- Global Pharma News & Resources
29-Oct-2020 - 29-Oct-2020

J35 GCP for Experts

  • Location:
    • Cedar Court
    • White Waltham
    • Maidenhead, Berkshire
    • SL6 3LW
    • England
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The Course

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.

Learning Objectives

• Outline recent major developments in Good Clinical Practice

• Discuss the purpose and impact of EU regulations on the conduct of clinical research

•Outline the proposed Clinical Trial Regulation

• Summarise other current issues that affect clinical trials

e.g. risk based monitoring

Course Outline

•  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  2008 •  Risk based Monitoring