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
...
Programme
Wednesday, September 25, 2013
8:00 AM
- 12:45 PM
Plenary Session
SAAL MARITIM8:00 AM
Conference registration
9:00 AM
- 9:15 AM
Opening address
DGGF - Steffen König SoFAQ - Laurent Bouillot RQA - Louise Handy9:15 AM
- 10:45 AM
Session 1 - KEYNOTE SPEAKER
Chairs: Steffen König, Laurent Bouillot and Louise Handy
9:15 AM
- 10:15 AM
Risk Management - Lessons learnt from aviation
Müller, Manfred; Lufthansa
10:15 AM
- 10:45 AM
Break
10:45 AM
- 12:45 PM
Session 2
Chair: König Steffen; IST
10:45 AM
- 11:45 AM
Changes in European Regulation
Sweeney, Fergus; EMA
11:45 AM
- 12:45 PM
Risk-based quality management of clinical trials- What is special
about the concept
Schwarz, Gabriele; BfARM
12:45 PM
- 2:00 PM
Lunch
2:00 PM
- 6:15 PM
Stream One - Outsourcing - Vendor Oversight
SAAL REGER
2:00 PM
- 3:30 PM
Stream One - Outsourcing - Vendor Oversight - Session 3
Chair: Stevens, Nichola; Astra Zeneca
2:00 PM
- 2:45 PM
How can effective oversight be implemented to improve vendor
quality in clinical development?
Scaife, Richard; Mitsubishi Pharma Europe
2:45 PM
- 3:30 PM
QA Aspects/challenges with outsourced manufacturing including
impact of updated Chapter 7 of EU GMP, and the Falsified
Medicines Act
Porter, Steve; AstraZeneca, UK
4:00 PM
- 6:15 PM
Stream One - Outsourcing - Vendor Oversight - Session 4
Chair: Elliston, Jane; Battelle UK
4:00 PM
- 4:45 PM
Outsourcing - A study in human behaviour
Brown, Colin, Charles River Laboratories
4:45 PM
- 5:30 PM
A day in the life of a CRO: Everyday considerations for
outsourcing GLP
Furrow, Greg; WIL Research
5:30 PM
- 6:15 PM
Outsourcing challenges from a 'small' biotech perspective
Defert, Olivier; AMAKEN NV
2:00 PM
- 5:30 PM
Stream Two - Risk Management
SAAL MARITIM
2:00 PM
- 4:00 PM
Stream Two - Risk Management - Session 3
Chair: Liang, Catherine; Ricerca BioSciences
2:00 PM
- 2:45 PM
Quality risk management, how does that impact QA workload?
Piton, Alain; Galderma R&D
2:45 PM
- 3:30 PM
Risk - What happens if we get it wrong?
Horne, Barney; Novartis Pharma AG
3:30 PM
- 4:00 PM
Break
4:00 PM
- 5:30 PM
Stream Two - Risk Management - Session 4
Chair: König, Kerstin; Merck
4:00 PM
- 4:45 PM
Risk - How does it fit across quality roles?
Widler, Beat; Widler and Schiemann Ltd
4:45 PM
- 5:30 PM
Audit/quality strategies for GxP compliance
Ghent, Anne; Amgen Ltd
2:00 PM
- 5:30 PM
Stream Three - Data Challenges
SAAL SCHUMANN
2:00 PM
- 4:00 PM
Stream Three - Data Challenges - Session 3
Chair: Buot, Rose; Covance
2:00 PM
- 2:45 PM
Data exchanging
Kranich, Sylvia; SK Consulting
2:45 PM
- 3:30 PM
Digitalisation of documents in a GxP environment
Bursian, Michael; Grunenthal GmbH
3:30 PM
- 4:00 PM
Break
4:00 PM
- 5:30 PM
Stream Three - Data Challenges - Session 4
Programme
4:00 PM
- 4:45 PM
Can we destroy the paper?
