EVENT PROMOTED BY
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
VALIDATION AND ACCREDITATION OF IVD AND LABORATORY DEVELOPED TEST (LDT) IN THE NEW “REGULATION EU 2017/746” ERA
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
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
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
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
David Ballantyne – Wilmslow, UK
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
Fulvio Ferrara – Milan, Italy
Nora Gibitz-Eisath – St. Gallen, Switzerland
Bianca Maria Goffredo – Rome, Italy
Dorothee Lebert – Grenoble, France
Pierre Lescuyer – Geneva, Switzerland
Mikaël Levi – Illkirch, France
Daniel Müller – Basel, Switzerland
Federico Ponzetto – Torino, Italy
Michel Rossier – Sion, Switzerland
Christoph Seger – St. Gallen, Switzerland
David Tonoli – Geneva, Switzerland
Michael Vogeser – Munich, Germany
Robert Wardle – Wilmslow, UK
David Ballantyne – Wilmslow, UK
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
Fulvio Ferrara – Milan, Italy
Nora Gibitz-Eisath – St. Gallen, Switzerland
Bianca Maria Goffredo – Rome, Italy
Dorothee Lebert – Grenoble, France
Pierre Lescuyer – Geneva, Switzerland
Mikaël Levi – Illkirch, France
Daniel Müller – Basel, Switzerland
Federico Ponzetto – Torino, Italy
Michel Rossier – Sion, Switzerland
Christoph Seger – St. Gallen, Switzerland
David Tonoli – Geneva, Switzerland
Michael Vogeser – Munich, Germany
Robert Wardle – Wilmslow, UK
Registrations
A limited number of places is available. Registrations is mandatory to attend the event.
Registration fees are as follows:
Early registration (until 31st March) – € 180 (VAT Included)
Regular registration (after 31st March) – € 220 (VAT Included)
Online registrations close on 5th May 2023.
Hotel Booking
For your hotel reservation, you can click on the following button
For any inquiry regarding the hotel booking, please contact:
KENES GROUP
E-mail: [email protected]
Attn: Ms. Anna Ivanova
Congress Venue
LA NUVOLA
ROMA CONVENTION GROUP
Viale Asia, angolo viale Cristoforo Colombo
00144 Roma, Italy
ROMA CONVENTION GROUP
Viale Asia, angolo viale Cristoforo Colombo
00144 Roma, Italy
Scientific Programme
May 20
IVDR and analytical performance
12:00-12:45 Welcome & 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 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 Presentation sponsored by SHIMADZU
Analytical and clinical performance evaluation in IVDR era, a LC/MS kit manufacturer point of view. Mikaël Levi
17:30-18:00 Presentation sponsored by PROMISE
Monitoring of mAbs using LC-MS: from lab-developed methods to CE-IVD kits. Dorothee Lebert
18:00 Closing day
May 21
Analytical performance & clinical performance
Chairs: Bianca Maria Goffredo, Pierre Lescuvier
Session: “IVD: Performance verification”
08:30-9:10 IVD performance verification and comparison among different methods. Nora Gibitz-Eisath
09:10-09:50 Post validation: allerts and tips. Fabrizio Dal Piaz
“Clinical Performance evaluation”
09:50-10:30 Diagnostic sensitivity/specificity/PPV/NPV/likelihood ratio. Michel Rossier
10:30-11:00 Presentation sponsored by WATERS
MassTrak LC-MS/MS solutions – Solving problems in an IVD-R laboratory. David Ballantyne, Robert Wardle
11:00-11:20 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 Presentation sponsored by TECAN
Integrating Dexamethasone in routine LC-MS analysis using IVD Steroid Panel LC-MS Kit – Minimizing regulatory burden by choosing commercially available solution. Federico Ponzetto
13:10-13:40 Presentation sponsored by ROCHE DIAGNOSTICS
Importance of LC-MS/MS in a highly robotized central laboratory: our opinion and experience at Centro Diagnostico Italiano (CDI). Fulvio Ferrara
13:40-13:45 Closing day
Auspices
Sponsor
Please contact the Organizing Secretariat to discover all sponsorship opportunities
Gold Sponsor
Silver Sponsor
Organizing Secretariat
Via Carlo Farini, 81
20159 Milan, Italy
[email protected]
Ph. + 39 02 66802323 ext. 924