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 new Medical Device Regulations on MAAs from May 2020?  - This course will explain the current stage of developments as MAHs prepare for the new requirements.



When
:  31 May 2022
Time:  08.45 - 17.15  BST (GMT+1)
Location: Online

Also available as a face to face course, please click here for the face to face registration option

Course overview

As discussed in the joint Human Medicines/ Medical Device session at the TOPRA 2018 Symposium, there are big changes ahead 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
  • Prepare for significant changes in MAA submissions from May 2020
  • 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

Click here to download a copy of the course programme - TBC

Presenters

To be announced 

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    £550+VAT  £675+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 
 £412.50+VAT
 £506.25+VAT
Those working for charities, patient groups or are in full-time education
 £275+VAT  £337.50+VAT

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

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
31/05/2022 08:45 - 17:15
Where
ONLINE
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