GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

Course overview

Clinical research is a constantly evolving field and the regulatory requirements are frequently being updated. In order to stay ahead and maintain your GCP knowledge, it is important to receive regular training.

This must-attend course provides a review of recent changes to relevant legislation and guidance and will look at how these developments have been implemented. Topics covered will include the latest update of the EU Clinical Trial Regulation, the final EMA TMF guideline and the further renovation of ICH GCP R2. The programme will also examine 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 in the EU, UK and FDA considerations including Covid 19 for future studies
• Review the requirements of the TMF
• Identify common audit and inspection findings to help prepare for inspection
• Understand the EU Clinical Trial Regulation implementation
• Be updated on the ICH including ICH GCP R3 renovation
• Clarify requirements for data integrity
• Technology advances and GCP

Who should attend

The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance, QA, Audit, CROs, academic trialists and regulatory inspectors. 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.

Brief review of regulatory authority inspections findings

Hot inspection topics, including EMA, MHRA and FDA findings

EU Clinical Trial Regulation (536/2014) update

• Electronic EU clinical trial authorisation and the new CTIS
• Update on implementation
• Review of the key changes

Requirements of the EMA TMF from EMA GCP Inspectors Working Group

• TMF structure, content, security, control, managing correspondence and emails, scanning and certified copies, maintaining the TMF and storage, e-TMFs, archiving and retention
• The TMF plan – recommended format for compliance

Data Integrity guidance

• What inspectors look for in this
• MHRA integrity guidance

ICH update

• New European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
• ICH E8
• ICH GCP E6 R3 update

Awareness update from other EU, MHRA and FDA

EU

• EU Guidance on trials during Covid - pandemic-proof’ studies moving forward
• EMA guidance on validation & qualification of computerised systems
• ENpr-EMA Guideline: Assent / Informed Consent Guidance for Paediatric Clinical Trials

MHRA

• Brexit and running clinical trials in the UK

FDA

• Guidance for Industry, Investigators, and Institutional Review Boards: FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic
• FDA methods to obtain informed consent during Covid
• FDA Guidance on Enhancing the Diversity of clinical trial populations

Digitalisation and technology advances and GCP

• Technology innovations and drug development
• Electronic informed consent
• Apps, medical devices and mobile technologies in clinical trials
• Artificial intelligence
• Virtual clinical trials

Conclusion and final Q&A