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Insights from EA: Latest Developments and Achievements


CEN, CENELEC, EA, EURAMET, and WELMEC join forces to reinforce and promote the European Quality Infrastructure
On 7 March, the five Regional Quality Infrastructure Organizations of Europe, the European Committee for Standardization (CEN), the European Committee for electrotechnical standardization (CENELEC), the European co-operation for Accreditation (EA), the Association of the National Metrology Institutes in Europe (EURAMET), and the European Cooperation in Legal Metrology (WELMEC) signed a Memorandum of Understanding to create the European Ql Network.
The Network Partners are organizations who represent, with a unique voice, their areas of activity.
Through the agreement, the Network Partners pledge to collaborate to strengthen the Quality Infrastructure in Europe, including:

  • Raising awareness of QI and its benefits towards industry stakeholders and the European Commission;
  • Increasing the understanding and visibility of each other’s services and activities;
  • Sharing information on matters of common interest and opportunities; and
  • Representing the European Quality Infrastructure at the international level.


Adoption of the EU Cybersecurity Certification Scheme on Common Criteria
The European Commission adopted on 31 January 2024 the implementing regulation concerning the EU Cybersecurity Certification Scheme on Common Criteria (EUCC). It is the first approved scheme under Regulation (EU) 2019/881 (Cybersecurity Act).

This regulation specifies the roles, rules, obligations, and structure of the European Common Criteria-based cybersecurity certification scheme in accordance with the European cybersecurity certification framework outlined in the Cybersecurity Act.
The implementing regulation refers to documents known as State-of-the-Art (SoA). There will be – inter alia – three SoA documents regarding:

  • Accreditation of ITSEFs (Information Technology Security Evaluation Facility),
  • Accreditation of Certification Bodies (CBs), and
  • Authorisation of CBs and ITSEFs.


Webinar on European Blockchain technology for the use in accreditation and certification
327 participants attended the webinar organized by EA, under the auspices of the European Commission, a webinar on European Blockchain technology for the use in accreditation and certification, on the 29th of February 2024.

Jose Manuel Panizo Plaza (European Commission, DG DIGIT) and Lia Potec (European Commission, DG MOVE) explored the role of the European Blockchain Services Infrastructure (EBSI) in the context of the European accreditation and certification ecosystem. The discussion centered on the prospective role of EBSI in facilitating the real-time dissemination of the accreditation status pertaining to Conformity Assessment Bodies (CABs). Furthermore, it addressed the verification of the certification status associated with a myriad of products and services certified within the European Union by said CABs

Annual Report 2023
The EA Annual Report 2023 has just been released.

You can read the interactive report here:

You can download the full report here

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EIAC update


EIAC’s peer evaluation for existing and new scope
The peer evaluation of Emirates International Accreditation Centre (EIAC) was conducted on 20-24 November 2023. The peer evaluation was jointly conducted by the Asia Pacific Accreditation Cooperation (APAC) and Arab Accreditation Cooperation (ARAC). The eight-member peer evaluation team was comprised of peer evaluators from accreditation bodies of Thailand, Japan, Indonesia, India, Sri Lanka, Egypt, Tunisia, and USA.

The peer evaluation covered the existing scope ISO/IEC 17021-1 (for ISO 9001, ISO 14001, ISO 45001, ISO 22000 & ISO 27001), ISO/IEC 17065 and ISO/IEC 17024 and new scope of ISO/IEC 17043 Conformity Assessment-General requirements for the competence of proficiency testing providers.

EIAC participated in Arab Health Exhibition & Congress 2024
The Emirates International Accreditation Centre (EIAC) participated in Arab Health Exhibition and Congress held on 29 January to 1st February 2024. Arab Health is largest exhibition and forum of medical field in the region. A large number of exhibitors of medical products including devices, pharmaceuticals, healthcare service providers and medical professionals attended the exhibition and discussion forums. The EIAC had a dedicated booth in the exhibitions. Large number of medical professionals from healthcare sector including medical laboratories visited the EIAC booth.

