The revised guidelines are entitled “Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2).” The ICH steering committee comprised of representatives from the pharmaceutical industry and the regulatory bodies of the United States, Japan, the European Union (EU), Canada, and Switzerland.
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.
- GCP E6 R2 Guideline
- Risk-based Quality Management (RBQM)
- SOPs development and implementation, Standardization
- Directors of Clinical Operations
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Medical Affairs Specialists and Leaders of this Division
- Project Managers
- Grant Administrators