EDMA - 28th General Assemblay
Minutes of the 28th General Assembly
31st October 2007, 09.30 – 15.30
Hotel Sheraton Airport, Brussels
Participants
See participants’ list on the EDMA website (address below).
Absent members
NAMs
AFPM (Romania), BTMA (Bulgaria), FENIN (Spain), HIVDA (Hungary), IMDA
Ireland), NLF (Norway), ODGH (Austria), Swedish Labtech (Sweden) and Tani IVD (Turkey).
CAMs
BioSystems, Chiron, Cytyc, Find, Innogenetics, Instrumentation Laboratory, Lifescan, Luminex, Mallinckrodt Baker, Ortho Clinical Diagnostics, Randox Laboratories, Tecan and Tosoh Bioscience.
For details on the presentations and other items on the agenda, please see the EDMA website “Members Only / General Assembly”
(http://www.edma-ivd.be/index.php?id=ga)
378. Welcome
EDMA President Jean-François de Lavison welcomed all participants to the EDMA 28th General Assembly. Participants introduced themselves in a tour de table.
379. Approval of previous minutes
The minutes of the 27th General Assembly received no comments and were approved.
380. Approval of annual report on EDMA activities
n Achievements since last year
The Director General of EDMA Christine Tarrajat presented a report on the activities of EDMA in 2007. EDMA CAM membership has more than doubled with four new members joining in 2006: Cellestis, Chiron, Genzyme and Tosoh; and 12 new members joining in 2007: Arkray, Biosystems, FIND Diagnostics, Innogenetics, Luminex, Mallinkrodt Baker, MLT Research, Orion Diagnostica, Randox, Siemens Medical Solutions, Stago and Tecan. EDMA also increased its NAM membership as TANI-IVD from Turkey joined EDMA in 2007. In order to realise the EDMA objective to get closer to its members by increased collaboration with NAMs and CAMs there had been numerous visits by EDMA staff to EDMA members. Contacts included attendance at conferences and events organised by EDMA members as well as further expansion of the participation in MedicalLab and Lab Tests Online projects. EDMA achievements also included Communicating EDMA thorough; the EDMA website, the EDMA News Update, a new set of EDMA brochures, discussion forums and workshops and making information available in the form of Regulatory News, Guidance and Q&A documents. The goal of representing the industry’s viewpoint was achieved by regular attendance to European Commission meetings and active involvement in the development of guidance, regular participation in ongoing political and legislative processes and positioning the IVD sector in relation to the Health Programmes of the EU Presidencies. Furthermore the network of contacts in the EU Institutions, International Organisations and Scientific Societies has been expanded. Other activities included promoting the value of IVDs through Key Messages and Fact Sheets and producing the IVD Market Estimates as well as achieving international recognition in key markets.
EDMA President Jean-François de Lavison gave the new members present the opportunity to make a short introduction about their organisations and five ‘new’ members representatives from Arkray, MLT Research, Orion Diagnostica, Siemens Medical Solutions and Stago gave a brief description of their companies.
EDMA President Jean-François de Lavison congratulated the EDMA staff on their achievements and reminded the meeting how much EDMA’s situation had improved in the last years.
The annual report was unanimously approved by the meeting.
381. Auditors’ reports
n Approval of External Auditors’ report
Christine Tarrajat presented the conclusions from the External Auditors’ report (Ernst & Young), which demonstrates that the accounts truly reflect the EDMA’s financial position and assets at December 31, 2006.
The External Auditors’ report was approved by the meeting.
n Approval of Internal Auditors’ report
The report was presented by George Zajicek (BIVDA), together with Frank Hes (DIAGNED), who performed the internal audit.
George Zajicek pointed out the important increase of EDMA membership these last two years (31 CAMs and 21 NAMs, Turkey was a recent recruit) and the very good financial situation due to exceptional income, extra membership and review of banking policy regarding interest on deposits. In conclusion, the auditors were “very pleased to see the progress of EDMA and its very efficient Secretariat – the challenge remaining to ensure all levels of membership are aware of what EDMA has achieved and what it continues to offer”.
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The Internal Auditors’ report was approved by the meeting.
n Election of Internal Auditor
The internal auditors are appointed for 4 years.
George Zajicek (BIVDA) was elected in June 2005 and will continue for 2 more years.
A new auditor had to be elected to replace Frank Hes (DIAGNED), whose term of appointment has expired.
Christine Tarrajat expressed her thanks for the time and dedication that Frank Hes put during his four years mandate and wished him all the best for the future.
Carlos Sisternas (FENIN) was elected unanimously, replacing Frank Hes.
382. Treasurer’s report
n Budget 2007: To date 9 months
The Treasurer Benny Ons presented the results of the first 9 months 2007, with a revised budget for 2007. The revised forecast shows a very good positive result (income less expenses to be (+)266,097 euro, instead of (+)3,000 euro in the 2006 March forecast).
n Budget 2008 / Forecast 2009:
The 2008 budget was approved.
The 2009 forecast was also presented by the treasurer.
Following the good financial result, the Executive Committee decided no increase in membership fees for 2008.
383. Elections of members of the Executive Committee
The Executive Committee is constituted by 4 CAMs and 6 NAMs, elected for 2 years.
n Election of Executive Committee members by CAMs
The President informed the General Assembly of the results of the ACAM votes.
This year the ACAM had to elect three members for the Executive Committee.
Jaime Contreras (Abbott), Jean-François de Lavison (bioMérieux) and Jürgen Schwiezer (Roche) have been elected by the ACAM.
n Election of Executive Committee members by NAMs
This year the NAMs had to elect three members. The three candidates, Benny Ons (BD) - PHARMA.be, Jürgen Schulze (Sysmex) - VDGH and Hans Hostettler (Beckman Coulter) - SVDI/ASID were presented to the meeting and were unanimously elected.
n Election of Executive Committee officers
Jean-François de Lavison (bioMérieux) was re-elected as President, and Jaime Contreras (Abbott) and Jürgen Schulze (Sysmex) - VDGH as Vice Presidents.
384. Collaboration with JACRI
Hisashi Ietsugu, JACRI Chairman introduced the association and thanked EDMA for the invitation. IVD Reagent Market and Healthcare and Medical care Systems in Japan was presented by Kenichi Yukimoto, JACRI Permanent Director. Hirofumi Koide, JACRI Managing Director presented the Mission and Organisation of the Association as well as the Achievements of JACRI in 2005-2007.
385. Report from Regulatory Affairs Committee
The Report from the Regulatory Affairs Committee was given by Benny Ons, EDMA Treasurer and Chair of the Regulatory Affairs Committee. The objectives are to support an appropriate regulation system and to be an effective voice in globalisation. In order to achieve this, the work processes of the committee include consensus building through working group meetings, representing industry view through consultations, position papers and meeting with stakeholders; as well as making information available.
386. Any Other Business
n Communications activities
At the request of EDMA President Jean-François de Lavison EDMA’s communication Manager Gloria Galan presented the recently released EDMA brochure. All NAMs are invited to translate and adapt the brochure. Further copies are available from EDMA office. She also introduced the Lab Test Online launch which will take place on Thursday 31st January 2008.
387. Conclusions and date of the next meeting
The date of the next meeting will be on 26th June 2008 preceded by a Strategic Committee on 25th June 2007.