EIAC’s new scheme for persons certification bodies
The Emirates International Accreditation Centre (EIAC) has launched a new scheme for ISO/IEC 17024 persons’ certification bodies. The certification scheme is developed by the regulatory body, Health & Safety Department of Dubai Municipality. The aim of the scheme is to enhance the health and safety conditions at laborers’ accommodations. As per the scheme requirements, the accredited persons’ certification bodies will be responsible to provide certifications to competent “health & Safety Officers” for laborers’ accommodations. The laborers and other people living in those accommodations will be the beneficiary of the scheme.

EIAC attended ARAC’s annual meetings in Riyadh, Saudi Arabia
The 11th annual meetings and general assembly of Arab Accreditation Cooperation (ARAC) were held from 5th to 14th December 2023 in Riyadh, Saudi Arabia. The meetings were hosted by the Saudi Accreditation Center (SAAC). EIAC delegation, headed by Ms. Amina Ahmed Ahmad, CEO attended the annual meetings.

EIAC conducted trainings for conformity assessment bodies
The Emirates International Accreditation Centre (EIAC) has conducted various training sessions over the past few months.

ISO 15189 training was conducted for medical laboratories and assessors and experts. Dr. Venkatesh Thuppil was the resource person. The training was conducted on 26-29 February 2024.

ISO/IEC 17024 training was conducted for persons certification bodies. The training also covered the conformity assessment requirements. The training was attended by delegates from various public and private entities including Dubai Police. Engr. Muhammad Shahid Rasool was the resource person for the training. The training was conducted on 21-22 February 2024.
Trainings of transition to new version of ISO 15189, Biobank and Halal standards were also conducted. Dr. Venkatesh Thuppil, Mr. Mohammed Abdel Motagaly and Mr. Erik Reisdorf were resource persons.

EIAC jointly hosts APAC annual meetings
The Emirates International Accreditation Centre (EIAC) along with Emirates National Accreditation System (ENAC) and GCC Accreditation Center (GAC) will jointly host the annual meetings of Asia Pacific Accreditation Cooperation (APAC) in Dubai, UAE on 13-18 July 2024. This is the first time that annual meetings and general assembly of APAC being held in the UAE and middle east region.

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MAURITAS holds Training Course on ISO 15189:2022

In the ever-evolving realm of healthcare, adherence to internationally recognized standards is of utmost importance to ensure quality, reliability, and credibility of laboratory services. The ISO 15189 standard, updated in December 2022, serves as a cornerstone for quality management and technical competence in medical laboratories.

The Mauritius Accreditation Service (MAURITAS) has, as of now, accredited 7 medical laboratories in accordance with ISO 15189:2012, “Medical Laboratories – Requirements for quality and competence’’, for a total of 148 parameters in the medical subfields of immunology, biochemistry, haematology and microbiology. Recognizing the importance of staying abreast of the updates to the standard, MAURITAS organised a training course from 05 to 08 February 2024, for its staff, assessors and other stakeholders.

Dr Sambhu Chakraborty and the 21 participants

 

Participants during the training course

Mr Chankar Bheekhun (L), Accreditation Manager of MAURITAS
presenting a souvenir gift to Dr Sambhu Chakraborty (R)

 

The training course was facilitated by Dr. Sambhu Chakraborty from the Institute of Applied Quality Management & IAQM Consultants Pvt Ltd, India. With his expertise, Dr. Chakraborty guided the 21 participants through an intensive curriculum that covered various aspects of the ISO 15189:2022 standard and its practical implications. Participants had the opportunity to network with industry peers, forge valuable connections, and build a community committed to upholding standards of excellence in laboratory practice.

This training course has equipped professionals with the knowledge and skills to navigate the revised standard, and drive continuous improvement within the medical laboratory sector.

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ODAC and CODIA sign a collaboration agreement


Santo Domingo, Dominican Republic
March 21st, 2024

The Dominican Accreditation Body (ODAC) and the Dominican College of Engineers, Architects, and Surveyors (CODIA) signed a collaboration agreement that will enable the management of projects to benefit the construction sector.

The agreement was signed by the director of ODAC, Ángel David Taveras Difo, and the president of CODIA, Juan Villar González, with the aim of contributing to the institutional strengthening of both entities.

Ángel David Taveras Difo valued the signing of the agreement, which will be a great contribution to strengthening the quality infrastructure and confidence, in the acquisition of products and services.

“The signing of this agreement reaffirms our commitment to quality and the generation of trust in the country’s construction sector, whose activities directly impact the growth of commerce, tourism, and consequently, the Dominican economy, and of course, the safety of the Dominicans,” said the official.

