CRED Drug-Device Combination Products

CRED Drug-Device Combination Products
There are exciting developments in combining medical device technology with medicinal products, this is increasingly in focus due to biotechnology and advanced therapy medicinal products.

 
When: 7th September 2017
Where: Radisson Blu Hotel, Malmö, Sweden, SE211-25
(As well as flights to Malmö, another option is a 30 min train journey from Copenhagen Airport across the Oresund bridge, approx. €15.)


What is it?
This course will cover the following areas:
  • Current regulatory requirements for products that combine medicines and medical device, in EU and US; initiatives to develop guidance documents and good practice guidelines
  • Challenges of borderline products, where primary mode of action and thus classification is not clear.
  • Data requirements on the device component for combination medicinal products for successful Marketing Authorisation Application
  • Medical devices that incorporate ancillary medicinal substances or human blood product derivatives – what is considered ancillary action?
  • Impact of the new Medical Device Regulation on requirements for both medical devices and medicinal products
  • Advanced (cell) therapy products combined with medical devices – developments and regulatory requirements

TOPRA in Sweden event

This event will be followed by a TOPRA in Sweden event, which will start after the course and close at 8.00pm. This event will focus on the use of software to create smarter medicines and the requirements on such apps as medical devices:
  • Novel device technology
  • Behavioural science and patient profiling 
  • Disease and treatment information 
  • Development of personalised support tools 
  • Demonstration of improved outcomes through clinical evaluation

The aim of such technology will be to provide value added solutions to patients, healthcare professionals and caregivers and payers. 


Who is it for?
This course is suitable for anyone working in regulatory affairs, or individuals involved in this area, who are interested in the implications of combining medical technology and medicines. This will be a valuable course to ensure you are up to date with the current legislation and guidelines.

 

What will I learn?
Click here to view a copy of the programme including each sessions learning objectives.

CPD: 6 

How do I apply? 
Online registration has now closed. If you have any queries or concerns, please email meetings@topra.org or call 020 7510 2560.

Course fees:
Type Member  Non-member 
Standard    £550+VAT £675+VAT 

Discounted places
A limited number of discounted places are available at the rates below. Please email us for a discount code before making your booking.
Those working for regulatory agencies, government agencies or academic institutions 
  £412.50+VAT
  £506.25+VAT
Those working for charities, patient groups or are in full-time education
  £275.00+VAT
  £337.50+VAT

 

Terms and conditions 
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.


When
07/09/2017
Where
CRED Drug-Device Combination Products Radisson Blu Hotel, Malmö, Sweden SE211-25 MALMO SWEDEN
Online registration not available.
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Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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