CRED Regulation of Drug Device Combination Products

CRED Regulation of Drug Device Combination Products
Are you developing new pharmaceutical products? Do they include (or are they provided with) any type of administration device?  If yes, are you fully aware of the impact of the Medical Device Regulations on MAAs which came into effect in May 2021? This course will explain the current stage of developments as MAHs prepare for the new requirements.

When:  6 March 2024
Time:  08.45 - 17.30  GMT  (CET+1)
Location: TOPRA, 6th Floor, 3 Harbour Exchange, London, E14 9GE, United Kingdom 



Course overview

The MDR brought big changes in Europe for companies with products incorporating a delivery device - eg, pre-filled syringes, auto-injectors and inhalers. The US and other regions are also focusing more on how to regulate these increasingly technical products appropriately. As such, this course will cover: 

  • An introduction to combination products
  • The evolving regulatory landscape 
  • The impact of the new EU Medical Device Regulation
  • New guidance documents 
  • Considerations for development of "combined products",  including design controls and human factors 
  • The challenges, similarities and differences between the EU, US and emerging markets 
  • Industry case study 

Benefits to delegates

  • Understand the current legislation and guidelines
  • Learn about solutions to the practical, technical and regulatory issues
  • Implement the changes in MAA submissions which the MDR brought about
  • Talk to the experts and share experiences with your peers 
  • Become equipped to deal with different global markets 
CPD: This course provides 8 CPD hours upon successful completion. 

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

Download the current programme HERE

Presenters

The course will be chaired by Janine Jamieson - IPQ and Ludivine Petit - Life2Science

  • Ola Oyinloye - AstraZeneca
  • Louise Place, GSK
  • Ann Jans, FAMHP
  • Ludivine Petit
  • Amber McNair, IQVIA
  • Jon Sutch, BSI 
  • Chris Le Page, UCB 
  • James Bertram , FDA
Suitable for
  • Anyone working in regulatory affairs.
  • Individuals who are interested in the implications of combining medical technology and medicines.
  • Device component suppliers to the pharmaceutical industry 

Pricing  

Type Member Non-member 
Standard    £570+VAT  £695+VAT

Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.

  
Those working for regulatory agencies, government agencies or academic institutions 
  £427.50+VAT
  £521.25+VAT
Those working for charities, patient groups or are in full-time education
  £285+VAT  £347.50+VAT

*VAT, if applicable, is charged at VAT rate of 20%

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions

Related courses

Module 20: Regulation of Electrical, Electronic and Software Devices 

Next steps

Module 18: Drug-device Combinations and Other Technologies - Register your interest
When
06/03/2024 07:45 - 16:15
Where
London UNITED KINGDOM
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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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