The agreement establishes that CODIA will prepare a regulatory resolution that establishes a proposal for the ODAC accreditation process for conformity assessment bodies.

In addition, it contemplates the joint development of training programs that facilitate the training of technical or managerial personnel of both entities, taking care of compliance with the impartiality requirements by international standards and criteria.

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Pathcon 2023 – India

The Annual Conference of the Association of Pathologists, PathCon, and LabExpo 2023, held at The Lalit in New Delhi on 16th & 17th December 2023, emerged as a key nexus for over 300 medical professionals. Comprising physicians, pathologists, microbiologists, and biochemists committed to quality assurance and accreditation processes, PathCon served as a beacon of collaboration within the realm of pathology.

The gathering coordinated a variety of educational activities, with lectures spanning growing trends, diagnostic intricacies, and nuanced treatment paradigms. Case study presentations provided fertile ground for the development of diagnostic skills, while hands-on workshops augmented practical knowledge across histopathological nuances and molecular diagnostics. Poster presentations encouraged spirited discussions, enhancing and expanding upon the collective knowledge of those present.

PathCon fostered interdisciplinary interactions, cultivating a holistic ethos towards patient-centric care. Attendees seized networking opportunities, engaging with peers, mentors, and industry stalwarts to cultivate enduring relationships. Mentorship flourished, nurturing a legacy of excellence.

Professional development was was enhanced by PathCon’s Continuing Medical Education (CME) credits, ensuring ongoing knowledge cultivation and certification fulfilment. Participation elevated professional eminence, paving avenues for career progression and fostering innovation in patient care. PathCon stands as a stronghold of education, offering intellectual, networking, and professional developmental riches. Medical professionals continue to enrich their understanding, spearheading transformative changes in pathology and ultimately enhancing global healthcare excellence.

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JAS-AU Expanding Accreditation Services for the Accreditation of PTP

Jordanian Accreditation System – Accreditation Unit (JAS-AU) is proud to announce that it has expanded its services to include accreditation of Proficiency Testing Providers (PTP) according to the requirements of ISO/IEC 17043 standard.

JAS-AU has been working diligently to expand its services in the field of accreditation of PTP since 2022. This is due to the importance of proficiency testing results and their use as a tool to demonstrate conformity assessment bodies’ (CABs) competence, in order to improve the national quality infrastructure. It also recognises the increasing demand of local PTPs to overcome the obstacles that CABs (laboratories specifically) face when participating with providers abroad. For example, shipping costs have recently increased, and increasing accreditation areas which it is difficult to cover by PTP, and the restrictions by the customs agency in all around countries.


Technical support for this project was provided by UNIDO, and an accreditation expert was involved in the project. Several activities took place according to a predefined plan as follows:

  • Hosting a training course from 2 – 5 January 2023 that covered ISO/IEC 17043:2010 requirements (Technical & Management requirements) and the new revision of ISO/IEC 17043, Assessment techniques, and reporting. The course was attended by JAS-AU assessors and staff including personnel responsible for evaluating the outcome of assessments and of decision-making,
  • Reviewing JAS-AU management system and preparing a gap analysis against the assessment criteria for the accreditation of PTP, and then making the necessary changes to the management system,
  • Training on the new changes and on the preparation for mock assessment on 15 October 2023, and
  • Two onsite assessments performed by JAS-AU assessment teams under observation of the expert from 16 – 19 October 2023. The assessments were performed on two PT providers who expressed their willingness to have a mock assessment within the project activities.

 


The desired goal of the visits, which was to evaluate the competence of JAS-AU and its assessment teams was achieved, as the technical expert expressed his satisfaction and praised the competence of the assessment team members, the extent of their commitment, and their ability to assess the requirements.

Consequently, JAS-AU has officially launched a new service to accredit PTP according to ISO/IEC 17043 and ILAC policies.

JAS-AU will continue to build on this achievement and prepare to apply for extending its signatory status of the Arab Accreditation Cooperation MLA (ARAC MLA) to cover the scope of accreditation of Proficiency Testing Providers. This will ultimately lead to the extension of its ILAC MRA signatory status.

