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This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. It also explores the impact of EU data protection laws on clinical research and summarises other current issues that affect clinical trials.
Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook
• Describe the purpose of Good Clinical Practice (GCP)
• Outline the significant milestones in the history of GCP development
• Review the respective responsibilities of Sponsors, Investigators and Ethics Committees in the context of GCP
• State the purpose of the EU Clinical Trial & GCP Directives
• Outline the scope of the Directives
• Review implications of the Clinical Trial Regulation
• Discuss some of the implications of the Directives for clinical researchers
• Describe some practical applications of GCP
• The need for ethics & regulation
• Roles & responsibilities in Clinical Research
• EU Clinical Trials directive
• EudraCT database
• UK legislation
• The EU Regulation proposals
• Clinical trials authorisations
• Voluntary harmonisation procedure
• Substantial amendments
• IMPs & NIMPs
• HMA Strategies
• Informed consent
• GMP Annex 13
• Pharmacovigilance reporting
• Advanced therapy regulations
• Inspections
• Declaration of Helsinki 2013
• Risk based Monitoring