The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites

Why Should You Attend:

Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development. In 2016, the ICH revised the E6 guidelines entitled “Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2).” to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.

In this webinar we will identify the changes impacting investigators, sites, Sponsors, CROs: responsibilities and roles and explain the impact of the revisions on clinical trials conduct and organizational practices. Also, during this webinar we will evaluate solutions/applicability/modifications of organizational SOPs, processes, procedures and staff training; and discuss opportunities for implementing the revised guideline.

Areas Covered in the Webinar:

The revised guidelines The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. This session will explore the changes to provide a better understanding of how they impact conduct of clinical trials and provide solutions for implementation.

• GCP E6 R2 Guideline explanation
• New items in definitions
• New sections on investigator responsibilities, including oversight
• New sponsor section on quality management, including risk assessment
• Monitoring plans defined and implemented
• Serious breaches
• Globalization
• The new section on computer validation and electronic records
• Risk-based Quality Management (RBQM)
• SOPs development and implementation
• Systematic approach in assessing organizational SOPs
• Approach on processes and practices
• Designing modifications to assist with implementation
• Standardization

Who Will Benefit:

• Directors of Clinical Operations
• Medical Affairs specialists and leaders of this division
• Project Managers
• Staff from Pharmaceutical/Device Companies or CROs involved with the management of clinical trials
• Project Team Leaders
• Regulatory Affairs
• QC/QA Specialists
• Research and Department
• Clinical Research Coordinators (CRCs)
• Clinical Research Associates
• Data Managers
• Biomedical product development
• Grant Administrators

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.

Topic Background:

The ICH revised E6 guidelines was issued to reflect on the current research landscape: increases in globalization, study complexity, and technological capabilities. This session will explore the changes and evaluate the impact on the conduct of clinical trials.

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