Fundamentals of Risk Management in Clinical Research 2018

Overview:

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

Project Managers

Medical Monitors

Regulatory Affairs Professionals

Clinical Research Coordinators

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker Profile:

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.