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QAI CIA News

The QAI Centre for international Accreditation (QAI CIA), a fairly young organisation, started its accreditation activities for Conformity Assessment Bodies (CABs) in 2017 with the following accreditation programmes:

2017
• Accreditation of Medical Testing Laboratories as per ISO 15189

2018
• Accreditation of Testing laboratories as per ISO/ IEC 17025

2021
• Biobanking Accreditation as per ISO 20387 (For the First time in India)

2022
• Accreditation of Calibration laboratories as per ISO/ IEC 17025

2023
• Accreditation of Proficiency Testing Providers as per ISO 17043
• Accreditation of Reference Material Producers as per ISO 17034
• Accreditation of Inspection Bodies as per ISO 17020

We are happy to announce that QAI CIA achieved international recognition by joining the APAC MRA for Testing (ISO/IEC 17025) and Medical Testing (ISO 15189) on 31 October 2022 and the ILAC MRA for Testing (ISO/IEC 17025) and Medical Testing (ISO 15189) on 10 December 2022. This makes us the second AB in India to achieve membership of the ILAC MRA. We intend to add more accreditation programmes to the ILAC MRA as we progress.

This recognition has helped us in expanding and promoting our business, and accepting a greater number of applications for accreditation.

We are also pleased to announce that QAI CIA is now present in Asia, Africa and the Middle, East as an accreditation partner. We are motivated to excel in supporting countries that may not have their own Accreditation Body and / or a specific accreditation programme.

We are committed to hold to our Vision and Values by providing a credible accreditation mechanism. We are certainly would like to contribute towards our national government’s agenda of Viksit Bharat (Developed Bharat) in the conformity assessment ecosystem and do our bit to take Bharat (India) to the 1st World Ranking in Quality and Accreditation Infrastructure.

Further, we are open for bilateral collaboration to learn, share and support these shared goals with organisations in different countries.

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AERSSC Nepal Stakeholder Conclave update

The Accreditation Education Research and Scientific Services Center Pvt.Ltd (AERSSC) held a Stakeholder Conclave on 9 March 2024. For an update on the Conclave click on the following link.
AERSSC Article

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ILAC Secretariat News April 2024

The ILAC MRA 

The scope of recognition of the recognised regions to the ILAC MRA is available from   Recognised Regional Cooperation Bodies International Laboratory Accreditation Cooperation (ilac.org)

There are currently 114 ILAC MRA Signatories representing 118 economies​. The ILAC MRA covers recognition for accreditation in the areas of calibration (ISO/IEC 17025), testing (ISO/IEC 17025), medical testing (ISO 15189), inspection (ISO/IEC 17020), proficiency testing providers (ISO/IEC 17043) and reference material producers (ISO 17034). The list of signatories to the ILAC MRA is available from the ILAC MRA Signatory Search.

The ILAC MRA Annual Report 2023 and associated infographic will be published in May 2024 and available on the website shortly thereafter.

Work to extend the ILAC MRA to include the accreditation of biobanks has now been completed, however no applications have been received to date.

World Accreditation Day 2024 – Accreditation: Empowering Tomorrow and Shaping the Future 

09 June 2024 marks World Accreditation Day (WAD), a global initiative established by IAF and ILAC to highlight the value of accreditation. As WAD falls on a Sunday this year, the majority of events will take place on Monday 10 June.

WAD 2024 Resources

The joint statement by the IAF and ILAC Chairs, the brochure and the poster are now available for downloading here along with editable versions of the poster to enable members to add their logos or translate the text. Editable versions of the Brochure are available upon request from the ILAC Secretariat.

WAD 2024 Video

The WAD 2024 video is now available from the IAF/ILAC YouTube channel or using the direct link

Case studies and research on the recognition of the ILAC MRA by governments and regulators are available from the Public Sector Assurance website. The website is a collaborative initiative of the INetQI members and there are over 330 case studies, 90 research papers and 60 supporting materials available to view.

The Business Benefits website is a reference website designed to demonstrate the monetary value of standards, conformity assessment and accreditation for businesses. The website represents another successful collaboration of the INetQI partners with over 95 case studies categorised into 6 areas of value. All of the case studies identify a clear financial benefit. The site also includes more than 75 research papers.

