This training session compares the differences in the regulatory requirements when running clinical trials versus non-interventional studies (NIS) in the EU.

Topics covered:

• Regulation of Clinical Trials in the EU
• Introduction to the ethical foundation of clinical research
  • Nuremberg Code – Permissible Medical Experiments
  • Declaration of Helsinki- Ethical Principles for Medical Research Involving Human Subjects
  • ICH GCP – Guidelines for Good Clinical Practice
  • Why is ICH GCP Universally Accepted and Complied with in the Context of Clinical Trials?
• EU Clinical Trials Regulation
  • Clinical Trials Information System (CTIS)
  • Clinical Trials Approvals
  • Applicability of the EU Clinical Trials Regulation
  • Regulatory Definitions
  • Clinical Study Decision Tree
• Regulation of Clinical Trials in the EU – Summary
  • Regulatory Framework for NIS
  • Clinical Study Decision Tree
  • NIS Approval Requirements for France
  • NIS Approval Requirements for Germany
  • When You Understand the Ethical Foundations for NIS…You Begin to See the Trends
• Regulation of Non-Interventional Studies in the EU – Summary
• Conclusions

What you get with your subscription:

• Narrated training session
• PDF of the training slides
• PDF of the training slide notes
• Personal account from Eva Mozes Kor