20-21 May 2023

CLINICAL MASS SPECTROMETRY:
VALIDATION AND ACCREDITATION OF IVD AND LABORATORY DEVELOPED TEST (LDT) IN THE NEW “REGULATION EU 2017/746” ERA

EVENT PROMOTED BY

Over the last 10 years, mass spectrometry (MS) has become extremely popular in clinical chemistry laboratories. At the same time, there has been an evolution in regulations, standards and protocols for both validation and verification of analyses on this instrumentation (EMA, ISO, CLSI, etc.), up to the most recent European Regulation 2017/746 (IVDR). To efficiently integrate mass spectrometry in laboratory, a clinical chemist must therefore face new challenge related to the impact of the new European Regulation 2017/746 concerning the verification and validation of analyses. During the meeting, you will therefore acquire the skills to prepare
• Experimental designs to verify/validate an analysis in MS
• Dossiers for the national competent authority for Laboratory Developed Test (LDT) assay, in accordance with the requirements of the new European Directive IVDR 2017/746
• Dossiers for the accreditation of mass spectrometry In Vitro Diagnostic (IVD) Kit.
The meeting aims at providing participants with a complete overview of procedures and experimental designs to prepare the documentation for the analysis accreditation process (IVD & LDT) and/or for the national competent authorities inspection (LDT).

Dr Marco Cantù

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Faculty & Committees

Scientific Committee

Sergio Bernardini – Rome, Italy
Pierre-Alain Binz – Lausanne, Switzerland
Marco Cantù – Bellinzona, Switzerland – SC Chair
Dario Cattaneo – Milan, Italy
Alessio Cremonesi – Zurich, Switzerland
Bianca Maria Goffredo – Rome, Italy
Pierre Lescuyer – Geneva, Switzerland
Katharina Rentsch – Basel, Switzerland
Tommaso Trenti – Modena, Italy

Organising Committee

Marco Cantù – Bellinzona, Switzerland
Fabrizio Dal Piaz – Salerno, Italy
Bianca Maria Goffredo – Rome, Italy – OC Chair
Viviana Izzo – Salerno, Italy
Massimo Tempestilli – Rome, Italy

Faculty

Sara Baldelli – Brescia, Italy
Pierre-Alain Binz – Lausanne, Switzerland
Giuliana Cangemi – Genoa, Italy
Marco Cantù – Bellinzona, Switzerland
Dario Cattaneo – Milan, Italy
Alessio Cremonesi – Zurich, Switzerland
Fabrizio Dal Piaz – Salerno, Italy
Ugo De Grazia – Milan, Italy
Amedeo De Nicolò – Turin, Italy
Nora Gibitz-Eisath – St. Gallen, Switzerland
Bianca Maria Goffredo – Rome, Italy
Pierre Lescuyer – Geneva, Switzerland
Daniel Müller – Basel, Switzerland
Michel Rossier – Sion, Switzerland
Christoph Seger – St. Gallen, Switzerland
David Tonoli – Geneva, Switzerland
Michael Vogeser – Munich, Germany

Registrations

A limited number of places is available.
Registrations is mandatory to attend the event.
Registrations will open soon. Stay tuned!

Hotel Booking

For your hotel reservation, you can click on the following button
BOOK YOUR ACCOMMODATION

For any inquiry regarding the hotel booking, please contact:
KENES GROUP
E-mail: aivanova@kenes.com
Attn: Ms. Anna Ivanova

Congress Venue

LA NUVOLA
ROMA CONVENTION GROUP
Viale della Pittura, 50
00144 Roma, Italy

Scientific Programme

May 20

IVDR and analytical performance

12:00-12:45 Welcome Cocktail & Registrations
12:45-13:00 Greetings and introduction

Chairs: Pierre-Alain Binz, Marco Cantù

Session:“Current regulations”

13:00-14:00 Plenary Lecture: the new Regulation EU 2017/746
LDT: Validation of endogenous/exogenous molecules
Michael Vogeser

Session: “LDT: Validation of endogenous/exogenous molecules”

14:00-14:40 Is it really that? Analytical Specificity/Interference/matrix effect/cross reaction/carry. Amedeo De Nicolò
14:40-15:20 How much is it? Analytical sensitivity/LOQ/measurement interval/Linearity. David Tonoli
15:20-15:40 Coffee Break
Chairs: Giuliana Cangemi, Christoph Seger
15:40-16:20 How far we are? Trueness/Precision/Accuracy/Recovery. Pierre-Alain Binz
16:20-17:00 What, how, when…Preanalytic, sample manipulation, stability of reagent and sample. Sara Baldelli
17:00-17:30 SPONSORED PRESENTATION
17:30-18:00 SPONSORED PRESENTATION
18:00 Closing day

May 21

Analytical performance & clinical performance

Chairs: Bianca Maria Goffredo, Pierre Lescuvier
08:30-9:00 SPONSORED PRESENTATION

Session: “IVD: Performance verification”

09:00-9:40 IVD performance verification and comparison among different methods. Nora Gibitz-Eisath
09:40-10:20 Post validation: allerts and tips. Fabrizio Dal Piaz

“Clinical Performance evaluation”

10:20-11:00 Diagnostic sensitivity/specificity/PPV/NPV/likelihood ratio. Michel Rossier
11:00-11:20 Coffee Break
Chairs: Alessio Cremonesi, Ugo De Grazia
11:20-12:00 “Biological variance & Reference range” expected value. Dario Cattaneo
12:00-12:40 Case study: validation Protocol examples. Daniel Müller
12:40-13:10 SPONSORED PRESENTATION
13:10-13:40 SPONSORED PRESENTATION
13:40-13:45 Closing day
13:45-14:45 Light lunch

Auspices

Sponsor

Please contact the Organizing Secretariat to discover all sponsorship opportunities

Silver Sponsor

Organizing Secretariat

 

Via Carlo Farini, 81
20159 Milan, Italy

 

nicholas.vergani@mzevents.it
Ph. + 39 02 66802323 ext. 924