Gittens, Gillian; Phlexglobal Ltd
4:45 PM
- 5:30 PM
Quality and eTMF implementation
Thorley, Martin; Pfizer
6:15 PM
- 7:15 PM
Meet the Delegate Drinks Reception
Thursday, September 26, 2013
9:00 AM
- 5:15 PM
Stream A: Good Laboratory Practice
SAAL MARITIM
9:00 AM
- 11:00 AM
Stream A: GLP - Session 1
Chair: Schepers, Ulrich; BASF SE, Crop Protection
9:00 AM
- 9:45 AM
Hamonisation of Compliance Monitoring Authority expectations
within OECD GLP community
Gray, Andrew; MHRA
9:45 AM
- 10:30 AM
Organisation and procedures of Italian Monitoring Authority
Meneguz, Annarita; Italian National Public Health
10:30 AM
- 11:00 AM
Break
11:00 AM
- 1:45 PM
Stream A: GLP - Session 2
Chair: Schepers, Ulrich; BASF SE, Crop Protection
11:00 AM
- 12:30 PM
GLP 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 PM
Stream A: GLP - Session 3
Chair: Liang, Catherine; Ricerca BioSciences
1:45 PM
- 2:30 PM
Multi-site studies - Who is really in control?
Davies, Peter; Peter Davies Associates
2:30 PM
- 3:15 PM
GLP certification experience in China
Mutch, Marian; Covance
3:15 PM
- 3:45 PM
Break
3:45 PM
- 5:15 PM
Stream A: GLP - Session 4
3:45 PM
- 4:30 PM
Analysis 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 PM
GLP Implementation at the University of Barcelona: The quality
research service
Navarro Aragay, Carmen; Barcelona University
7:30 PM
PRE DINNER DRINKS RECEPTION followed by DINNER
DANCE
9:00 AM
- 5:15 PM
Stream B: Good Manufacturing Practice/Animal Health
SAAL KOCH
9:00 AM
- 11:00 AM
Stream B: Session 1 - GMP
Chair: McAteer, Rhona; TMQA
9:00 AM
- 9:45 AM
Risk-based inspections
Stanbrook, Rebecca; MHRA
9:45 AM
- 10:30 AM
ANSM Inspection division activities and developments
Viornery, Lional; ANSM
10:30 AM
- 11:00 AM
Break
11:00 AM
- 1:45 PM
Stream B: Session 2 - GMP
Chair: Frankenberg, Nadine; Bureco AG
11:00 AM
- 11:45 AM
Preparation, organisation and follow-up of FDA
inspections/differences with EU inspections
Wiedner, Harald;QuasSyCon GmbH
11:45 AM
- 12:30 PM
GDP: Gaps discovered and prioritised - a risk-based approach to
the new EU GDP guidelines
Nadarajah, Sanjay; Inglasia Pharma Solutions
1:45 PM
- 3:45 PM
Stream B: Session 3 - Animal Health
Chair: Murphy, Marci; Boehringer Ingelheim Animal Health GmbH
1:45 PM
- 2:30 PM
Obtaining regulatory approval for clinical studies in Europe and
requirements for clinical supplies management
Schneider, Claudia; Klifovet AG
2:30 PM
- 3:15 PM
Monitoring multinational studies
Petersen, Ivo; MSD Animal Health Innovation GmbH
3:15 PM
- 3:45 PM
Break
3:45 PM
- 5:15 PM
Stream B: Session 4 - Animal Health
Programme
3:45 PM
- 4:30 PM
Globalisation/harmonisation and its impact for sponsors
Harris, Gareth; Merck
4:30 PM
- 5:15 PM
Help! What is EDC?
Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services
7:30 PM
PRE DINNER DRINKS RECEPTION followed by DINNER
DANCE
9:00 AM
- 5:15 PM
Stream C: Good Clinical Practice/Medical Devices/Non
Commercial
SAAL SCHUMANN
9:00 AM
- 11:00 AM
Stream C: Session 1 - GCP
Chair: Hartlieb-Wallthor-Sano Christiane
9:00 AM
- 9:45 AM
Voluntary authorisation procedures and EU CT Regulation
Szalay, Gudrun; Paul-Ehrlich Institute
9:45 AM
- 10:30 AM
MHRA GCP Guide: Applicable across Europe?
Wilsher, Colin; Consultant
10:30 AM
- 11:00 AM
Break
11:00 AM
- 1:45 PM
Stream C: Session 2 - GCP
Chair: Damour, Brigitte; Aptiv Solutions
11:00 AM
- 11:45 AM
Introduction to strategic knowledge management
Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich
11:45 AM
- 12:30 PM
Auditing in the digital age
Strickland, Paul; Strickland Quality Assurance Ltd
1:45 PM
- 3:45 PM
Stream C: Session 3 - GCP/Medical Devices
Chair: Tillmann, Angelika; Theorem Clinical Research
1:45 PM
- 2:30 PM
How secure are clinical data following ISO 14155?
Koehnen, Judith; Theorem Clinical Research GmbH & Co KG
2:30 PM
- 3:15 PM
The EU Medical Devices Directive and the role of Notified Bodies
O'Donnell, Matthew; BSI Group
3:15 PM
- 3:45 PM
Break
3:45 PM
- 5:15 PM
Stream C: Session 4 - GCP/Non Commercial
Chair: Tillmann, Angelika; Theorem Clinical Research
3:45 PM
- 4:30 PM
GCP, but not as we know it
4:30 PM
- 5:15 PM
Welcome to my planet: Non commercial research
Eldridge, Joy; University of Aberdeen/NHS Grampian
7:30 PM
PRE DINNER DRINKS RECEPTION followed by DINNER
DANCE
9:00 AM
- 5:15 PM
Stream D: Information Technology
SAAL REGER
9:00 AM
- 11:00 AM
Stream D: Information Technology - Session 1
Chair: Morgenthaler, Helmuth; DGGF
9:00 AM
- 9:45 AM
AGIT Guidance on change management - Compliant change
management in a GLP regulated environment
Hassler, Stephan; Harlan Laboratories Ltd
9:45 AM
- 10:30 AM
Vendor audit of an offshore IT development company - Process
and experiences
Regehr, Michael; BASF Corporation
10:30 AM
- 11:00 AM
Break
11:00 AM
- 1:45 PM
Stream D: Information Technology - Session 2
Chair: Morgenthaler, Helmuth; DGGF
11:00 AM
- 11:45 AM
Audit of IT services used pharma R&D - Technical challenges,
regulatory expectations, audit concepts
Reddy, Manu; Bayer HealthCare Pharmaceuticals
11:45 AM
- 12:30 PM
Application 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 PM
Stream D: Information Technology - Session 3
Chair: Stevens, Nichola; AstraZeneca
1:45 PM
- 2:30 PM
Applying 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 PM
Management of mobile devices in a GxP regulated environment
-Security and date integrity considerations
Montgomery, Chris; Boehringer Ingelheim
3:15 PM
- 3:45 PM
Break
3:45 PM
- 5:15 PM
Stream D: Information Technology - Session 4
Programme
3:45 PM
- 4:30 PM
Contracted IT services - Advantages and disadvantages for a GxP
environment
Taylor, Karen; AstraZeneca
4:30 PM
- 5:15 PM
Generation 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 PM
PRE DINNER DRINKS RECEPTION followed by DINNER
DANCE
9:00 AM
- 5:15 PM
Stream E: Pharmacovigilance/Medical Devices
SAAL HAYDN
9:00 AM
- 11:00 AM
Stream E: Session 1 - PV
Chair: Jack, Allison; GlaxoSmithKline
9:00 AM
- 9:45 AM
