2nd European QA Conference

The 2nd European QA Conference took place at the Nice Acropolis, Nice, France during the 27-29 April 2016.

The following presentations are available to delegates only. There are some presentations which we are not allowed to feature here.

These presentations are for delegates personal use and must not be shown outside of this context as permission has not been granted for any other use.

The presentations will remain on this site until 31 July 2016.

Wednesday 27 January 2016

Smart Quality
Session 1

09.30hrs
Global pharmaceutical regulation: Plea for further harmonisation - Thierry Bourquin, Sanofi
Presentation unavailable

Smart Quality
Session 2

11.00hrs
Considerations for the use of Electronic Media and IT Tools in Clinical Trials - Gabriele Schwarz, Federal Institute for Drugs and Medical Devices

11.45hrs
A TransCelerate QMS - Issue Management Conceptual Framework - From Challenges to Opportunities - Susan Callery-D'Amico, AbbVie

Stream 1

Data Integrity - are we still in control?
Session 3

14.00hrs
Ensuring data integrity - mitigation of risks - Wolfgang Schumacher, La Roche Ltd

14.45hrs
Data integrity QA how monitoring discovery activities can inform GxP oversight - Jon Bartlett, GlaxoSmithKline

Data Integrity - are we still in control?
Session 4

16.00hrs
OECD  advisory document 'The application of GLP Principles to Computerised Systems' - Ronald Bauer, Austrian Agency for Health and Food Safety

16.45hrs
Current practices of electronic archiving in the GLP environment - field reports from Sanofi-Aventis and Boehringer Ingelheim - Andreas Kirchoff, Boehringer Ingelheim and Andreas Henrichs, Sanofo-Aventis Deutschland GmbH

Stream 2

CAPA
Session 3

14.00hrs
Root Cause Analysis and CAPA management - Eileen Lumsden, GlaxoSmithKline

14.45hrs
CAPA Effectiveness- Friederike Spengler, Chiltern

QMS
Session 4

16.00hrs
Lean Quality Management Systems - Lena Vagberg, AstraZeneca

16.45hrs
QMS Systems, belended or singles? - Alain Piton, ALP Quality Systems

 

Thursday 28 April 2016

Stream A

Risk Management
Session 1

09.00hrs
Challenges for implementing an efficient risk management system example of ICH Q9 - Olga Croso Bonnier

09.45hrs
Risk management versus quality management - Kevin Perkins, GlaxoSmithKline

Risk Management
Session 2

11.00hrs
How ISO standards have influenced Quality Risk Management - James Vesper, LearningPlus Inc.

11.45hrs
ISO 14971 - Risk management for medical devices - Anette Sjogren, PREVENTIA AB

Good Clinical Practice
Session 3

13.45hrs
FDA Inspections at sponsors from 2011-2015 - Rita Hattemer-Apostel, Verdandi AG
Presentation unavailable

14.30hrs
Risk-based monitoring - Are we losing the plot? - Paul Strickland, Strickland Quality Assurance Ltd

Good Clinical Practice
Session 4

15.45hrs
Good Clinical Practice QA Clinic - Michael Smith, ONO Pharma UK Ltd

Stream B

Inspection Strategies Management
Session 1

09.00hrs
Practical look at inspection behaviour - Alun Maxwell
No presentation unavailable

09.45hrs
Good Pharmacovigilance Practices (GvPs) - the relevance for GCP/GMP - Shelley Gandhi, NDA Regulatory Science Ltd
Presentation unavailable

Inspection Strategies Management
Session 2

11.00hrs
Inspection of bioquivalence trials: examples of findings and perspectives - Olivier Le Blaye, ANSM
Presentation unavailable

11.45hrs
GCP Inspections - Lessons learned? - Eva-Maria Jahn, Paul-Ehrlich-Institut

Good Laboratory Practice
Session 3

13.45hrs
Risk-based QA in a GLP environment - is it possible? - Vanessa Grant, Envigo

14.30hrs
A glimpse to the global CRO market - Herman Lehn, Lehn Consulting

Good Laboratory Practice
Session 4

15.45hrs
Good Laboratory Practice Round Table Discussion
No presentation unavailable

Stream C

Standards to Support Life Sciences
Session 1

09.00hrs
ISO 13485 - Quality management for medical devices: relationship to other quality management systems and its future - Anette Sjogren, PREVENTIA AB

09.45hrs
ISO 10993 Standard for Biocompatibility - Monica Grekula

Standards to Support Life Sciences
Session 2

11.00hrs
Regulatory expectations for human tissue act - Anthony Chadwick

11.45hrs
Practical use of the Revised Cleanroom Standards ISO 14644 Part 1 and Part 2
Presentation cancelled - Speaker unavailable

Good Pharmacovigilance Practice
Session 3

13.45hrs
Four years later: Have the GVP modules really increased patients safety? - Susanne Kienzle-Horn, SCRATCH PV GmbH

14.30hrs
Benchmarking Survey on the PV System Master File - Calvin Johnson, AbbVie

Good Pharmacovigilance Practice
Session 4

15.45hrs
PV QA Round Table Discussion
No presentation unavailable

Stream D

Good Manufacturing Practice
Session 3

13.45hrs
Simplification of Quality Management Systems (QMS) - Verena Wieser, Baxalta Innovations GmbH

14.30hrs
Management review and quality metrics - Christian Gausepohl, Rottendorf Pharma GmbH

Good Manufacturing Pracrice
Session 4

15.45hrs
Good Manufacturing Practice QA Clinic

Stream E

Commercial/Academia
Session 3

13.45hrs
Scientific integrity within a university setting - Patricia Henley, London School of Hygiene and Tropical Medicine

14.30hrs
RQA and Global Engagement - Tim Stiles, Qualogy

Medical Devices
session 4

15.45hrs
Medical Devices QA Clinic

Stream F

IS/IT
Session 4

15.45hrs
Computer System Validation and Cloud Computing

Stream G

Animal Health
Session 4

15.45hrs Animal Health QA Clinic

 

Friday 29 April 2016

European Harmonised Quality
Session 1

09.00hrs
Social Listening for Post-Marketing Safety Surveillance - Cath Harvey, GlaxoSmithKline

09.45hrs
EMA Update - Anabela Marcal, EMA

European Harmonised Quality
Session 2

11.00hrs
GLP global overview - OECD Working Group update, Pernille Jorgensen, Novo Nordisk A/S