二月 01, 2023 - 二月 01, 2023
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
Early bird price: £ 250,00 | € 286,00 valid until 31st of December
Normal price: £ 350,00 | € 399,00
Meet our IVD team in-person to discuss Going global with your IVDs
How to leverage your IVDs across global regulatory systems
Qserve Group is pleased to organize a 1-day in-person event in the UK on Wednesday the 1st of February where our IVD and local representation experts present the developments regarding the IVDR and insights on the best strategy for going global with your IVDs. We invite you to meet our complete team of global IVD specialists for a day of discussion and to have a chance to answer all your questions.
At Qserve we know that IVD manufacturers are busy preparing for the IVDR but due to the extended approval times are also looking at how to enter other markets globally. The aim of this event is to learn from the cumulative experience of our IVD team to learn about the latest changes and expectations under the IVDR but also look at how data can be repurposed for other markets and how to gain in-country representation for the US and rest of world countries to either maximise the opportunity from the IVDR or to bridge the gap whilst waiting for notified body approval.
This in-person training event will give participants the opportunity to have an update on regulatory news regarding IVDs and the latest news topics to better understand them. Learn how to go global with your IVDs leveraging across global regulatory systems from the industry's leading IVD experts. Qserve will also deal with the concerns of in vitro diagnostic manufacturers in the daily exercise of their activity.
Join Sue Spencer, our head of IVD, who brings together our global IVD team with decades of practical experience in disciplines from design, to clinical performance studies including preparing IVDR technical files and 510ks and PMA submissions for this in-person meet and greet the day. Our expert Danielle Motta, head of Global Registrations will guide you in going global with your IVDs in countries beyond the US and Europe. She will also give the latest news topics about the UK regulatory landscape and the latest trends in global market access.
Preview of the program:
- IVDR Update
- IVDR Lessons learned so far
- Approaches to entering the US market working with FDA
- Update on the UK Regulation and expected implementation
- ROW market access
- Panel discussion/round table
- Followed by informal networking
The sessions are supported by real-life case studies and practical examples that will provide insight into IVD strategies. This day will allow participants to take part in interactive sessions supported by Q&A sessions and roundtable discussions led by experienced professionals. Through this knowledge-sharing platform, participants will receive practical advice needed to leverage IVDs across global regulatory systems.
If you need recommendations about hotels and or travel to Farnborough, Hampshire UK, please contact email@example.com. Farnborough is 30min from London Waterloo, close to the M3 motorway, and easily accessible from Heathrow and Gatwick airports.