10

THIS COURSE WILL TAKE PLACE ONLINE VIA ZOOM

This full-day course provides an in-depth look at the regulatory systems currently in operation in the US and EU and their impact on the conduct of clinical research. The course explains in detail the practical applications of GCP such as risk management, and outlines recent and planned major developments in GCP. It also explores the impact of EU data protection laws on clinical research and provides insight into regulatory inspection approaches as well as “hot topics”.

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook. 

•         Outline recent and planned major developments in Good Clinical Practice

•         Define impact of US and EU regulatory requirements on the conduct of clinical research

•         Discuss current issues that affect clinical trials such as sponsor oversight and risk management

·       Develop methodologies to prepare efficiently for implementing changes

• US Clinical Trial Regulations
• Declaration of Helsinki
• The Belmont Report
• ICH, including E6, E8, E27 …. and “Renovations”
• The EU Clinical Trial Regulation
• EU Clinical Trials Directives
• UK Clinical Trial legislation
• Voluntary harmonisation procedure
• Data Protection
• GMP Annex 13
• Substantial amendments
• IMPs, NIMPs & auxiliary products
• Inspections and “Hot Topics”