Course Details

One day classroom course with a mix of presentations and workshop sessions

Clinical Research is a constantly evolving field and the regulatory requirements change frequently.  In order to stay up to date and maintain your GCP knowledge it is important to receive regular refresher and update training.  This course provides a refresher on GCP requirements, an update on recent changes to relevant legislation and guidance and an indication of future changes planned.  The course is designed to:

• Refresh knowledge of current guidance and legislation
• Provide an update on recent changes and their implications for trial conduct
• Facilitate discussion with colleagues in the field to learn from others’ experiences
• Raise awareness of future changes planned.

Anyone working in clinical research with existing knowledge of GCP requirements who needs an update course for operational or regulatory reasons.  For example:

• CRAs, CTAs and Project Managers
• Clinical Trials Supplies Staff
• Medical Advisers
• Data Managers
• Investigators
• Study Nurses

Refresher and update on ICH

• ICH GCP Refresher
• ICH GCP Addendum – key changes and implications

European Clinical Research

• Summary of Current Legislation and Guidance with emphasis on recent additions
• New EU Legislation – current status and hot topics
• New and updated Guidance documents supporting EU Clinical Trials Regulation

UK Clinical Research 

• Refresher on UK Legislation
• MHRA Grey Guide – overview and hot topics
• Approvals in the UK

FDA Update

• New Guidances – overview and implications