Drug/Device and Device/Drug Combinations in the EU and USA Seminar


LRQA will be taking part in Drug/Device and Device/Drug Combinations in the EU and USA seminar on 21-22 April 2015 in London

In recent years, technical developments have found their way into medical practice and we have seen a trend towards the combined development of drugs, devices and in vitro diagnostics. 

This seminar is organised by the Management Forum and will provide practical advice on borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow. 

The event is suitable for anyone in the medical device, pharmaceutical and diagnostic industries, who are interested in medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system. This is your chance to hear from industry experts as they share their experience and advice, as well as an opportunity to network with people from all areas of the medical sector. 

Theresa Jeary, LRQA’s Technical Manager for Medical Devices, will be presenting on the following topics at the event: 

21 April 2015 

12.20 - Notified Body Expectations for Drug/Device Products

  • Devices containing ancillary medicinal substance
  • Devices containing ancillary human blood derivative
  • Post CE Marking expectations and changes 

14.00 - Defining the Regulatory Approval Route for Your Product

  • Product Classification
  • Differences between Device containing ancillary medicinal substances and medicinal products