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Drug-device Combination Products: Major Changes Ahead!

Drug-device Combination Products: Major Changes Ahead!
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
:  9 May 2019
Where:  TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time:  09.00 - 17.00

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.

Presenters



Janine Jamieson
IPQ Publications

Margareth Jorvid 
Methra Uppsala

Tim Chesworth
AstraZeneca
 
Josie Wright
AstraZeneca

April Kent

Amgen

Mark Chipperfield 
Corvus Device

Abigail Moran
MHRA
 

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
09/05/2019
Where
TOPRA 6th Floor, 3 Harbour Exchange London E14 9GE UNITED KINGDOM
Online registration not available.
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Register now

 

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