Master file requirements, expectations from a regulatory
perspective
Halle, Dianne; ANSM
9:45 AM
- 10:30 AM
Implementing quality management systems
Wishart, Maria; GlaxoSmithKline
10:30 AM
- 11:00 AM
Break
11:00 AM
- 2:45 PM
Stream E: Session 2 - PV
Chair: Bones, Pam; Allergan Ltd
11:00 AM
- 11:45 AM
Implementation of Good Pharmacovigilance Practices Guidelines
Modules 1-1V - A CRO QA perspective
Powell, Helen; InVentiv Health Clinical
11:45 AM
- 12:30 PM
The 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 PM
Stream E: Session 3 - PV
Chair: Scholz, Bianca; Scholz Consulting
1:45 PM
- 2:30 PM
Managing patient safety in the EU - One year of experience with
the new PV legislation
Pietrek, Monika; Pietrek Associates GmbH
2:30 PM
- 3:15 PM
European risk management systems
Becker Susanne; Spm2
3:45 PM
- 5:15 PM
Stream E: Session 4 - Medical Devices
Chair: Scholz, Bianca; Scholz Consulting
3:45 PM
- 4:30 PM
Differences in regulatory pathways for combination products and
the impact thereof in pharmacovigilance
Koch, Henry; QIMP Management Systems Ltd
4:30 PM
- 5:15 PM
Medical Device vigilance
Watt, Lindsay; GlaxoSmithKline
7:30 PM
PRE DINNER DRINKS RECEPTION followed by DINNER
DANCE
Friday, September 27, 2013
9:45 AM
- 12:00 PM
Plenary Session
SAAL MARITIM
9:45 AM
- 11:00 AM
Plenary Session 1 - EUROPE AND WHAT THE FUTURE HOLDS
Chairs: Steffen König, Laurent Bouillot and Louise Handy
9:45 AM
- 10:30 AM
The future in Europe for big pharma and how regulations impact
us everyday
Hamilton, Nigel; Sanofi
10:30 AM
- 11:00 AM
Break
11:00 AM
- 12:00 PM
Plenary Session 2 - CONFERENCE REVIEW AND SUMMARY
Chairs: Steffen König, Laurent Bouillot and Louise Handy
11:00 AM
- 11:45 AM
Summary of the conference - What have we learned
Waddell, Andrew; TMQA
11:45 AM
- 12:00 PM
Conference closing presentation
DGGF - Steffen König SoFAQ - Laurent Bouillot RQA - Louise Handy
Titles
A day in the life of a CRO: Everyday considerations for outsourcing GLP
Furrow, Greg; WIL Research
Wednesday, September 25, 2013, 4:45 PM - 5:30 PM
AGIT Guidance on change management - Compliant change management in a GLP regulated
environment
Hassler, Stephan; Harlan Laboratories Ltd
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Analysis 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
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
ANSM Inspection division activities and developments
Viornery, Lional; ANSM
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Application 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
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Applying GAMP 5 to data in R&D - How to maintain data integrity within GCP Processes
Henrichmann, Frank; PAREXEL International GmbH
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Audit of IT services used pharma R&D - Technical challenges, regulatory expectations, audit
concepts
Reddy, Manu; Bayer HealthCare Pharmaceuticals
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
Audit/quality strategies for GxP compliance
Ghent, Anne; Amgen Ltd
Wednesday, September 25, 2013, 4:45 PM - 5:30 PM
Auditing in the digital age
Strickland, Paul; Strickland Quality Assurance Ltd
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Can we destroy the paper?
