Data Integrity in GCP

Almost 2 years after we hosted our first Data Integrity in GCP Webinar, many things have changed with regards to regulatory expectations for the design and conduct of clinical trials while others remain as before. The latest revision to ICH E6 (R3) has highlighted the importance of following risk-based approaches to the conduct of the trial and along with the finalized EMA guidance on computerized systems has brought forward the importance of data integrity, data governance and computer system validation.

Join on February 29th to discuss:
- important GCP updates
-requirements for systems, security and validation
-requirements for data integrity and data governance
-regulatory expectations for sponsor responsibilities and vendor oversight

As always, we are going to walk you through recent case studies to explore what can go wrong in clinical trials in case of incompliance and review important lessons to be learnt from past wrong-doings.