Compliance with ICH GCP R2 Addendum for Auditors 2017

Topics

• The future ICH major revision and expansion of ICH GCP planned for 2019
• The new requirements of the updated ICH GCP R2 guideline for auditors
• New requirements for what auditors should look for
• The challenges and opportunities in implementing the new guidance for auditors
• Best practice of these additional new GCP requirements for auditors

Who should Attend

• Clinical Operations Personnel
• Clinical Development Managers and Personnel
• Clinical Research Archiving and Document Management Personnel
• Clinical Research Associates
• CROs using Laboratories to Analyze Clinical Trial Samples
• Quality Assurance Managers and Auditors
• Sponsors and Non-Commercial Sponsors
• Project Management
• Laboratories Analyzing samples from Clinical Trials
• Consultants
• Legal and Regulatory Authorities
• Regulatory Affairs Personnel