Gittens, Gillian; Phlexglobal Ltd
Wednesday, September 25, 2013, 4:00 PM - 4:45 PM
Changes in European Regulation
Sweeney, Fergus; EMA
Wednesday, September 25, 2013, 10:45 AM - 11:45 AM
Conference closing presentation
DGGF - Steffen König SoFAQ - Laurent Bouillot RQA - Louise Handy
Contracted IT services - Advantages and disadvantages for a GxP environment
Taylor, Karen; AstraZeneca
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
Data exchanging
Kranich, Sylvia; SK Consulting
Wednesday, September 25, 2013, 2:00 PM - 2:45 PM
Differences in regulatory pathways for combination products and the impact thereof in
pharmacovigilance
Koch, Henry; QIMP Management Systems Ltd
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
Digitalisation of documents in a GxP environment
Bursian, Michael; Grunenthal GmbH
Wednesday, September 25, 2013, 2:45 PM - 3:30 PM
European risk management systems
Becker Susanne; Spm2
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
GCP, but not as we know it
Henley, Patricia; London School of Hygiene and Tropical Medicine
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
GDP: Gaps discovered and prioritised - a risk-based approach to the new EU GDP guidelines
Nadarajah, Sanjay; Inglasia Pharma Solutions
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Generation 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
Thursday, September 26, 2013, 4:30 PM - 5:15 PM
Globalisation/harmonisation and its impact for sponsors
Harris, Gareth; Merck
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
GLP certification experience in China
Mutch, Marian; Covance
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
GLP Implementation at the University of Barcelona: The quality research service
Navarro Aragay, Carmen; Barcelona University
Thursday, September 26, 2013, 4:30 PM - 5:15 PM
GLP 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
Titles
Hamonisation of Compliance Monitoring Authority expectations within OECD GLP community
Gray, Andrew; MHRA
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Help! What is EDC?
Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services
Thursday, September 26, 2013, 4:30 PM - 5:15 PM
How can effective oversight be implemented to improve vendor quality in clinical development?
Scaife, Richard; Mitsubishi Pharma Europe
Wednesday, September 25, 2013, 2:00 PM - 2:45 PM
How secure are clinical data following ISO 14155?
Koehnen, Judith; Theorem Clinical Research GmbH & Co KG
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Implementation of Good Pharmacovigilance Practices Guidelines Modules 1-1V - A CRO QA
perspective
Powell, Helen; InVentiv Health Clinical
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
Implementing quality management systems
Wishart, Maria; GlaxoSmithKline
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Introduction to strategic knowledge management
Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
Management of mobile devices in a GxP regulated environment - Security and date integrity
considerations
Montgomery, Chris; Boehringer Ingelheim
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
Managing patient safety in the EU - One year of experience with the new PV legislation
Pietrek, Monika; Pietrek Associates GmbH
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Master file requirements, expectations from a regulatory perspective
Halle, Dianne; ANSM
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Medical Device vigilance
Watt, Lindsay; GlaxoSmithKline
Thursday, September 26, 2013, 4:30 PM - 5:15 PM
MHRA GCP Guide: Applicable across Europe?
Wilsher, Colin; Consultant
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Monitoring multinational studies
Petersen, Ivo; MSD Animal Health Innovation GmbH
Multi-site studies - Who is really in control?
Davies, Peter; Peter Davies Associates
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Obtaining regulatory approval for clinical studies in Europe and requirements for clinical supplies
management
Schneider, Claudia; Klifovet AG
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Organisation and procedures of Italian Monitoring Authority
Meneguz, Annarita; Italian National Public Health
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Outsourcing - A study in human behaviour
Brown, Colin, Charles River Laboratories
Wednesday, September 25, 2013, 4:00 PM - 4:45 PM
Outsourcing challenges from a 'small' biotech perspective
Defert, Olivier; AMAKEN NV
Wednesday, September 25, 2013, 5:30 PM - 6:15 PM
Preparation, organisation and follow-up of FDA inspections/differences with EU inspections
Wiedner, Harald;QuasSyCon GmbH
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
QA Aspects/challenges with outsourced manufacturing including impact of updated Chapter 7 of
EU GMP, and the Falsified Medicines Act
Porter, Steve; AstraZeneca, UK
Wednesday, September 25, 2013, 2:45 PM - 3:30 PM
Quality and eTMF implementation
Thorley, Martin; Pfizer
Wednesday, September 25, 2013, 4:45 PM - 5:30 PM
Quality risk management, how does that impact QA workload?
