The Impact of Final ICH GCP E6 R2
Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites
- GCP E6 R2 Guideline,
- Risk-based Quality Management (RBQM),
- SOPs development and implementation, Standardization
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.
- Directors of Clinical Operations
- Medical Affairs specialists and leaders of this division
- Project Managers
- Staff from Pharmaceutical/Device Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
- New clinical or other Project Team Leaders who will be managing projects
- Clinical, Regulatory, Research and Department (R&D) Staff who will design clinical trial programs
- Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs), Data Managers or others working in biomedical product development and/or interested in transitioning into clinical trials field
- Grant Administrators
- Regulatory Affairs
- Quality Control(QC), Quality Assurance Specialists
Fear, uncertainty and doubt (FUD) liner for the marketing purpose
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
Dr. Malikova has over 15 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products. 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 has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and dual board certified in Regulatory Affairs (RAC) for pharmaceutical products and medical devices by Regulatory Affairs Professionals Society (RAPS).
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