2018 - 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: support-AT-compliance4All.com