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ICH E8(R1) - General Considerations for Clinical Studies workshop
The original version of E8 was adopted in Canada in 1998. The new editon was implemented in Canada in January 2022. There are 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 advanced. We are much more apt at identifying the factors that are critical to the quality of a clinical study, ensuring that risks at all levels are proportionate while protecting human subjects and ensuring the reliability of study results. This presentation is a core introduction to the foundation of the ICH efficacy group. (1.5-hour lecture).

Learning Objectives
The learner will be able 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
• 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.

Nov 23, 2022 01:00 PM in Vancouver

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