CluePoints announces full agenda and speakers for free RBQM event next month

04-Aug-2023 - Last updated on 04-Aug-2023 at 09:10 GMT

Risk-based quality management (RBQM) is used to identify and assess risks then finding ways to manage them and is an important part of clincal trials.

Anything that could be a potential risk to the quality of a trial – at every stage of the study from start to finish – should be picked up by using RBQM strategies.

CluePoints provides RBQM software for clinical trials and has just revealed its full agenda and speaker line-up for its award-winning RBQMLive2023 event.

The event is a free, virtual event for anyone working with, interested in or planning to adopt risk-based approaches to clinical trial management and oversight. It takes place on September 6 and 7.

The educational RBQM event was 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.

Patrick Hughes, co-founder and chief commercial officer of CluePoints said: “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.”

The first day will focus on the global transformation of RQBM with keynote speaker Ken Getz who is executive director and professor at the Tufts Center for the Study of Drug Development. He will share findings on RBQM adoption from a recent study and roundtable discussions.

Also on day one, head of clinical quality management at EMD Serono, Dave Nickerson will present the ABCs of International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline now that the updated version R3 (ICH E6 (R3))

Jonathan Rowe, principal at ZS Associates will discuss mastering RBQM during the design and planning phases critical to quality factors.

Day two 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.

Recommendations on The Evolution of QTLs in Light of ICH E6(R3) – Recommendations from Industry Experts. Speakers include Lukasz Bojarski, executive director of centralized monitoring and RBQM at AstraZeneca, Linda Sullivan, senior fellow at Tufts Center and Marion Wolfs, global head risk management and central monitoring, Janssen.

Understanding the RBQM Process & Documentation Phase Central Monitoring and Risk Based Study Execution with Neshad Sharma, senior manager, CD&O support and enhancement, process excellence at Bayer and Scott Litrakis, executive director, clinical compliance and risk management at Bristol-Myer Squibb.