Enterprise Process Best Practices & Lessons Learned
Regulators have been vocal about the need to improve quality in clinical trials, patient safety as well as the effectiveness of monitoring through Quality by Design (QbD) and Risk-Based Monitoring (RBM), and have provided guidance to that end as well.
With industry interest on the rise, the need remains urgent to design and deliver actual RBM solutions that will transform risks into returns.
In this webinar, Covance’s lead RBM expert shares key experiences gathered during a five-year, cross-functional journey designing and implementing Covance’s enterprise RBM process.
The Webinar demonstrates a holistic, flexible RBM approach designed with the end in mind: delivering a robust set of results that form part of a submission dossier, delivered efficiently and eliminating errors that matter.
Michael Walega,
Business Lead, Risk-Based Monitoring, Executive Director, Transformation Programs, Clinical Development Services, Covance Inc.
Mr. Walega is a qualified Biostatistician and a Six Sigma Master Black Belt. He previously led the Biostatistics and Programming groups, and the Process Excellence team at Covance.
Mike joined the Covance Risk-Based Monitoring initiative in 2011 and now serves as Business Lead, directing the core project team.
- Discuss how to design RBM with the end in mind: a quality trial and data to satisfy regulators
- Explore predictive, proactive and preventative approaches to risk
- Review lessons learned through live implementations of RBM
- Understand the ROI and value of RBM in clinical trials
- Pharmaceutical and Biotech Executives in Project Management
- Operations
- Research & Development Regulatory
- Procurement
- Clinical Safety and Pharmacovigilance positions (manager/director/VP)
