The course will ensure that delegates have a sound understanding of the regulations applying to a range of medical technology products including drug-device combinations, in vitro diagnostics and advanced therapy products (especially tissue engineered products).  Read more Read less

Delegates will learn to determine which regulatory framework applies and understand the principles of bringing products to market under the different frameworks. The module will focus upon European requirements and will emphasize the requirements for ‘borderline’ products, especially drug-device combinations.

At a glance

  • Dates
    • 20 - 22 Nov 2018
  • Duration3 days
  • LocationCranfield campus
  • Cost£1,800

Course structure

The course will be delivered in the form of a three-day residential workshop including lectures and practical sessions. Accompanying lecture notes, will be supplied and support the course throughout.

What you will learn

On completion of the three-day course delegates should be able to:

  • Critically evaluate factors that might be used to select a regulatory framework for a particular product (eg. as a cosmetic, a device or a medicine)
  • Critically analyse and apply the development of strategies for CE Marking medical devices incorporating medicinal products
  • Critically evaluate the principals that influence and determine the regulatory designation of borderline products
  • Describe the European regulatory framework for some important types of medical products
  • Advise on submission requirements for CE marking.

Core content

Topics covered by the course include:

  • Legal issues and precedents for the designation of borderline products
  • The European regulatory framework for medicinal products including medicinal products with device features
  • The process for, and issues with, CE Marking a medical device incorporating a medicinal product
  • The content and format of submissions for medical devices incorporating medicinal substances to European medicines agencies
  • Case study involving a medical device incorporating a medicinal product
  • The European regulatory framework for advanced therapy products with a focus on tissue engineered products
  • The European regulatory framework for IVDs
  • The European regulatory framework for cosmetics.

Who should attend

This course is suitable for regulatory affairs professionals.

Partnerships

The course has been developed in partnership with TOPRA (The Organisation for Professionals in Regulatory Affairs).

Speakers

Lectures 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. 

For further location and travel details

Location address

Cranfield University
College Road
Cranfield
Bedford 
MK43 0AL

How to apply

Read our Professional development (CPD) booking conditions.