ILAC Membership 

The ILAC membership as of 30 April 2024 is:

  • 114 Full Members (signatories to the ILAC MRA) representing 116 economies;
  • 17 Associates representing 19 economies;
  • 20 Stakeholders;
  • 6 Recognised Regional Cooperation Bodies

The ILAC membership consists of 155 organisations from 130 different economies worldwide. Signatories represent about 95% of Global GDP. Over 76,000 laboratories, 10,500 inspection bodies, 400 PTP and 30 RMP are accredited by the ILAC Full Members (signatories to the ILAC MRA).The latest statistics and graphs on the number of accreditation bodies, accredited laboratories, inspection bodies, PTPs and RMPs are available from the ILAC Facts & Figures page.

Establishment of a Single International Organisation for Accreditation

Work commenced on the IAF-ILAC Single Organization Project on 1 March 2021 to establish a Single International Organisation for Accreditation in accordance with the 2019 JGA Frankfurt Resolutions. The contractor managing this process is Dr.-Ing. Thomas Facklam.

The contractor is currently working closely with the Joint Steering Committee on various tasks associated with this project and in 2022 both the ILAC Extraordinary GA and the IAF/ILAC JGA focused on topics associated with this project.

ILAC Meetings 

The Mid Term meetings were held virtually during April 2024 and were well attended. Minutes are currently being finalised and will be distributed to the various Committee members in due course. The virtual management of these meeting was once again provided by Say Something Communications

The IAF/ILAC annual meetings will be held in-person in Berlin, Germany from 1 – 10 October 2024. Further information on the meetings, and registration details, will be provided once the schedule

In addition to the meetings noted above all ILAC Committees, Working Groups and Task Forces continue to progress the items on their work plans via a combination of email and remote meetings.

ILAC Liaisons and other International Activities 

The current list of ILAC liaison activities includes:

ILAC Liaisons with ISO and ISO/CASCO Policy Committees

  • ISO-IAF-ILAC JSG (Joint Strategic Group)
  • ISO/CASCO Plenary
  • ISO/CASCO CPC (Chairman’s Policy Committee)
  • ISO/CASCO STAR (Strategic Alliance and Regulatory Group)
  • ISO/CASCO TIG (Technical Interface Group)
  • ISO/CASCO TIG -Technical Expert Group (TEG)
  • ISO TC 69/ SC6 (Application of statistical methods)
  • ISO TC 176 (Quality Management & Quality Assurance)
  • ISO TC 212 Plenary (Clinical Laboratory Testing and In-Vitro Diagnostic Systems) and WG1 (ISO 15189)
  • ISO TC 272 WGs 1-5 (Forensic Sciences)
  • ISO TC 276 WG2 (Biobanking)
  • ISO TC 334 (Reference Materials – formerly ISO/REMCO)

    ILAC Liaisons with ISO/CASCO Working Groups/Task Forces

    • ISO/CASCO CPC TG Future of CASCO Toolbox
    • ISO/CASCO WG 31, Revision of ISO/IEC 17020
    • ISO/CASCO WG 57 Revision of ISO/IEC 17043
    • ISO/CASCO WG 61, Revision of ISO/IEC 17012

    ILAC Liaisons with Other Organisations

    • BIPM-ILAC WG Bipartite
    • BIPM-ILAC-ISO-OIML Quadripartite
    • OIML-CS Management Committee (MC)
    • Meeting of Signatories to the Joint Statement on the Digitalization
    • CITAC (Cooperation on International Traceability in Analytical Chemistry)
    • EUROLAB Conference
    • IEC/IECEE International Electro-technical Commission (ILAC-IAF-IEC Steering Committee)
    • INetQI International Network on Quality Infrastructure
    • JCGM Joint Committee for Guides in Metrology Plenary and WGs 1 (GUM) and 2 (VIM)
    • JCTLM Joint Committee on Traceability in Laboratory Medicine
    • ITU International Telecommunication Union
    • OECD Organisation for Economic Cooperation and Development
    • UNECE-WP6- Metrological recommendations
    • WADA World Anti-Doping Agency

     

    Information on ILAC’s partnerships, including copies of communiqués, joint procedures, press releases and MoUs, is available from the ILAC Partnerships page.

    ILAC thanks all of the ILAC liaison officers, and their organisations, who volunteer their time to assist ILAC in carrying out these activities for the benefit of all ILAC members.

