This workshop is a core introduction to the foundation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) efficacy group.
The original version of E8 was adopted in Canada in 1998. The new edition was implemented in Canada in January 2022, with significant changes in four main areas. The new document accommodates a much wider range of both study designs and data sources that play a role in drug development. The approaches for optimizing study quality which promotes the reliability, efficiency and patient focus of clinical trials have also advanced.
In this session you will learn how to:
- Describe internationally agreed-upon principles and practices to facilitate regulatory acceptance
- Understand the elements of quality that are considered in the design and conduct of clinical studies, including identification of factors critical to the quality of the study and management of risks to the critical factors during study conduct
- Identify the types of clinical studies performed during the product lifecycle
- Be familiar with the ICH Efficacy Family of Guidelines used in the conduct of clinical studies