Quality Assurance and Translational Science (QATS) Network Group

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Overview

The QATS Network Group supports translational research, with a focus on high levels of quality and regulatory compliance.

Mission Statement

The ECMC QATS Network Group supports and enables ECMCs to conduct translational research to the appropriate levels of quality and regulatory compliance, utilising validated, cutting-edge techniques.

Remit

How to achieve good QA across the Network
Mentoring in quality assurance processes - through networking and sharing expertise and resources
Training courses based on members' needs
Keeping abreast of new developments in the regulatory domain
Engaging with key stakeholders (MHRA, EMA & RQA)
Advising on how best to embed QA in network processes
Conducting translational science to the appropriate quality standards
Sponsoring training courses in relevant 'hot topics' based on assessment of members' needs
Embracing new developments in translational science by conducting workshops on cutting-edge technologies
Setting performance standards for biomarkers assays
Identification of promising new techniques and technology
Rapid adoption and development of new technologies

Steering Committee Members

Bill Greenhalf, Liverpool (Chair)
Bride Foster, Cambridge
Debora Joseph-Pietras, Southampton
Fiona Kelly, Centre for Drug Development, Cancer Research UK
Kate Rolfvondenbaumen, Southampton
Sarah Smalley, Centre for Drug Development, Cancer Research UK
Karen Swales, ICR
Fiona Thomson, Glasgow

Resources

Quality Assurance (QA) areas of expertise

27 Jun 2016

The purpose of the Quality Assurance (QA) areas of expertise document is to make those working in QA within the ECMC Network aware of others working in the same area and to give you an idea of who you can contact with certain queries.

ECMC Network: QA areas of expertise (pdf)

Please note that by appearing in this listing, people are not claiming to be experts in any given area and you are not obliged to follow any advice that you receive.

If you would like to be included in this listing, please email hannah.brown@cancer.org.uk

Audits and Inspections workshop - 19 April 2016

19 Apr 2016

Agenda
Inspections: an academic perspective - Patricia Henley, LSHTM
The audit programme - Elena Perez Del Notario, Cancer Research UK
Planning the audit - Hilary Vitkus, Cancer Research UK and Tony Price, Manchester ECMC
Successful conduct of the audit - Sara Yeats, Southampton ECMC
Report and Responses - Rebecca Gallagher, Belfast ECMC
Auditing computer systems - Tony Price, Manchester ECMC

Future direction and plans for the ECMC QATS Network Group - 21 May 2015

21 May 2015

Agenda
Summary from the QATS meeting on 25 February - Karen Swales, ICR
ECMC QATS Network Group: next steps
Ways of working for the QATS Network Group - Alex MacLellan, Edinburgh

10th Anniversary Symposium of the ECMC QATS Network Group - 14 May 2014

14 May 2014

Agenda (PDF)
Reflections on the ECMC QATS Network Group - Jeff Cummings, Manchester (PDF)
The new EU Clinical Trials Regulation - Paul Stewart, Cancer Research UK (PDF)
Cancer Biomarkers: Hope, hype or help. Does the past predict the future? - Andrew Hughes, AstraZeneca (PDF)
Molecular phenotype driven therapy for pancreatic cancer - David Chang, Glasgow (PDF)

ECMC QA Managers meeting - 20 March 2014

20 Mar 2014

Agenda (PDF)
Presentation on consent - Professor Nalin Thakker, Manchester (PDF)
Presentation on serious breaches/audit findings - Dr Andrew Waddell, TMQA (PDF)

ECMC GCP Training Day - 20 November 2013

20 Nov 2013

Agenda (PDF)
EMA Reflection Paper - Key points and clarifications - Paul Stewart, Cancer Research UK (PDF)
Computerised systems - seeing the wood from the trees - Tony Price, Manchester (PDF)
Use of informatics systems to link laboratory with clinical data and ensure GCP compliance - Bill Greenhalf, Liverpool (PDF)
The role of QC in sample analysis - Jeff Cummings, Manchester (PDF)
Summary of the Q&A Panel Session (PDF, 575KB)