This short course is designed to help regulatory professionals understand the fundamentals of the clinical trial process, such that they then have a suitable working framework from which to develop specific interrogation of problems and the development of solutions, when dealing with clinical trial issues in relation to product development and registration strategy.
Our Module aims to enable delegates to understand when a clinical investigation is necessary, the regulatory processes involved and the alternative routes to demonstrate compliance to performance under essential requirements, as well as the safety and efficacy of the intended purpose of the technology, thereby enabling students to provide strategic regulatory advice on the clinical development programme.
- Types and designs of clinical studies
- Preclinical requirements
- Clinical evaluation and when to do a study
- Good clinical practice (ISO 14155)
- Clinical trial supplies and labelling
- Post market surveillance studies
- Health economics and device trials
Lectures will be delivered by a number of speakers from industry.
Three days including lectures and practical sessions
This course has been developed in partnership with TOPRA, The Organisation for Professionals in Regulatory Affairs. The course is also Module 3 of Medical Technology Regulatory Affairs MSc.