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.

Current Projects

Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials

Enhancing the Clinical Trial Risk Assessment Process

OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM

Quality Tolerance Limits – Threshold Setting Methodologies

Resources and Deliverables

The Risk Based Monitoring Feedback Loop

Community Forum

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@roche.com

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.

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.

jenn.krohn@gilead.com

Jennifer Krohn, MS, currently serves as Associate Director, RBQM at Gilead Sciences. In her role, Jenn advises study teams on implementing risk-based monitoring strategies and leads initiatives working to develop enhanced technology and processes for centralised monitoring, risk assessments and site monitoring approaches. This role expands upon her 16 years’ experience in the CRO sector, where she spent a decade helping build centralised monitoring, leading data analyst teams and serving as QTL BPO. Prior to the RBQM space, Jenn worked in a variety of clinical trial roles across a wide range of therapeutic areas, from the site level as study coordinator, to the CRO side in clinical operations (CRA), data management and feasibility.

Jenn previously co-led the Central Monitoring project, under the PHUSE RBQM Working Group. She holds a master’s degree in biology with a focus in biochemistry and physiology from the University of North Carolina Wilmington.