Piton, Alain; Galderma R&D
Wednesday, September 25, 2013, 2:00 PM - 2:45 PM
Risk - How does it fit across quality roles?
Widler, Beat; Widler and Schiemann Ltd
Wednesday, September 25, 2013, 4:00 PM - 4:45 PM
Risk - What happens if we get it wrong?
Horne, Barney; Novartis Pharma AG
Wednesday, September 25, 2013, 2:45 PM - 3:30 PM
Risk Management - Lessons learnt from aviation
Müller, Manfred; Lufthansa
Wednesday, September 25, 2013, 9:15 AM - 10:15 AM
Risk-based inspections
Stanbrook, Rebecca; MHRA
Titles
Risk-based quality management of clinical trials- What is special about the concept
Schwarz, Gabriele; BfARM
Wednesday, September 25, 2013, 11:45 AM - 12:45 PM
Summary of the conference - What have we learned
Waddell, Andrew; TMQA
Friday, September 27, 2013, 11:00 AM - 11:45 AM
The EU Medical Devices Directive and the role of Notified Bodies
O'Donnell, Matthew; BSI Group
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
The future in Europe for big pharma and how regulations impact us everyday
Hamilton, Nigel; Sanofi
Friday, September 27, 2013, 9:45 AM - 10:30 AM
The use of relational modelling as a tool to detect safety signals amongst patients' web posts
Sawyer, James; Prism Ideas Ltd
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Vendor audit of an offshore IT development company - Process and experiences
Regehr, Michael; BASF Corporation
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Voluntary authorisation procedures and EU CT Regulation
Szalay, Gudrun; Paul-Ehrlich Institute
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Welcome to my planet: Non commercial research
Eldridge, Joy; University of Aberdeen/NHS Grampian
Abdon, Dominique; Safety and Pharmacovigilance Inspection Unit, France
GLP Round table discussion - Questions and answers
Thursday, September 26, 2013, 11:00 AM - 12:30 PM
Bauer, Ronald; Austrian Agency for Health and Food Safety, Austria
GLP Round table discussion - Questions and answers
Thursday, September 26, 2013, 11:00 AM - 12:30 PM
Becker Susanne; Spm2
European risk management systems
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
Brown, Colin, Charles River Laboratories
Outsourcing - A study in human behaviour
Wednesday, September 25, 2013, 4:00 PM - 4:45 PM
Bulling, Wolf ; Federal Institute for Risk Assessment, Germany
GLP Round table discussion - Questions and answers
Thursday, September 26, 2013, 11:00 AM - 12:30 PM
Bursian, Michael; Grunenthal GmbH
Digitalisation of documents in a GxP environment
Wednesday, September 25, 2013, 2:45 PM - 3:30 PM
Dalz, Reinhard; Ernst & Young GmbH Wirtschaftsprufungsgeesellschaft
Application of principles of GLP - Principles to a business process driven SOA environment - Prerequisites, flexibility and efficiency in a heterogeneous IT landscape
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Davies, Peter; Peter Davies Associates
Multi-site studies - Who is really in control?
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Defert, Olivier; AMAKEN NV
Outsourcing challenges from a 'small' biotech perspective
Wednesday, September 25, 2013, 5:30 PM - 6:15 PM
DGGF - Steffen König
Conference closing presentation
Friday, September 27, 2013, 11:45 AM - 12:00 PM
Opening address
Wednesday, September 25, 2013, 9:00 AM - 9:15 AM
Eldridge, Joy; University of Aberdeen/NHS Grampian
Welcome to my planet: Non commercial research
Presenters
Fleischhauer, Ilona; Fraunhofer Institute for Toxicology and Experimental Medicine
Analysis of clinical trial samples: What is important for a GLP laboratory according to the EMA reflection paper?
