Press Release

Expert Speaker Lineup Revealed for Award Winning RBQM Event

King of Prussia, PA – August 1, 2023: CluePoints, the premier provider of Risk-Based Quality Management (RBQM) Software for clinical trials, has revealed the full agenda and speaker lineup for RBQMLive 2023.

RBQMLive 2023 is a free, virtual event for anyone working with, interested in, or planning to adopt risk-based approaches to clinical trial management and oversight. Taking place September 6 and 7, there is something for everyone interested in risk-based management of clinical trials – no matter the size of the organization or experience of the delegate. The educational RBQM event was also named as product of the year by the Business Intelligence Group at the 2023 Sales and Marketing Technology Awards in the Experiential/Event Marketing category.

Day one on September 6 will focus on The Global Transformation of RBQM. Keynote speaker Ken Getz, Executive Director and Professor at the Tufts Center for the Study of Drug Development, will share research findings on RBQM adoption from a recent global study and executive roundtable discussions.

Other day one highlights include:

  • The ABCs of ICH E6 (R3): Understanding the Guidance Updates with Dave Nickerson, Head of Clinical Quality Management at EMD Serono.
  • Mastering RBQM During the Design & Planning Phases Critical to Quality Factors with Jonathan Rowe, Principal – Head of R&D Quality, Operations & Risk Management at ZS Associates.

Day two on September 7, will focus on The RBQM Journey. The keynote will feature a panel discussion with Karen McCarthy Schau, Director, Adaptive Monitoring at Vertex, Lesley Lardino, Senior Director, Data Management at Astellas, and Cris McDavid, Associate Director, Clinical Operations, RBQM, at Parexel.

Other day two highlights include:

  • Recommendations on The Evolution of QTLs in Light of ICH E6(R3) – Recommendations from Industry Experts with Lukasz Bojarski, Executive Director of Centralized Monitoring & Risk-Based Quality Management at AstraZeneca, Linda Sullivan, Senior Fellow at Tufts Center for the Study of Drug Development, and Marion Wolfs, Global Head Risk Management & Central Monitoring, Janssen.
  • Understanding the RBQM Process & Documentation Phase Central Monitoring & Risk Based Study Execution with Neshad Sharma, Senior Manager, CD&O Support & Enhancement, Process Excellence at Bayer and Scott Litrakis, Executive Director, Clinical Compliance & Risk Management.

Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, commented, “RBQM is evolving to meet the needs of modern clinical trials and new global regulatory requirements. RBQMLive 2023, sponsored by CluePoints, is an opportunity to reflect on that progress and learn how you and your team can succeed with RBQM – whether you are first-time adopters or looking to build on existing processes. We urge everyone to register for the free sessions and gain insight from our fantastic line-up of expert speakers, all leaders in their respective fields.”

RBQMLive 2023, sponsored by CluePoints, takes place virtually from September 6 to 7. In addition to the presentations and panel discussions, RBQM Chat Cafés will be running on both days, giving attendees the opportunity to network with their peers and discuss best practice.

Visit for more information and to register.


About CluePoints

CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. Our products utilize comprehensive statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management, and drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation you now have everything you need to adhere with global regulatory guidance. The result is increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.


Media Contact

Jodie Dixon – Discovery PR, on behalf of CluePoints
Email:   [email protected]
Mobile:   +44 (0)7507 727721
Office:   +44 (0) 1606 889 194

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