The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at the clinical site level.
Why should you Attend:
Practical aspects of developing relevant Key Performance and Quality Indicators (KP-QIs) for Risk-Based Quality Management will be discussed.
Areas Covered in the Session:
Identify and manage risks of clinical trials
Perform Cause-Effect Anaylysis for identified risks and develop mitigation strategy
Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
Develop effective Corrective Action Preventive Action (CAPA) Plans
Who Will Benefit:
Clinical Quality Assurance Auditors
Clinical Quality and Compliance Professionals
Clinical Research Associates
Regulatory Affairs Professionals
Clinical Research Coordinators
Marina Malikova , Ph.D., MSci, MA, CCRA, RAC - Executive Director, Surgical Translational Research: Operations and Compliance.
Dr. Malikova has over fourteen years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
Event Fee: One Dial-in One Attendee Price: US$150.00
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