How many “boutique conferences” for executives do you know? SCOPE Europe is definitely one of them. After the great success of its counter-event SCOPE US, the first European summit took place in Barcelona last October. Our Cyntegrity team was happy to be part of the conference in general and the Risk-based Monitoring (RBM) track in particular.
Zooming in on three key areas; analytics-driven feasibility, patient-centric enrolment planning and Risk-based Monitoring, SCOPE Europe professionally facilitated high level discussions between pharma industry leaders and decision makers.
Regarding the general roll-out of RBM strategies, we were excited to update ourselves on the current market developments and…..to observe progress:
- Top leading pharma companies, such as Amgen, Sanofi, GSK, Eli Lilly, seem to have embraced a risk-based approach. We found it a very encouraging signal seeing “big pharma” in the midst of RBM implementation and development initiatives.
- The RBM concept now seems to evolve into a broader Risk-based Quality Management (RBQM) scope, mainly driven by the ICH GCP E6 (R2) Addendum.
- Industry consortia, like the Metrics Champion Consortium (MCC), are aligning their activities as well by updating their frameworks, ensuring compliance with the latest regulatory guidance.
- A growing number of companies (finally) recognize that RBM is not an aspect nor a feature of Electronic Data Capture (EDC). They now understand that besides the EDC system, all other data recording systems including all relevant stakeholders and processes must be taken into account when adopting a holistic risk-based approach.
- As a result of these changes, we observed that top management is getting aware of the importance of “Critical Process, Critical Data, and (!) Critical Thinking” being prerequisite to initiating a successful RBM implementation in their organizations.
- Following the Life Sciences industry and sparked by the upcoming Medical Device Regulations (EU MDR), the Medical Device industry is also picking up on modern risk-based QM approaches including the design and development of its own implementation roadmap.
