Risk Based Quality Management
- Former user (Deleted)
- Nicola Newton
- Former user (Deleted)
Working Group Scope |
With a wider remit focused on RBQM, this Working Group will identify innovative approaches in the planning (Quality by Design, Critical to Quality, Risk Identification and Characterisation), conduct (Risk Control), and continuous improvement (Risk Review, Risk Communication) elements of RBQM that support proactive management data reliability and participant well-being. The Working Group will support the pharmaceutical industry with change management strategies related to embracing risk-based approaches. |
| Resources and Deliverables |
Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry. White Paper |
Challenges in Central Monitoring Implementation White Paper |
Defining Central Monitoring Value White Paper |
Jeremy Howells is a People & Product Leader in the Data Strategy & Delivery, Data Sciences group at Roche. Jeremy has a BSc in Maths from Cardiff University and 15+ years’ experience as a stats programmer. His career in pharmaceutical biometrics began at GlaxoSmithKline in 2006 as a placement statistician. He joined Roche in 2012 as a statistical programmer, working for about seven years across the lifecycle of drug development. In 2019 he made the move into clinical data management as a People Manager, evolving into his current role in 2021. It was here he began his current involvement in risk-based quality management as the Product Operational Expert for QTLs at Roche. Jeremy is a member of the PHUSE QTL Working Group project. |
Michael Walega is an independent contributor but was previously the Head of Centralized Monitoring at BMS. He was responsible for providing protocol teams with actionable insights to achieve higher quality, ensuring centralised monitoring processes are aligned to relevant regulatory requirements, and championing risk-based quality management approaches to clinical trial monitoring activities. He was previously at LabCorp/Covance, where he led the team responsible for development and growth of Covance’s Risk-Based Monitoring (RBM) solutions, processes and operational delivery. He also led the Late-Stage Biostatistics and Programming groups, as well as the Process Excellence team. Michael is a qualified biostatistician and a Six Sigma Master Black Belt. |
MIREILLE.LOVEJOY@gehealthcare.com Mireille Lovejoy currently serves as Director, Clinical Risk Management and Process Excellence at GE HealthCare, a role dedicated to the design and implementation of Risk Based Quality Management (RBQM) and quality at the system level within diagnostic clinical trials. Mireille has extensive experience of RBQM having previously led the development of processes, resources, and technology underpinning the approach within 2 bio-pharmaceutical companies. She was a member of the TransCelerate BioPharma Risk-Based Monitoring initiative and was one of the original RACT developers. Mireille has over 30 years of experience in clinical research and drug development where she assumed leadership positions in clinical operations as well as clinical data management. She offers a balanced perspective of life within Pharma and CROs across a variety of therapeutic areas. Mireille holds a BSc in Biochemistry and Physiology from the University of Reading. | |
