Effectively Coping with the European IVD Regulation

12.0
RAC Credits
EuropeEurope In-PersonIn-Person
Tuesday, 18 October 2022 (9:00 AM) - Wednesday, 19 October 2022 (5:00 PM) Central European Time (CET)
Weena 10
Rotterdam, Zuid-Holland, Netherlands, 3012 CM

Among the key areas open to interpretation and which need further guidance in the IVD-R text are:

  • Applicability of clinical evidence requirements to Class A devices
  • Precise understanding of the PMPF process and how it can and shall be used
  • Clear description of design control best practices and potential impact on laboratory developed tests (LDTs)
  • A practical way to the definition and documentation of state of the art

Maurizio Suppo, Owner & VP, Qarad will explore these topics in detail with clear "how to do" examples during a two-day, in-person workshop at the Hilton Rotterdam in The Netherlands on 18 and 19 October.

Delegates will acquire an in-depth understanding of how to create and organize the technical documentation related to IVD devices and common mistakes and pitfalls to avoid to ensure a right-first-time submission to their notified bodies.

The practical implications of clinical evidence and performance evaluation of IVD devices across all the spectrum of the four regulatory classes (A, B, C and D) will be covered. And specific attention will be given to the applicability of clinical evidence requirements to Class A devices and to the importance of a flawless design control process for the Annex IX conformity assessment procedure.

Pricing Amounts and Deadlines

Before 18 September 2022: Member € 945 | Nonmember € 1,120

After 18 September 2022: Member € 1,080 | Nonmember € 1,264

Speaker(s)

Maurizio Suppo, Owner & VP, Qarad

With a PhD in molecular biology from the University of Turin (Italy) in 1985, Maurizio has more than 34 years of experience in the field of regulatory affairs and quality systems in the in-vitro diagnostic (IVD) industry. He held executive positions at Sorin Biomedica (now DiaSorin), Becton Dickinson, Dade Behring and Siemens Healthcare. He has been director of the European Diagnostic Manufacturers Association (EDMA) and, in that role, represented the IVD industry position in the drafting of the European IVD Directive 98/79/EC.

His knowledge and experience in RA&QS go beyond the European borders. A trained ISO-9001 & 13485:2016 auditor, Dr. Suppo is also an expert MDSAP auditor with more than 500 MDSAP audit hours as a lead auditor.

Maurizio Suppo joined Qarad in July 2012 and became partner and co-owner in January 2016. He is a regular speaker and chairman at international conferences and published more than 20 articles in the specialized press. He is fluent in Italian, English, French with a good knowledge of Spanish.


Pieter Bogaert, Device Compliance Expert, Qarad

Pieter Bogaert is an IVD specialist with a wealth of experience in flow cytometry. Pieter graduated with a Ph.D. in Biotechnology at Ghent University, after which he stayed on to work there. He later expanded his knowledge by working as a Flow Cytometry specialist at BD Biosciences and Cerba Healthcare. Pieter has written multiple articles, published in various international, peer-reviewed journals. At Qarad, Pieter’s responsibility is to ensure compliance of IVD product technical documentation with the European Regulation. This includes gap assessment and other consulting services, as well as technical file writing and compilation. Given his previous professional experience, Pieter’s in-depth areas of expertise are medical laboratory devices, clinical flow cytometry reagents and instruments.


Agenda

Day 1 – 18 October 2022

 

8:30 (CET)

Registration and Welcome Coffee

9:00

General introduction to the IVD-R

9:15

-        major differences between IVD-R and the old IVD-Directive

-        clear understanding of the transition period

-        Notified Bodies – who are they, how they work, how to work with them, who controls them

-        clear definition of IVD, main device & components vs accessories

10:30

Break

11:00

-        IVD Legacy Devices  - instruments & reagents

-        General Safety and Performance Requirements

-        Classification of devices

-        Conformity Assessment Procedures

-        What is Technical Documentation ? TD format.

12:30

Lunch

13:30

-        Performance Evaluation of IVD Devices

-        Identification & Definition of State Of The Art

-        Clinical Evidence

-        Performance Evaluation Plan

-        Scientific Validity

15:00

Break

15:30

-        Analytical Performance

-        Clinical Performance

-        Clinical Performance Studies, Plan & Report

-        Performance Evaluation Report

-        Design Control best practices

17:00

Close for the Day

 

Day 2 – 19 October 2022

 

9:00 (CET)

Continuation day 1

-        Placing IVD on the market vs making available vs putting into service. Understanding the regulatory terminology & how it relates to the commercial activities.

-        IVD-R impact on legacy devices

-        Post market surveillance

10:30

Break

11:00

-        Vigilance

-        Market Surveillance

-        Understand relationship between PMS and PMPF

-        Proactive use of PMPF Studies

12:30

Lunch

13:30

-        Understanding the definition, role & obligations of Economic Operators. Why they are essential in the PMS process. How to deal with them.

-        Supplier Management as per IVD-R. Standard vs custom suppliers / contract manufacturers.

15:00

Break

15:30

-        Quality/Regulatory Agreements. Key points to address

-        How to ensure compliance and a smooth cooperation between the various actors in the supply chain.

17:00

Close for the Day


Location

Hilton Rotterdam

Weena 10, 3012 CM Rotterdam

The Netherlands

Accommodations

RAPS has secured a discounted room block at the Hilton Rotterdam for workshop attendees. Please mention that you are participating in the RAPS workshops.

Check-in time is 15h00. Although the hotel will make every reasonable effort to accommodate guests who arrive before the check-in time, the client recognizes that guest rooms may not be immediately available. Baggage storage will be available. The hotel check-out time is 12.00 on the day of departure.

Room Rate: € 165.00 per night

Room includes:

  • Complimentary breakfast
  • Free WIFI Internet for all in-house guests
  • Tax (VAT)

Book your room here >>

Access & Public Transport

The Hilton Rotterdam is located in the city centre, just 500 metres away from Rotterdam Central Station.

Airport

There is a direct train connection from Schiphol airport to Rotterdam central Station which takes about 26 minutes.

For real-time information, please visit the mobile website OV9292.

Taxi

Taxis are available directly from the airport outside the departure and arrival halls. You can choose a regular taxi, a luxury Schiphol Business Taxi or a Schiphol Travel Taxi minibus.

If you prefer to pre-order a taxi in advance, don’t hesitate to contact Schiphol Transfer Assistance (STA). Just call +31 20 601 3400 or visit the STA desk in Schiphol Plaza. You can find them in Arrivals 4, open anytime day or night.

Parking

The hotel has parking at a cost of € 30 per night.


Event Policies

Vaccination Requirement

RAPS will require proof of COVID-19 vaccination for all participants attending RAPS in-person workshops & programs. Your well-being is RAPS’ #1 priority.

Unvaccinated individuals or those unable to provide proof of vaccination in advance will not be permitted to attend.

RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.

Cancellations and Refunds

All cancellation requests must be submitted in writing to support@raps.org. Cancellation requests received by Friday, 27 May 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 27 May 2022 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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