Event

IVD Training Day UK | Going global with your IVD's. How to leverage your IVDs across global regulatory systems

February 01, 2023 - February 01, 2023 / Europe

Event: In-person

Date: Wednesday the 1st of February 2023

Time: 9:00-17:00 GMT 

Location: Aviator Hotel | 55 Farnborough Road | Farnborough | Hampshire | GU14 6EL | United Kingdom

Language: English

January price: £ 250,00 | € 286,00 valid until 31st of January 

Qserve IVD Event | How to leverage your IVDs across global regulatory systems

There is still time to register for Qserve’s IVD event in Farnborough on the 1st of February. We are pleased to announce that in addition to Qserve’s global IVD team, we will be joined by three Notified Bodies/ prospective UK Approved Bodies.

IVD manufacturers are grappling with the changing regulations in Europe, and many are changing their market access strategy and considering market entry to the US or ROW before the EU. This creates challenges in designing devices for multiple markets and preparing appropriate regulatory submissions.

During the workshop, we will consider each phase in developing an IVD, the regulatory expectations for Europe, the US, and the UK, and the ROW market entry. We will also be joined by Danielle Motta Qserve, Head of Global Reg, who will join us for the meeting to answer questions about EU Rep, US agent, UK Rep, plus ROW in-country representation. 

The day will be interactive with plenty of time for Q+A, including participation from Notified Body BSI, DEKRA, and TÜV SÜD.

Why should you attend?

Whether you are developing a new product, preparing on-market / legacy devices for the IVDR, or considering future market entry strategies, this meeting will provide great insight into the expectations of European and US regulators.
Good technical documentation can support submissions worldwide, but there are tips and tricks on presenting the data to meet the expectation of regulators.
Qserve is experienced in supporting IVD companies entering the EU and US markets. This is an excellent opportunity to identify pitfalls and possible solutions when creating technical documentation for global market entry, understand expectations based on practical experience, and prevent unnecessary duplication of work.
This is a great chance to meet the Qserve team and pick their brains.
If you are considering ROW markets, this is an excellent opportunity to understand in-country representation in the EU, US, and UK Rep many countries ROW.
It is value for money to pack all this in one day!
Join our full day with sessions and have your questions answered at the in-person IVD event

The Agenda

Time

Topic

Morning

Feasibility/Planning

  • Design and development planning
  • Creating a regulatory plan

Design (verification)

  • Analytical studies
  • Risk Management
  • Literature searches (for EU)
  • Refocusing Regulatory for EU IVDR (PEP, State of the Art SoTA, etc.)

Lunch

 Lunch is provided, and a networking opportunity

Afternoon

Design (validation)

  • Clinical performance study
  • Method comparison in US & how this may support SoTA in the EU
  • Writing clinical evidence to support IVDR
  • EU in-house exemption
  • EU study registrations

QMS

  • QMS to support global market entry

Commercializing

  • Post Market Surveillance
  • IVDR-specific PMPF, PSUR
  • In-country representation

Farnborough is 30min from London Waterloo, close to the M3 motorway, and easily accessible from Heathrow and Gatwick airports. 

If you need recommendations about hotels and or travel to Farnborough, Hampshire UK, please contact marketing@qservegroup.com

Sue Spencer
Christie Hughes, MPH, MT (ASCP), RCC-IVDR
Kristiane Schmidt, PhD
Joshua Spencer
Weiwei Wang, PhD/MSc
Diane M. Ward, PhD
Lorry Weaver, MT(ASCP), CLS(NCA)
Post date: October 06, 2022
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