The New ICH GCP E6 R2 Addendum


The New ICH GCP E6 R2 Addendum is a course that covers topics such as:

  • Sponsor oversight requirements
  • More efficient approaches to the design of clinical trials
  • Risk-based approaches for setting up clinical trials
  • New methodologies and technologies used in clinical trials
  • Quality by design
  • Risk-based management
  • Risk-based monitoring including centralized monitoring
  • Quality systems in clinical trials and clinical studies
  • Monitoring plans
  • Additional considerations for CRO management
  • Risk identification, management and control
  • Quality systems – including critical process and data identification
  • Electronic document management – the Electronic Trial Master File (TMF)

The New ICH GCP E6 R2 Addendum is intended for:

  • Regulatory Affairs
  • Clinical Research/Clinical Operations
  • Vendor/CRO companies
  • Quality Assurance (GCP Auditors)
  • Pharmacovigilance
  • Regulatory Authorities and Study Sites including Investigator initiated studies involved in clinical trials
  • Document Management
  • Clinical Trial Supply
  • IT
  • Legal

Future Events

Past Events


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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