GCP and Clinical Research Update - Hot Inspection Topics
Clinical research is a constantly evolving field and the regulatory requirements are regularly being updated. In order to stay up to date and maintain your GCP knowledge, it is important to receive regular training.
This course provides an update on recent changes to relevant legislation and guidance and will discuss how these changes have been implemented. Topics covered will include ICH GCP R2, the EU Clinical Trial Regulation, data integrity and the impact of GDPR on clinical trials. The programme will discuss inspection findings and common failings in these new areas and how these should be addressed.
This is a highly interactive course suitable for those who need to refresh their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors.
Benefits of attending:
- Discuss recent developments in GCP and clinical trial legislation and guidance
- Identify common audit and inspection findings and discuss how to prevent these occurring
- Understand the impact on clinical trials of recent GCP principles and regulatory standards such as the EU Clinical Trial Regulation (536/2014) and GDPR (2016/679)
- Clarify requirements for clinical QMS and QTLs (quality tolerance limits)
Who should attend
The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance It will also be of interest to those departments who liaise/ support clinical trial personnel and all other professionals who want to know more about updates in GCP regulations and guidelines covering clinical trials.