Keith in Public

Keith is an accomplished presenter and speaks regularly at conferences on a wide range of topics in clinical trials. To quote from a recent attendee to one of his presentations: Keith “is extremely knowledgeable about RBQM. His presentation on ICH E6(R3) made me smile. Lots of people would have made a dull presentation out of a potentially dry subject. Not Keith. No one else could have got away with using ‘Chicken Lickin’, the children’s story, to make a point about R3. Keith also made some interesting comments about the language in the latest draft. He clearly doesn’t like ‘Hazard’ as a term. According to the timelines in Keith’s presentation, R3 could be adopted in October this year. Just in time for SCOPE Europe. Keith spoke at last year’s event. I wonder what children’s fable he’ll use to make his points next time 🙂” – Neil Watkins, TRI

For information on publications, see here.

Options for training and workshops are on the Training page.

Upcoming public speaking:

mindsON RBQM (Cyntegrity): Series with an interactive session every month. Started in January 2022 and now extended into 2024 and run in different timezones due to demand. Focusing on practical aspects of Risk-Based Quality Management in ICH E6 R2 section 5.0 and Quality by Design in ICH E8 R1 with examples. Run jointly with Johann Proeve.

Key Performance Indicators (KPIs) and Metrics:

• SCOPE Florida. Feb 2024: Panel Discussion on KPIs – follow-up to last year’s very popular session. Moderated by Yusuf Ghadiali, Daiichi Sankyo.

• SCOPE Florida. 8-Feb-2023: “PANEL DISCUSSION: Approaches and Best Practices for Assessing CRO Performance” moderated by Yusuf Ghadiali, Daiichi Sankyo
• SCOPE Florida. 8-Feb-2023: “Building a Relationship Health Program and the Impact on Partnerships” with Dennis Saolotti, Jazz Pharmaceuticals
• SCOPE Europe. 3-Oct-2022: “KPIs Are Used for Oversight – But Can They Monitor Risks Too?” with Steve Crow, Jazz Pharmaceuticals. And Panel Discussion on “The Place of Quality Tolerance Limits in a Changing Regulatory Environment”
• SCOPE 2022. 9-Feb-2022: “Helping QTLs To Do What We Want – Detect Emerging Issues Early”
• WCG Avoca Quality & Innovation Summit. 25-May-2022: “The Hidden Challenges of Metric Reporting” with Linda Sullivan
• Applied Clinical Trials Webcast. 24-May-2022: “Is Oversight a Burden or Pivotal to Operational Efficiency?” with Steve Crow (Jazz Pharmaceuticals) and Elvin Thalund (Oracle)
• WCG-Avoca Quality Consortium Jon Lee Webinar “Defining Metrics That Matter” with Linda Sullivan. 16 Dec 2021
• MCC vSummit. 28-30 Sep 2021: Presentation and Discussion Group – “Selection, Implementation and Use of KPIs in a Sponsor-CRO Collaboration”
• SCOPE 2021. 2-4 Mar 2021: Determining the Right Metrics to Monitor and Develop a Sponsor-CRO Collaboration – Joint presentation with Steve Crow, GW Pharmaceuticals
• MCC Clinical Trial Risk and Performance Management Virtual Summit. 8-10 Sept 2020: “Case Study – Determining the Right Metrics to Monitor and Develop a Sponsor-CRO Collaboration” with Steve Crow, GW Pharmaceuticals. Also co-host of the Summit.
• SCOPE, Florida. 21 Feb 2020: “Defining Metrics for Quality Vendor Oversight” – representing the MCC
• MCC Clinical Trial Risk and Performance Management Summit, Philadelphia. 4-5 Sept 2019: “Secrets to Implementing Successful Metrics Programs” and chair of the Risk-Based Quality Management Track
• Interview on TMF Metrics in a podcast by LMK Clinical Research Consulting, March 2018

Risk-Based Quality Management (RQBM) and Quality by Design (QbD):

• SCOPE Florida. Feb 2024: “Proposed ICH E6 Updates to Quality Management – Will They Help or Hinder?”

• SCOPE Europe 17-18 Oct 2023. Moderator for the panel discussion “Change Management: The People Component can Make or Break your RBQM Program!” Panelist on “RBQM for Decentralized and Hybrid Clinical Trials” and presentation “Root cause analysis isn’t just for issues! How RCA fits into good risk control as part of your RBQM strategy”

• SCOPE Europe. 21 Apr 2022: “The Monitoring Process Changed: How Do You Know It’s Working?”
• SCOPE 2022. 9 Feb 2022: “Helping QTLs to Do What We Want – Detect Emerging Issues Early”
• MCC Podcast Nov 2020: Implementing the Successful Total Cost of Quality Model in Clinical Trials
• SCOPE Europe 11 Nov 2020: How can Cost of Quality help us implement Quality by Design (ICH E8 R1)? Representing the MCC.
• Clinical Trials Europe, Barcelona. 21 Nov 2019: “The impact of risk-based quality management on vendor oversight” – representing the MCC
• Institute of Clinical Research “Risky Business” Workshop. 20 Sept 2019: “Risk Evaluation and Control – Meeting the Requirements of ICH E6 (R2).
  A worked example.”
• European Clinical Trials Inspection Readiness Summit 17th May 2019: “Bridging the gap between CAPA and Quality Risk Management to prevent systemic-level issues.” Representing the MCC.
• Clinical Trial Risk and Performance Management Summit (MCC) in Princeton,NJ, USA: “Getting to the root of the problem – there must be a better way!” November 2018. And as a panelist discussing critical thinking
• Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2) – An MCC Webinar. October 2018. With 200 participants.
• SCOPE Europe, Barcelona, October 2018: “The Risk Assessment is Done: Now What?  Setting up Centralized Monitoring and Addressing the Gap in Critical Thinking” Representing the MCC.
• Institute of Clinical Research Project Management Forum, UK, October 2018: “Risk Assessment in the era of ICH E6 (R2): Building on the TransCelerate Risk Assessment and Categorization Tool (RACT)” Representing the MCC.
• “The Risk Assessment is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan” DIA USA 2018.
• Applied Clinical Trial Webcast: “Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?” on September 2017
• The Evolving Area of Central Monitoring: What is it? What Data is Being Reviewed? Who is Responsible? DIA, USA 2017
• Poster Presentation “The importance of measuring TMF Health for continuous inspection readiness” DIA, USA 2017
• Meeting requirement 5.20 of ICH E6 (R2) for root cause analysis, Institute of Clinical Research, UK 2017