Two years ago the European Medicines Agency adopted the E6R2 guidelines for good clinical practice, reflecting a changing culture of risk-based quality management (RBQM) in the pharmaceutical industry.
TORONTO (PRWEB) May 22, 2019
Two years ago the European Medicines Agency adopted the E6R2 guidelines for good clinical practice, reflecting a changing culture of risk-based quality management (RBQM) in the pharmaceutical industry. Both new and established pharma companies face challenges in implementing these guidelines into their existing clinical trial portfolios. Cloud-based technology offers several advantages to ensuring companies are compliant with those guidelines:
- Capacity to share Quality Tolerance Limits data with sponsors and vendors to ensure risks are regularly updated, prioritized and reported
- Engages clinical study teams, vendors and governance in maintaining and reviewing risks throughout the duration of the study
- Capacity to couple with Change and Project Management techniques
- Managing the change in culture required for risk-based quality management
- Real life lessons learned from implementation of E6R2 (Case Studies)
- Clarification of definitions around risk-based quality management
- How technology can be used to improve engagement and effective reporting
As well, the speakers will discuss the journeys of two pharma companies in implementing RBQM (challenges faced, lessons learned, etc.)
For more information or to register for this event, visit Implementing Risk-Based Quality Management (RBQM) – Lessons Learned and Key Pathways to Compliance.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.