The course is designed to help regulatory professionals understand the fundamentals of the clinical trial process. Read more Read less
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.
At a glance
- Please enquire for course dates
- Duration3 days
- LocationCranfield Campus
Course structureThe course will be delivered in the form of a three-day workshop including lectures and practical sessions. Accompanying lecture notes, will be supplied and support the course throughout.
What you will learn
The course aims to provide an understanding of 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 delegates to provide strategic regulatory advice on the clinical development programme.
Topics covered by the course include:
- 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.
Who should attendRegulatory affairs professionals wishing to develop their understanding of the fundamentals of the clinical trial process.
PartnershipsThe course has been developed in partnership with TOPRA (The Organisation for Professionals in Regulatory Affairs).
SpeakersLectures will be delivered by a number of speakers from industry.
Accommodation options and prices
This course is non-residential. If you would like to book accommodation on campus, please contact Mitchell Hall or Cranfield Management Development Centre directly. Further information about our on campus accommodation can be found here. Alternatively you may wish to make your own arrangements at a nearby hotel.
Location and travel
Cranfield University is situated in Bedfordshire close to the border with Buckinghamshire. The University is located almost midway between the towns of Bedford and Milton Keynes and is conveniently situated between junctions 13 and 14 of the M1.
London Luton, Stansted and Heathrow airports are 30, 90 and 90 minutes respectively by car, offering superb connections to and from just about anywhere in the world.
Read our Professional development (CPD) booking conditions.