This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been  implemented  for sponsors, CROs/vendors and study sites. This will enable you to meet the new international GCP standard to ensure regulatory compliance and  the acceptance of clinical trial data by the regulatory authorities internationally.

Course Objective:

With the new ICH GCP E6 Revision 2 Addendum now finalised the changes should have been implemented for organisations running clinical trials.

The new guideline includes a number of “hot” GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials.

Why Should You Attend:

• Understand the new requirements of the updated ICH GCP R2 guideline
• Ensure  best practice with implementing the new requirements
• Review the new requirements for Sponsor and Investigator Oversight
• Understand requirements for CROs, quality systems,
• Explore risk based approaches for clinical trials
• Consider changes for the TMF
• Review best practice of these additional new ICH GCP R2 requirements

Course Outline:

• Understand the new requirements of the updated ICH GCP  R2 Addendum guideline
• Consider how to  ensure compliance of the ICH GCP R2 requirement to be prepared fro regulatory inspection
• Review the new requirements for Sponsor Oversight, CROs, quality systems, risk based approaches and the TMF
• Hear best practice for implementing these additional new  ICH GCP R2 requirements

Key Areas Covered:

• Implications of New definitions or enhancements to existing glossary terms
• Understand the requirements for quality systems with a risk based approach
• Consider how information should be recorded, handled and stored and compliance with data integrity expectations of inspectors
• Review Clinical investigators’ qualification requirements, supervision responsibilities, record keeping and reporting
• An increased focus on risk-based monitoring
• CAPA requirements
• Ensuring vendor oversight meets the expectations of inspectors
• And much more.

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

The session is relevant for professionals working in clinical research/clinical operations

• Medical Affairs Officers
• Director of Clinical Operations
• Regulatory Affairs Professionals
• Director of Publications
• Director of Clinical Trial Regulatory Management
• Clinical Trial Information Disclosure Directors
• Global Clinical Safety and Pharmacovigilance Officers
• Compliance Staff
• Clinical Quality Auditors
• Quality Assurance Personnel
• Document management
• CRO,
• Regulatory authorities
• Study sites including investigator initiated studies involved in clinical trials.
• It will also be of interest to those departments who liaise/support clinical trial personnel (such as clinical trial supply, quality assurance, document management, legal, and all other professionals who want to know more about the new ICH GCP (R2) guideline.