Good Clinical Practices: Practical Applications and Implementation, Audit Preparation

Why Should You Attend:

Risk-based principles and quality management systems are the new reality of clinical auditing. Building on foundation of traditional auditing techniques, auditors must now expand and adapt their skills to be effective in this new environment. As risk-based monitoring continues to increase along with the development of quality risk management, the need for integration of these two concepts becomes apparent. Practical aspects of developing performance/quality indicators will be discussed.

This webinar will provide an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk.

Areas Covered in the Webinar:

• Define key GCP elements
• Identify the universal components of GCP
• Explain the differences between the legal and procedural elements of GCP
• Recognize key differences in GCP for drug, device, and biologics
• Describe the overlap between GCP, GLP and GMP
• Risk-Based Auditing: Applying risk assessment and management principles to clinical quality assurance
• Describe the key principles of Six Sigma for process improvement and Quality by Design (QbD)
• Develop relevant metrics as quality and key risk indicators (KRIs) for Risk-Based Quality Management (RBQM) systems to proactively identify and mitigate risk
• Quality Management Systems: Program design and implementation
• Describe the elements of a functional quality system
• Develop and implement site-specific approaches for corrective action of non-compliance
• Examine recent trends in non-compliance
• Regulatory Trends: Review of recent FDA findings for Sponsors, CROs, Monitors, IRBs, and Sites
• Auditing Clinical Research Organizations (CROs) through Qualification, Selection, and Ongoing Oversight
• Auditing Technology Providers, Site Management Organizations (SMOs), and Other Partners
• Responding to Audit Observations with your third party vendor
• Achieving "GCP Inspection Readiness": Preparation, Process, and Ongoing Preparedness
• GCP Compliance with Standard Operating Procedures (SOPs): Development, Implementation, and Management
• Ensuring site compliance and managing noncompliance, including Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) for sites
• Performing mock audits to identify strengths and address weaknesses
• Auditing sites for fraud, bioethics, or serious noncompliance

Who Will Benefit:

• Clinical Quality Control/Assurance Professionals
• Compliance Managers
• Clinical Research Associates
• Project Managers
• Investigators
• Study Coordinators
• Regulatory Affairs Professionals

Marina Malikova
Executive Director, Boston University School of Medicine

Marina Malikova, Ph.D., MSci, MA, CCRA, RAC - Executive Director, Surgical Translational Research: Operations and Compliance.

Dr. Malikova has over 20 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.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

Dr. Malikova has 10 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.

She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine since Summer, 2012.

Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology (ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.

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