 4:30 PMAnalysis 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
4:30 PM - 5:15 PMGLP Implementation at the University of Barcelona: The quality research service
Navarro Aragay, Carmen; Barcelona University
7:30 PMPRE DINNER DRINKS RECEPTION followed by DINNER DANCE

9:00 AM - 5:15 PMStream B: Good Manufacturing Practice/Animal Health
SAAL KOCH
9:00 AM - 11:00 AMStream B: Session 1 - GMP
Chair: McAteer, Rhona; TMQA
9:00 AM - 9:45 AMRisk-based inspections
Stanbrook, Rebecca; MHRA
9:45 AM - 10:30 AMANSM Inspection division activities and developments
Viornery, Lional; ANSM
10:30 AM - 11:00 AMBreak

11:00 AM - 1:45 PMStream B: Session 2 - GMP
Chair: Frankenberg, Nadine; Bureco AG
11:00 AM - 11:45 AMPreparation, organisation and follow-up of FDA inspections/differences with EU inspections
Wiedner, Harald;QuasSyCon GmbH
11:45 AM - 12:30 PMGDP: Gaps discovered and prioritised - a risk-based approach to the new EU GDP guidelines
Nadarajah, Sanjay; Inglasia Pharma Solutions
1:45 PM - 3:45 PMStream B: Session 3 - Animal Health
Chair: Murphy, Marci; Boehringer Ingelheim Animal Health GmbH
1:45 PM - 2:30 PMObtaining regulatory approval for clinical studies in Europe and requirements for clinical supplies management
Schneider, Claudia; Klifovet AG
2:30 PM - 3:15 PMMonitoring multinational studies
Petersen, Ivo; MSD Animal Health Innovation GmbH
3:15 PM - 3:45 PMBreak

3:45 PM - 5:15 PMStream B: Session 4 - Animal Health
Chair: Murphy, Marci; Boehringer Ingelheim Animal Health GmbH
3:45 PM - 4:30 PMGlobalisation/harmonisation and its impact for sponsors
Harris, Gareth; Merck
4:30 PM - 5:15 PMHelp! What is EDC?
Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services
7:30 PMPRE DINNER DRINKS RECEPTION followed by DINNER DANCE

9:00 AM - 5:15 PMStream C: Good Clinical Practice/Medical Devices/Non Commercial
SAAL SCHUMANN
9:00 AM - 11:00 AMStream C: Session 1 - GCP
Chair: Hartlieb-Wallthor-Sano Christiane
9:00 AM - 9:45 AMVoluntary authorisation procedures and EU CT Regulation
Szalay, Gudrun; Paul-Ehrlich Institute
9:45 AM - 10:30 AMMHRA GCP Guide: Applicable across Europe?
Wilsher, Colin; Consultant
10:30 AM - 11:00 AMBreak

11:00 AM - 1:45 PMStream C: Session 2 - GCP
Chair: Damour, Brigitte; Aptiv Solutions
11:00 AM - 11:45 AMIntroduction to strategic knowledge management
Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich
11:45 AM - 12:30 PMAuditing in the digital age
Strickland, Paul; Strickland Quality Assurance Ltd
1:45 PM - 3:45 PMStream C: Session 3 - GCP/Medical Devices
Chair: Tillmann, Angelika; Theorem Clinical Research
1:45 PM - 2:30 PMHow secure are clinical data following ISO 14155?
Koehnen, Judith; Theorem Clinical Research GmbH & Co KG
2:30 PM - 3:15 PMThe EU Medical Devices Directive and the role of Notified Bodies
O'Donnell, Matthew; BSI Group
3:15 PM - 3:45 PMBreak

3:45 PM - 5:15 PMStream C: Session 4 - GCP/Non Commercial
Chair: Tillmann, Angelika; Theorem Clinical Research
3:45 PM - 4:30 PMGCP, but not as we know it
Henley, Patricia; London School of Hygiene and Tropical Medicine
4:30 PM - 5:15 PMWelcome to my planet: Non commercial research
Eldridge, Joy; University of Aberdeen/NHS Grampian
7:30 PMPRE DINNER DRINKS RECEPTION followed by DINNER DANCE

9:00 AM - 5:15 PMStream D: Information Technology
SAAL REGER
9:00 AM - 11:00 AMStream D: Information Technology - Session 1
Chair: Morgenthaler, Helmuth; DGGF
9:00 AM - 9:45 AMAGIT Guidance on change management - Compliant change management in a GLP regulated environment
Hassler, Stephan; Harlan Laboratories Ltd
9:45 AM - 10:30 AMVendor audit of an offshore IT development company - Process and experiences
Regehr, Michael; BASF Corporation
10:30 AM - 11:00 AMBreak

11:00 AM - 1:45 PMStream D: Information Technology - Session 2
Chair: Morgenthaler, Helmuth; DGGF
11:00 AM - 11:45 AMAudit of IT services used pharma R&D - Technical challenges, regulatory expectations, audit concepts
Reddy, Manu; Bayer HealthCare Pharmaceuticals
11:45 AM - 12:30 PMApplication 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
1:45 PM - 3:45 PMStream D: Information Technology - Session 3
Chair: Stevens, Nichola; AstraZeneca
1:45 PM - 2:30 PMApplying GAMP 5 to data in R&D - How to maintain data integrity within GCP Processes
Henrichmann, Frank; PAREXEL International GmbH
2:30 PM - 3:15 PMManagement of mobile devices in a GxP regulated environment - Security and date integrity considerations
Montgomery, Chris; Boehringer Ingelheim
3:15 PM - 3:45 PMBreak

3:45 PM - 5:15 PMStream D: Information Technology - Session 4
Chair: Stevens, Nichola, AstraZeneca
3:45 PM - 4:30 PMContracted IT services - Advantages and disadvantages for a GxP environment
Taylor, Karen; AstraZeneca
4:30 PM - 5:15 PMGeneration 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
7:30 PMPRE DINNER DRINKS RECEPTION followed by DINNER DANCE

9:00 AM - 5:15 PMStream E: Pharmacovigilance/Medical Devices
SAAL HAYDN
9:00 AM - 11:00 AMStream E: Session 1 - PV
Chair: Jack, Allison; GlaxoSmithKline
9:00 AM - 9:45 AMMaster file requirements, expectations from a regulatory perspective
Halle, Dianne; ANSM
9:45 AM - 10:30 AMImplementing quality management systems
Wishart, Maria; GlaxoSmithKline
10:30 AM - 11:00 AMBreak

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

3:45 PM - 5:15 PMStream E: Session 4 - Medical Devices
Chair: Scholz, Bianca; Scholz Consulting
3:45 PM - 4:30 PMDifferences in regulatory pathways for combination products and the impact thereof in pharmacovigilance
Koch, Henry; QIMP Management Systems Ltd
4:30 PM - 5:15 PMMedical Device vigilance
Watt, Lindsay; GlaxoSmithKline
7:30 PMPRE DINNER DRINKS RECEPTION followed by DINNER DANCE

Friday, September 27, 2013
9:45 AM - 12:00 PMPlenary Session
SAAL MARITIM
9:45 AM - 11:00 AMPlenary Session 1 - EUROPE AND WHAT THE FUTURE HOLDS
Chairs: Steffen König, Laurent Bouillot and Louise Handy
9:45 AM - 10:30 AMThe future in Europe for big pharma and how regulations impact us everyday
Hamilton, Nigel; Sanofi
10:30 AM - 11:00 AMBreak

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

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