Final ICH E6 (R2) Guideline on Good Clinical Practices – Webinar Recording/Transcript
Final ICH E6 (R2) Guideline on Good Clinical Practices: The Real Impact of the Changes
Want to attend the live webinar on May 27? Click here to register.
The recent ICH GCP E6 (R2) addendum, which contains 26 significant changes, affects the conduct of your clinical trials. How will these changes impact your team, investigators sites, sponsors and clinical research organizations?
In this presentation, Marina Malikova, Ph.D., MSci, MA, CCRA, RAC, will cover these changes — new sections on investigator responsibilities, a new sponsor section on quality management, new section on computer validation and electronic records as well as updates on monitoring plans, risk-based quality management system and serious breaches — while providing solutions on how to build or update your organization’s SOPs, processes and practices. She’ll also share tips on how to modify your study designs.
- GCP E6 Guideline R2 Addendum overview and areas of changes, including new sections on investigator responsibilities and the substantial new sponsor section on quality management
- Implementation of revised regulatory guidelines, including those affecting globalization issues
- Introduction of risk-based quality management (RBQM), including those affecting serious breaches
- Development of SOPs, including those on validation and electronic records
Are you ready to implement new and up-to-date approaches to clinical trial design, conduct, oversight, recording and reporting?
Meet Your Presenter:
Marina Malikova, Ph.D., MSci, MA, CCRA, RAC, assistant professor of surgery, Boston University School of Medicine
Marina Malikova, Ph.D., MSci, MA, CCRA, RAC, is an assistant professor of surgery and executive director of surgical translational research, operations and compliance at Boston University School of Medicine. She has over 15 years of experience in the clinical research field and has managed Phase I–IV studies involving investigational drugs, devices and biologics. Dr. Malikova has worked on industry-sponsored and investigator-initiated trials in the fields of surgery, cancer diagnostics and interventional radiology.
Who Will Benefit:
- Directors of clinical operations
- Medical affairs specialists and leaders of clinical operations
- Project managers of clinical operations
- 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 development (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 personnel
- Quality control (QC) specialists and quality assurance specialists