What's On?
Day One
Thursday, May 20, 2021
Day Two
Friday, May 21, 2021
8:30-9:30 AM EDT
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.
9:30-10:15 AM EDT
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.
10:15-11:00 AM EDT
Critical Processes, Critical Data and Critical Thinking. An RBQM Implementation Journey
Nick May, Parexel's Risk-Based Monitoring Strategic Lead, takes a closer look at industry progress towards holistic oversight, requirements for effective implementation and lessons from early adoption.
11:00-11:45 AM EDT
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 trials.
11:45 AM-12:45 PM EDT
Panel Discussion
RBQM Best Practice Defined by Leading Industry Working Groups
For this panel discussion, we will hear from 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.
8:30-9:30 AM EDT
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.
9:30-10:15 AM EDT
Paving the Way for Centralized Monitoring Success at Pfizer
Lynne Cesario, Global RBM Program Lead, Pfizer, will provide a large Pharma perspective on utilising centralized monitoring to drive efficiency, enhance patient safety, and reduce study timelines.
10:15-11:00 AM EDT
Panel Discussion
Applying the Principles of RBQM to Data Management
CluePoints' Chief Scientific Officer, Steve Young, and Patrick Nadolny, Global Head, Clinical Data Management, Sanofi, will provide a large Pharma perspective on the value of risk-based approaches in the domain of clinical data management.
11:00-11:45 AM EDT
2030: An RBQM Odyssey - RBQM in Clinical Trials of the Future
Lukasz Bojarski, Head of Centralized Monitoring, AstraZeneca takes a look at emerging trends in delivery of clinical trials (decentralization, digitalization and reduced patient burden) will be discussed to paint the picture of industry’s landscape in 2030 and analyse the evolution of RBQM methodology.
11:45 AM -12:45 PM EDT
Panel Discussion
Has RBQM Lived up to TransCelerate's Expectations? Ask the Experts!
For this panel discussion, the founders of RBQM from TransCelerate give their views on the state of Risk-Based approaches and where the industry is seeing the biggest benefits.