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
Furrow, Greg; WIL Research
A day in the life of a CRO: Everyday considerations for outsourcing GLP
Wednesday, September 25, 2013, 4:45 PM - 5:30 PM
Ghent, Anne; Amgen Ltd
Audit/quality strategies for GxP compliance
Wednesday, September 25, 2013, 4:45 PM - 5:30 PM
Gittens, Gillian; Phlexglobal Ltd
Can we destroy the paper?
Wednesday, September 25, 2013, 4:00 PM - 4:45 PM
Gray, Andrew Gray; MHRA
GLP Round table discussion - Questions and answers
Thursday, September 26, 2013, 11:00 AM - 12:30 PM
Gray, Andrew; MHRA
Hamonisation of Compliance Monitoring Authority expectations within OECD GLP community
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Halle, Dianne; ANSM
Master file requirements, expectations from a regulatory perspective
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Hamilton, Nigel; Sanofi
The future in Europe for big pharma and how regulations impact us everyday
Friday, September 27, 2013, 9:45 AM - 10:30 AM
Harris, Gareth; Merck
Globalisation/harmonisation and its impact for sponsors
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
Hassler, Stephan; Harlan Laboratories Ltd
AGIT Guidance on change management - Compliant change management in a GLP regulated environment
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Henley, Patricia; London School of Hygiene and Tropical Medicine
GCP, but not as we know it
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
Henrichmann, Frank; PAREXEL International GmbH
Applying GAMP 5 to data in R&D - How to maintain data integrity within GCP Processes
Horne, Barney; Novartis Pharma AG
Risk - What happens if we get it wrong?
Wednesday, September 25, 2013, 2:45 PM - 3:30 PM
Koch, Henry; QIMP Management Systems Ltd
Differences in regulatory pathways for combination products and the impact thereof in pharmacovigilance
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
Koehnen, Judith; Theorem Clinical Research GmbH & Co KG
How secure are clinical data following ISO 14155?
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Kranich, Sylvia; SK Consulting
Data exchanging
Wednesday, September 25, 2013, 2:00 PM - 2:45 PM
Kretzschmar, Timo; Pharm-analyt Labor GmbH
Generation of user requirements specifications to establish a tailored GxP compliant LIMS for a typical bioanalytical CRO -Highlights and pitfalls
Thursday, September 26, 2013, 4:30 PM - 5:15 PM
Meneguz, Annarita; Italian National Public Health
Organisation and procedures of Italian Monitoring Authority
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Meneguz, Annarita; National Public Health Institute, Italy
GLP Round table discussion - Questions and answers
Thursday, September 26, 2013, 11:00 AM - 12:30 PM
Montgomery, Chris; Boehringer Ingelheim
Management of mobile devices in a GxP regulated environment - Security and date integrity considerations
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
Müller, Manfred; Lufthansa
Risk Management - Lessons learnt from aviation
Wednesday, September 25, 2013, 9:15 AM - 10:15 AM
Mutch, Marian; Covance
GLP certification experience in China
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
Nadarajah, Sanjay; Inglasia Pharma Solutions
GDP: Gaps discovered and prioritised - a risk-based approach to the new EU GDP guidelines
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Presenters
GLP Implementation at the University of Barcelona: The quality research service
Thursday, September 26, 2013, 4:30 PM - 5:15 PM
Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich
Introduction to strategic knowledge management
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
O'Donnell, Matthew; BSI Group
The EU Medical Devices Directive and the role of Notified Bodies
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
Petersen, Ivo; MSD Animal Health Innovation GmbH
Monitoring multinational studies
Thursday, September 26, 2013, 2:30 PM - 3:15 PM
Pietrek, Monika; Pietrek Associates GmbH
Managing patient safety in the EU - One year of experience with the new PV legislation
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Piton, Alain; Galderma R&D
Quality risk management, how does that impact QA workload?
