The Regulatory Landscape for Medical Device Innovations

The Regulatory Landscape for Medical Device Innovations
The TOPRA Roundtable programme has been designed to enable regulatory affairs professionals to discuss their challenges and learn from each other’s experiences in industry and agencies. They offer the chance to be part of a unique learning experience which will enable you to contribute to lively debates and develop action plans that you can implement in your organisation with confidence.


When
: 18 June 2024
Where: TOPRA OFFICE, 3 Harbour Exchange, London, E14 9GE, United Kingdom 
Time: 12:00 - 17:00

Also available as an online option, please click here for the virtual registration option

Navigating the regulatory landscape for medical device innovations and new products

Who Should Attend?



This session is relevant to anyone who is either navigating the medical device regulatory landscape for themselves or their organisation or guiding others. It will also be useful to those who want to prepare their organisation to establish regulatory approval within their product development programmes. The discussions will be relevant to medical devices as well as the expanding market of IVD, combination products and software as a medical device applications.

Individuals from organisations in any area of sector, whether they are general or more specialist, will be able to contribute to and benefit from the debate.

 

Why you should attend

Improve the possibility of funding success by understanding development miles stones and how they relate to regulatory approval including;

  • The benefit of understanding the regulatory landscape, and its key players, at the start of the process
  • Understand the significance of developing a regulatory strategy for your planned device and your development programme
  • What should I invest in to get the best bang for my buck?

Areas of Discussion

The discussion will be as free flowing as possible around the following key discussion points:

  1. Challenges faced by innovators: steep learning curve and confronted with a range of topics such as IP, market dynamics, commercial strategy etc. regulation typically low on the agenda so how to use awareness of regulatory pathways to accelerate R&D and improve chance of market access. Improving access to funding through a knowledge of pathway, costs and indicative conformity assessment timelines.
  2. Finding the Right Guidance: How can I be sure I have the current information, advice and guidance for my idea or product? How can I be certain that I am using the most effective approval process?
  3. Getting the basics right: Intended purpose and functional characteristics drive qualification as a medical device/IVD and indicate risk classification and conformity assessment pathway.
  4. Planning for safety: Using essential principles to identify safety variables, identify standards, plan for testing and determine who to undertake testing and scheduling. Also, touch on cost of failing to consider safety adequately (patient harm, ~10% drop in share price for companies with Class 1 recall in US etc.).
  5. Impact of Product Development Pipeline: How do I plan for this in my development pipeline? How do I make sure I get the right approval outcome so that I can move to production as planned?
  6. Impact on Creativity and Innovation: How can I use the application process in a way which enables and embraces our creativity and innovation?

CPD: This course provides 3 CPD hours upon successful completion

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


Speakers

   

Michael Kipping MTOPRA, Director, Medical Technologies EMEAA for Element Materials Testing, TOPRA President

Michael is Director, Medical Technologies EMEAA for Element Materials Testing, which is a global testing, inspection, calibration and certification business. Previously, he worked for Innovate UK as a Health Innovation Lead managing a UK government grant funding programme (Biomedical Catalyst) that provided £30M per annum to support UK SMEs developing innovative health and life science products.



   

Sue Spencer, Head of In Vitro Diagnostics & Principal Consultant, Qserve Group

Sue leads Qserve’s IVD service, is EU Regulatory and Quality Expert including CDx and Lead Auditor. She has over 30 years’ of experience in the Medical Device and IVD industries including extensive notified body experience.

Sue is an experienced trainer on a variety of IVD topics and particularly enjoys creating workshops to improve hands on experience with the requirements.


   

Pricing  

Standard

  • Member: £285+VAT*
  • Non-member: £365+VAT*
 
When
18/06/2024 12:00 - 17:00
Where
3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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