Effectively Coping with the European IVD Regulation

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Tuesday, 15 February 2021 - Wednesday, 16 February 2021 (9:00 AM - 12:00 PM) Central European Time

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 17 and 18 February.

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 17 January 2022: Member € 945 | Nonmember € 1,120

After 17 January 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.

 

Location

Hilton Rotterdam

Weena 10, 3012 CM Rotterdam

The Netherlands

Accomodations

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 discounted group rate 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.