CRED Drug-device Combination Products: Major Changes Ahead!

CRED Drug-device Combination Products: Major Changes Ahead!
Are you developing new pharmaceutical products which include (or are they provided with) any type of administration device? If yes, are you fully aware of the impact the new EU Medical Device Regulation on MAAs will have? This course will explain the current state of developments as MAHs prepare for the new requirements.

When:  28 April 2020 
Where:  ONLINE

TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers.

All delegates already booked on the course will be individually contacted. If you require further information please e-mail meetings@topra.org


Course overview

There are big changes ahead in Europe for companies with products incorporating a delivery device - e.g, 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 

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

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
  • 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 a copy of the programme here.

Presenters

 Time Chesworth Tim Chesworth
Senior Director, Regulatory Affairs
AstraZeneca 
 Mark Chipperfield Mark Chipperfield
Principal Consultant and Company Director
Corvus Device Ltd
 Susan Fornero Susanne Fornero-Quaak
Medicinal Expert
BSI
 Theresa Jeary  Theresa Jeary
Company Director
Regulatory & Scientific Affairs Ltd 

Pricing  


Simply log in or create an account and register below.
 
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%

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  - Register your interest

Next steps

Module 18: Drug-device Combinations and Other Technologies - Register your interest

When
28/04/2020
Where
ONLINE
Your VAT country
Your VAT number
NOTE
If your company 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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