Final ICH E6 (R2) Guideline on Good Clinical Practices
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.
- Explore current transparency requirements for study publication from the FDA, EMA and Health Canada
- Grasp the link between transparency, privacy and brand trust, and how privacy-preserving data-sharing methods can help sponsors earn trust with internal and external stakeholders, including patients themselves
- Understand new regulatory guidance, EMA Policy 0070 and Health Canada Public Release of Clinical Information, on how to anonymize clinical study reports
- Implement best practices for anonymization to enable trial transparency while protecting participant privacy, including quantitative re-identification risk measurement
- Preserve data utility and protect patients when sharing data voluntarily
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
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May 27, 2020
1 hour 31 minutes