2/23/2021
Sandra “SAM” Sather,
Vice President, Clinical Operations & Quality Initiatives, Clinical Pathways LLC
Topic for Speaking Engagement and Panel Discussion: Central and Remote Monitoring: Leveraging Central and Remote Monitoring in Risk-Based Quality Management
Topic for Panel Discussion: Medical Device Trial Regulations, Quality and Data Management: Navigating a Changing Regulatory Landscape and Accelerating Approvals
Dates: March 2 - 4, 2021
Location: The virtual summit consists of pre-recorded sessions with live panel discussions and live Q&A sessions.
Register: https://register.healthtech.com/reg/scope
Sandra “SAM” Sather is:
1. A speaker and panelist on the topic “Risk-Based Quality Management, Verb or Noun? Uncovering & Addressing the Gaps” March 4th at 10:10 am EST, with panel at 11:00 EST.
Description: Have you ever heard or stated, “We are not doing RBM for this study”? Even more complicated is when a CRO is involved, and a sponsor says, “we rely on the CRO’s RBQM." Per ICH E6, an RBQM approach should be part of a sponsor’s QMS. This session discusses these challenges, some potential root causes, and recommendations to support the relationships between stakeholders and how to support the quality of the trial with the model of adaption.
An organization’s quality system should support a risk-based approach to many clinical trial activities like site monitoring, data quality oversight, vendor oversight, safety surveillance, audit planning, and more. Sure, there is training on what risk management is and also what the specific process is for risk assessment, but what the team members who work directly with sites or project teams do not understand is that there are huge variations in how RBQM is being integrated and implemented from company to company. Sometimes this leads to some trials are “RBM” trials and some not “RBM” trials, like we turn on and off RBQM. Can we? This depends on if RBQM is in the context of a system integration or a project or study level service (verb – noun). Is this holding our team members back from developing critical thinking during project management, vendor oversight, and site monitoring with a risk mindset? The use of RBM at study start-up or vendor selection as a verb by one stakeholder and as a noun by the other stakeholder creates a false understanding that we have covered the RBQM “requirement” for a clinical trial. For example, the elevator speech by a CRO in a bid defense and the actual process application can be disconnected.
Attend SAM’s session to learn how to:
Identify the gaps in RBQM training and implementation,
Recognize the misuse of the term RBQM (RBM) and impact during study set-up of SOW and monitoring plan development,
Describe some ways to assess and address gaps.
2. A panelist in the: Challenges and Solutions in Medical Device Trials section of the summit to discuss Monitoring Approaches to Support RBQM March 4th at 11:00 am EST.
Description: “Cambridge Healthtech Institute’s 2nd Annual Medical Device Trial Regulations, Quality and Data Management conference will provide an in depth understanding of the new rules and regulations and how best to plan for impending deadlines, examine regulatory and data considerations for device combination product trials, and get lessons learned for operationalizing regulatory requirements.”
This conference has different tracks, and one is for medical device trials. Medical device clinical trials differ from drug studies due to regulatory and approval differences and multiple pathways and classifications. The EU MDR will go into effect May 2021, delayed a year due to the pandemic, but many device manufacturers or sponsors are still not prepared for the changes. Additionally, 2020 saw an update to medical device GCP standards with ISO 14155:2020. Designing and conducting a clinical trial should be done with Good Clinical Practice (GCP) and quality in mind to ensure the reliability of trial results as well as to follow requirements of regulatory authorities. Organizations usually understand the necessity of following ICH E6(R2) to ensure GCP; however, there is frequently a gap in training internal teams, contractors, CROs, and sites on ISO 14155:2020 GCP for medical devices. Following the standard is a key part of building globally recognized GCP into the full lifecycle of the medical device clinical trial and can complement the current GCP training.
You may also be interested in our Clinical Leader article “An ISO 14155:2020 Primer — Good Clinical Practice for Medical Device Trials” HERE.
Concerned your organization has a training gap related to medical device GCP or RBQM? Clinical Pathways offers an off-the-shelf Overview of ISO 14155:2020 eLearning to purchase (HERE).
Additionally, both Introduction to RBQM and Overview of ISO 14155:2020 are available as eLearning in our LMS, full SCORM package delivery compatible with your LMS, or fully customizable to your branding in ours or your LMS. We can develop an entire curriculum to meet your organization’s training needs, whether it is related to medical device, RBQM, or another focus.
Email us at info@clinicalpathwaysresearch.com for more information.
- The Clinical Pathways Team
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