Working Group Scope |
Although Risk Based Monitoring is no longer considered a new way of working, it continues to stay an area that is constantly evolving. Changes is landscape due to the pandemic are accelerating this evolution.
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 |
The Risk Based Monitoring Feedback Loop Community Forum |
Marion Wolf: Working Group Lead
Marion Wolfs is Head, Risk Management-Central Monitoring (RM-CM) within the Integrated Data Analytics and Reporting (IDAR) organisation from Janssen Pharmaceutical Companies of JnJ.
In this role she is provides leadership and strategic direction for all activities in the RM-CM department and oversees enterprise wide implementation of ARBM at JnJ.
Marion joined the pharmaceutical industry in 2007 and worked in various clinical operations roles until joining the Risk Management-Central Monitoring Group in October 2014. She has been the RBM TransCelerate co-lead from 2016 till 2019.
She holds a Master of Science degree in Biomedical Sciences from the Maastricht University and an International Certificate in Enterprise Risk Management from IRM in London.
Andy Lawton: Working Group Lead
Andy Lawton is a consultant for Risk Based Approach Ltd, specialising in business changes related to ICH (E6 R2/3 and E8 R1), in particular QTL’s, QbD and RBM.
Andy has been working in the clinical development arena for over 42 years and has covered most roles/tasks and was a Founding Committee Member of ACDM, Member of TransCelerate RBM, QTL, Data Transparency, eSource work streams and also a Member of EFPIA WG on Data Transparency.
In addition to the Working Group Lead role, Andy will be Co-Lead for the Quality Tools Limit ProjectTolerance Limits in the Pharmaceutical Industry White Paper |
Challenges in Central Monitoring Implementation White Paper |
Defining Central Monitoring Value White Paper |
 Jennifer Krohn Jennifer Krohn, MS, currently serves as a 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. |  Jeremy Howells 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 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. |