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 in landscape due to the pandemic are accelerating this evolution. This With a wider remit focused on RBQM, this Working Group will identify innovative approaches in risk management and data analytics to proactively manage data quality and subject safety risksthe 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 challenges with change management strategies related to moving towards embracing risk-based approaches. |
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 the Head of Centralized Monitoring at BMS. He is 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 | Marion Wolfs: 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 Marion 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 was 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. . |
