Have you heard the news? CluePoints is sponsoring RBQM Live on behalf of the industry!
The adoption of Risk-Based Quality Management (RBQM) is accelerating, and it’s more important than ever for the industry to come together and share expertise. Taking place on May 20-21, 2021, this two-day live virtual event is a definitive guide for anyone working with RBQM – from beginners to experts. You can register now for a free e-pass here.
Ken Getz, Professor of TUFTS CSDD, is the keynote speaker for day one (May 20). Ken will provide a compelling look at how the COVID-19 pandemic has transformed the drug development operating environment and explore where the industry will be post-pandemic.
Sy Pretorius, Parexel’s President, Clinical Development and Chief Medical Officer, is the lead-off speaker for day two (May 21) exploring the impact of COVID-19 on adoption of digital applications, decentralized models and remote monitoring. Sy will discuss clinical data challenges and the growing imperative to adopt risk-based thinking and management throughout clinical development, illustrated with case study snapshots.
CluePoints is honoured to play a part in bringing this extraordinary industry event to fruition. The speaking delegation represents a ‘Who’s Who of RBQM’ and the agenda will cover topics relevant to both Subject Matter Experts and RBQM Rookies alike. The fact that the online program is dedicated to all aspects of Risk-Based Study Planning and Execution is testament to the huge strides that the industry had made in the past 12 months in moving this game-changing topic from a nice-to-have to a must-have for Sponsors and CROs. We can’t wait to see the speakers in action and contribute to the discussions and debate.”
Both days will focus solely on RBQM and feature the industry’s leading innovators. Highlights include:
Day 1 – Thursday, May 20, 2021
- Powered by the Pandemic – How Pharma Has Succeeded and How It Will Continue to Embrace Operational Changes Facilitated by COVID-19.
Ken Getz, Professor of TUFTS CSDD, provides a compelling look at how the pandemic has transformed the drug development operating environment and where it will be post-pandemic.
- The Evolution from RBM to RBQM – How Far Have Risk-Based Approaches Come in 10 Years and Where Do We Go Next?
Jonathan Rowe, Head of R&D Quality and Risk Management, ZS Associates, provides a review of the cross-functional use cases for RBQM and the role of regulators and guidelines in driving change.
- RBQM Best Practice Defined by Leading Industry Working Groups.
A panel discussion led by an esteemed panel of luminaries from Clinical Trials Information Initiative (CTTI), Metrics Champion Consortium (MCC), and Association of Clinical Research Professionals (ACRO) who have driven guidance for the Industry.
Day 2 – Friday, May 21, 2021
- The Future of Clinical Trials is Now.
Sy Pretorius, Parexel’s President, Clinical Development and Chief Medical Officer, explores the impact of COVID-19 on adoption of digital applications, decentralized models and remote monitoring.
- Has RBQM Lived up to TransCelerate’s Expectations? Ask the Experts!
A panel discussion with the original founders of RBQM from TransCelerate who will give their views on the state of Risk-Based approaches and where the industry is seeing the biggest benefits.
- The Application of RBQM to Rare Disease and Small Trials.
Jacqueline Gough, Director, Central Monitoring, Alexion, will provide best practice for the use of Risk-Based Quality Management in small and rare disease trials.