Wednesday, September 25, 2013, 2:00 PM - 2:45 PM
Porter, Steve; AstraZeneca, UK
QA Aspects/challenges with outsourced manufacturing including impact of updated Chapter 7 of EU GMP, and the Falsified Medicines Act
Wednesday, September 25, 2013, 2:45 PM - 3:30 PM
Powell, Helen; InVentiv Health Clinical
Implementation of Good Pharmacovigilance Practices Guidelines Modules 1-1V - A CRO QA perspective
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
Reddy, Manu; Bayer HealthCare Pharmaceuticals
Audit of IT services used pharma R&D - Technical challenges, regulatory expectations, audit concepts
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
Regehr, Michael; BASF Corporation
Vendor audit of an offshore IT development company - Process and experiences
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
RQA - Louise Handy
Conference closing presentation
Friday, September 27, 2013, 11:45 AM - 12:00 PM
Opening address
Wednesday, September 25, 2013, 9:00 AM - 9:15 AM
The use of relational modelling as a tool to detect safety signals amongst patients' web posts
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Scaife, Richard; Mitsubishi Pharma Europe
How can effective oversight be implemented to improve vendor quality in clinical development?
Wednesday, September 25, 2013, 2:00 PM - 2:45 PM
Schepers, Ulrich Schepers; BASF
GLP Round table discussion - Questions and answers
Thursday, September 26, 2013, 11:00 AM - 12:30 PM
Schneider, Claudia; Klifovet AG
Obtaining regulatory approval for clinical studies in Europe and requirements for clinical supplies management
Thursday, September 26, 2013, 1:45 PM - 2:30 PM
Schwarz, Gabriele; BfARM
Risk-based quality management of clinical trials- What is special about the concept
Wednesday, September 25, 2013, 11:45 AM - 12:45 PM
SoFAQ - Laurent Bouillot
Conference closing presentation
Friday, September 27, 2013, 11:45 AM - 12:00 PM
Opening address
Wednesday, September 25, 2013, 9:00 AM - 9:15 AM
Stanbrook, Rebecca; MHRA
Risk-based inspections
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Strickland, Paul; Strickland Quality Assurance Ltd
Auditing in the digital age
Thursday, September 26, 2013, 11:45 AM - 12:30 PM
Sweeney, Fergus; EMA
Changes in European Regulation
Wednesday, September 25, 2013, 10:45 AM - 11:45 AM
Szalay, Gudrun; Paul-Ehrlich Institute
Voluntary authorisation procedures and EU CT Regulation
Thursday, September 26, 2013, 9:00 AM - 9:45 AM
Taylor, Karen; AstraZeneca
Contracted IT services - Advantages and disadvantages for a GxP environment
Thursday, September 26, 2013, 3:45 PM - 4:30 PM
Presenters
Quality and eTMF implementation
Wednesday, September 25, 2013, 4:45 PM - 5:30 PM
Viornery, Lional; ANSM
ANSM Inspection division activities and developments
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Waddell, Andrew; TMQA
Summary of the conference - What have we learned
Friday, September 27, 2013, 11:00 AM - 11:45 AM
Watt, Lindsay; GlaxoSmithKline
Medical Device vigilance
Thursday, September 26, 2013, 4:30 PM - 5:15 PM
Widler, Beat; Widler and Schiemann Ltd
Risk - How does it fit across quality roles?
Wednesday, September 25, 2013, 4:00 PM - 4:45 PM
Wiedner, Harald;QuasSyCon GmbH
Preparation, organisation and follow-up of FDA inspections/differences with EU inspections
Thursday, September 26, 2013, 11:00 AM - 11:45 AM
Wilsher, Colin; Consultant
MHRA GCP Guide: Applicable across Europe?
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Wishart, Maria; GlaxoSmithKline
Implementing quality management systems
Thursday, September 26, 2013, 9:45 AM - 10:30 AM
Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services
Help! What is EDC?