The past decade Quality Risk Management or Risk-Based Quality Management (RBQM) has taken flight in clinical research. Initially approached with some hesitation, RBQM is nowadays embraced by both regulators and the industry, to build and control quality in clinical studies.

RBQM had already been mentioned in revision 2 of ICH E6 Good Clinical Practice. However, in the more recent revision 1 of ICH E8, General Considerations for Clinical Trials, the regulators make crystal clear that they expect quality into the study design, an open organizational culture where critical thinking will be encouraged, and a focus on critical thinking to quality factors in the execution of clinical studies. (The draft version of) Revision 3 of ICH GCP E6 can be expected any moment and will most likely follow the same line.

In other words, the right moment for the DARQA GCP committee to organize a day about Risk-Based Quality Management. We will be looking at the basics of RBQM, in presentations and workshops, experts will share examples of how RBQM can be applied in practice and there will be sufficient room for questions.

Programme
09.30 – 10.00 Welcome with coffee/tea
10.00 – 10.15 Introduction – Eveline Krijger (Chair of the GCP committee)
10.15 – 10.30 Poll: Do we already make use of RBQM? – Henrieke de Bie (Principal Owner/Consultant at Beyond Compliance)
10.30 – 11.15 Revision of ICH Guidelines E8 and E6: A great leap forwards in thinking “first time right” - Henrieke de Bie
11.15 – 12.30 The basics of RBQM in clinical studies – Mihaela Nosca (Director Clinical Compliance and Inspection Readiness at CSL Seqirus)
                         - Set-up of RBQM in studies and quality systems / organisations
                         - Critical to quality factors and quality tolerance limits
                         - Preparation for this afternoon’s RBQM workshop
12.30 – 13.30 Lunch
13.30 – 14.00 Kahoot and brief Q&A – Henrieke de Bie
14.00 – 15.30 RBQM Workshop - Quality by Design, Risk Assessment and Risk-based monitoring
                         Richard Oonk (Senior Solutions Architect Risk Based Quality Management at Parexel; supported by Mihaela Nosca and Henrieke de Bie)
15.30 – 15.45 Break
15.45 – 16.45 How to apply RBQM in different organizations?
                         - Two examples: mid size pharma (Mihaela Nosca) and CRO (Richard Oonk)
                         - Open discussion and Q&A – (how) can we apply RBQM in e.g., start-ups, a hybrid outsourcing model, a small CRO, …
16.45 – 17.00 Closure
17.00 – 18.00 Drinks

Attendancy
DARQA members can attend for free.

Non-DARQA-members can attend this event after having paid a fee of € 100,- to DARQA’s bank account number NL 61 ABNA 0245 9984 46 providing the name of the attendee and GCP090623. The payment must be received by DARQA by Wednesday 7 June 2023 at the latest.
Non-DARQA-members who’d like to receive a payment invoice can request this from the DARQA treasurer by sending an email to This email address is being protected from spambots. You need JavaScript enabled to view it..

Names of the attendees will be visible to the other attendees.