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

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.

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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]