    ILAC Secretariat

    The new ILAC Secretariat staff commenced work on 1 January 2024.

      • Michael Fraser – ILAC Secretary
      • Johanna Acuna – ILAC Arrangement Program Manager
      • Belinda Mort – Marketing and Communications Manager, Finance Administrator
      • Wanji Yang – Technical Committee Program Manager, ILAC Administrator
      • Rose De Rota – Member Services
      • Nonlanhla (Nyaki) Halimana – Joint Development Support Program, Member Services
      • Paul Smith – Finance Officer
      • Karla Sanchez – Social Media Coordinator (job share with IAF)
      • Krista Eager – Marketing Coordinator (job share with IAF)

     

    The new staff wishes to acknowledge and thank the former Secretariat staff – Annette Dever, Sharon Kelly, Hannah Yeoh, Stephanie Sun, and Joelle Nicolas.

    Documents and Brochures

    The following publication has been finalised and released since October 2023: 

    • ILAC P5:11/2023 ILAC Mutual Recognition Arrangement: Scope and Obligations
    • ILAC P8:11/2023 ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Conformity Assessment Bodies
    • ILAC R6:11/2023 Structure of the ILAC Mutual Recognition Arrangement and Procedure for Expansion of the Scope of the ILAC Arrangement
    • ILAC P9:01/2024 ILAC Policy for Proficiency Testing and/or Interlaboratory comparisons other than Proficiency Testing
    • ILAC G18:01/2024 Guideline for describing Scopes of Accreditation
    • IAF – ILAC Handbook
    • Follow @ILAC_Official on “X”(formerly Twitter) to receive the latest ILAC news, including information on meetings, events, liaison activities and new publications.

      Subscribe to the latest news to receive updates from ILAC members and liaisons.

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EUROLAB Update

The European Federation of National Associations of Measurement, Testing and Analytical Laboratories (EUROLAB) is glad to share three updates on key activities and initiatives.

ANNUAL REPORT 2023

EUROLAB has published its Annual Report 2023 which includes an overview of EUROLAB’s most notable achievements and landmark events for last year, with details on the current and future activities, international collaborations, projects of interest to laboratories and the latest news from the Technical Committee on Quality Assurance.
The document summarises EUROLAB’s involvement in the laboratory community and the cooperation with the members and stakeholders.
EUROLAB would like to thank all its members and stakeholders for the fruitful collaboration in 2023 and looks forward to continuing enhancing joint cooperation opportunities in the future.

The Annual Report is available on EUROLAB’s website.


EUROLAB GENERAL ASSEMBLY IN VIENNA
EUROLAB General Assembly & Accompanying Events, will took place on 17- 19 April 2024 in Vienna (Austria) at the Austrian Standards Institute, kindly hosted by AUSTROLAB.
The meetings represented an important occasion to discuss face to face the latest key issues, projects and key priorities for EUROLAB and the world of laboratories, and further engage with the members and the local laboratory community.

EUROLAB JOINS THE LABSUMMIT® 2024 AS INSTITUTIONAL SPONSOR

EUROLAB is one of the institutional sponsors of the Labsummit® 2024, taking place on 16-18 May 2024 in Coimbra (Portugal), jointly organised by RELACRE, ISQ and Ambidata.

The international event will feature 1000 attendees and host more than 30 exhibitors with more than 100 sessions. Its aim is to bring together professionals from the laboratory industry, scientists and policy makers, managers and administrators, students, and all those interested in discussing the latest trends, technologies, and challenges of the present and future in the field of laboratories.

The Labsummit® aims to promote an inspiring environment where participants can update themselves, share knowledge, establish partnerships, and drive the advancement of the laboratory industry. It focuses on four distinct pillars – Laboratory, Digital, Productivity, and Sustainability – which represent the main concerns and challenges faced by laboratory professionals who are constantly seeking valuable solutions and information to improve the efficiency, quality, and sustainability of laboratory processes.

Furthermore, the event will feature exhibitors, workshops, expert lecturers, successful case presentations and panel discussions. Amongst the various high-level speakers, EUROLAB will be represented by the President, Mr Paolo Moscatti who will be participating as a speaker in the Labsummit®.

All these different activities together offer a big opportunity of networking and interaction between different realities and work environments that cannot be missed.

Further information on the event is available here
For registration, click here

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