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Course Introduction

Introduction

The course provides an introduction to Good Clinical Practice and is made up of six learning modules. The course covers the history of Good Clinical Practice, ICH GCP Guidelines, Sponsor and Investigator responsibilities, the EU Clinical Trial Directives and the Declaration of Helsinki.

Course Key Points

The course includes:

  • The origins of current legislative models and ethical guidelines by exploring significant events in the history of clinical experimentation
  • An overview of the sections of ICH GCP relating to the requirements for clinical trials in respect of Sponsors and Investigators
  • An overview of the EU Clinical Trials Directives and understanding the relevance of the Declaration of Helsinki to clinical research today through an understanding of its history and development

Course Author

Barney Horne, Global Head QA Auditing, Novartis Pharma AG, Basel, is a member of the RQA GCP Committee. He previously worked for PPD Global, Cambridge, UK as Executive Director, Quality Assurance and before that at Janssen Pharmaceutica in Belgium as QA Director and in various clinical development roles with AstraZeneca in the UK. Barney is also a Member of the Royal Pharmaceutical Society and the Institute of Clinical Research. He has served on conference programme committees for RQA and SQA, has organised GCP specialist meetings and regularly presents at regional and international meetings and conferences.

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