Le RDV du DIV
28th & 29th June 2022
Regulation (EU) 2017/746:
Focus on Performance Evaluation
The event for all IVD stakeholders is back for a second edition. This year, the event will take place over two days, on June 28 & 29. it will bring together all sector players (manufacturers, NB, CA…) in a convivial and favorable framework of exchanges.
Focus on performance evaluation
A friendly evening to encourage exchanges between participants
Feedback from 3 notified bodies and 3 IVD manufacturers
Not only one but two days !
A program focused on Performance Evaluation
Because last year edition was too short, this year the RDV du DIV will take place over two days with a networking event first evening.
Don’t come alone! Each additional registration will benefit a 50€ discount. This discount is cumulative with early bird offer.
Tuesday, June the 28th
13h30 – 14h
Opening & Coffee
14h – 14h10
By Florent Guyon (nexialist)
14h10 – 15h15
One month after the date of application, what is the situation ?
15h15 – 16h
EUDAMED, the latest and experiences so far
By Richard Houlihan (EirMed Ltd)
16h – 16h30
Break and exchanges
16h30 – 17h15
Legacy product: take advantage of transitional provisions!
By Corinne Delorme (nexialist)
17h15 – 18h
State of the Art : Importance & impact on technical documentation
By Laurence Matheron (Lmmd consulting)
18h – 22h
Round table : How to support medical device companies in their market access efforts
With Mme Spinardi (DGE), Catherine Holtzmann (LNE-GMED), Salim Saïfi (eurobiomed), Julien Senac (TUV SUD) and Vincent Casteras (nexialist)
Wednesday, June the 29th
8h30 – 9h
9h – 9h40
Do manufacturers really understand the intent of a performance evaluation?
By Robyn Meurant (ACT-IVD)
9h40 – 10h20
Establishing clinical correlation: Scientific Validity in IVDR
By Steve Lee (ABHI)
10h20 – 10h45
Break & Discussions
10h45 – 11h25
Uncovering Post-Market Performance Follow-Up: challenges, lessons learned and opportunities
By Carlos Galamba (RQM+)
11h25 – 12h30
Feedback from manufacturers: impact of IVDR Performance Evaluation requirements
By Sophie Chassaigne (bioMérieux), Sophie La (Theradiag) & Sophie Réhaut (Stago)
12h30 – 14h
Lunch & Discussions
14h – 16h
Feedback from notified bodies : lessons learnt about performance evaluation conformity assessment
With Julien Sénac (TUV Sud), Jeannette Fareh (GMED) & Erica Conway (BSI)
They’ll be with us
Vice President, IVD Intelligence and Innovation at RQM+
Regulatory Intelligence Director at nexialist
Corinne Delorme is Regulatory Intelligence Director at nexialist.
Her current position and her previous operational and management positions within French Ministry of Health and a MD notified body forge her regulatory convictions and her understanding of the MD sector.
She has been particularly involved in the implementation of medical device regulations in Europe, US, Canada, Australia, Brazil, Japan and Taiwan.
She is an active member of the AFNOR S95B Commission « Quality Management and Related General Aspects of Medical Devices » and of the associated CEN and/or ISO standards working groups.
She is a member of the Advisory Board of the association Team PRRC.
Very fond about knowledge transmission, she also develops training sessions and webinars.
Head of Notified Body – IVD at BSI
Erica has over 20 years experience in the In Vitro Diagnostic (IVD) medical device and pharmaceutical industries, within Regulatory Affairs and Quality Assurance. Following a BSc (Hons), PhD (Neurophysiology) and Post-doctoral research, Erica’s industrial experience started at GlaxoSmithKline in the regulation of pharmaceuticals. Further she worked in the arena of clinical trials for medicinal products for Quintiles. Erica then moved into the field of IVD medical devices when she became the Regulatory Affairs Manager for Axis-Shield Diagnostics (Alere Toxicology; now Abbott). She then went into performing independent consultancy work and continued working within the IVD and medical device field, as a continued member of British IVD Association, prior to joining BSI.
Erica joined BSI at the beginning of 2014 as a Technical Specialist/Scheme Manager in the IVD medical devices team. She took the position of Global Head of the IVD Medical Device Team in May 2016, to lead the IVD Technical team through transition of the Notified Body (NB) to the new EU IVD Regulation, leading to the successful designations of BSI UK and BSI NL NBs. Erica has since been leading the IVD Technical team for operational delivery of Technical Documentation assessments and expanding the team to meet the increased resource demands under the IVDR. Erica moved into the position of Head of NB – IVD in Oct 2021 and continues to represent the NB on Team NB/NBCG-Med for IVDs.
Product Reviewer, Internal Clinician at GMED
Le Dr Jeannette Fareh a rejoint GMED en septembre 2020 et a été qualifiée en tant qu’Examinateur de produits et clinicien interne. Elle travaille au sein de la branche Certification du GMED pour le département des dispositifs médicaux de diagnostic in vitro. Le Dr Fareh a débuté sa carrière en tant que directrice de recherche chez Angiogene Inc (AccelLab) au Canada après deux post-doctorats dans la prévention et le traitement des maladies cardiovasculaires grâce à de nombreux prix (Merck, Conseil de recherches médicales du Canada, Société de recherche sur les maladies du cœur du Canada, Société canadienne d’hypertension artérielle, Programme Lavoisier). Après 10 ans au Canada, le Dr Fareh a rejoint Bio-Rad Laboratories pour 14 ans en tant que responsable R&D dans l’unité Biomarqueurs dédiée à l’innovation dans le diagnostic des maladies métaboliques, chroniques et infectieuses. Le Dr Fareh a été le principal investigateur de programmes de recherche collaborative nationaux et internationaux dans le domaine du diagnostic clinique ; elle participe à des comités scientifiques et cliniques et enseigne en Master 2 dans le domaine du diagnostic innovant. Le Dr Fareh est titulaire d’un doctorat en physiologie/biologie de l’Université Claude Bernard de Lyon I et d’une Habilitation à Diriger les recherches (HDR) de l’Université de Médecine de Montpellier.
Global Director of the IVD Focus Team at TÜV SÜD
Dr. Julien Senac is currently Global Director of the IVD Focus Team at TÜV SÜD, overlooking the development of IVD field and in particular IVDR. Prior to this, he has many years of experience with a certification body, where he participated to the preparation of IVDR designation, and performed Design Dossier assessment of in vitro diagnostic devices. Dr Senac has a Ph.D. in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr Senac has also participated to the development of multiple biotech start-up companies in oncology and gene therapy.
Freelance consultant chez lmmd consulting
Laurence Matheron has over 15 years’ experience in European medical device and in vitro diagnostic device regulation. Her expertise includes economic operator strategies, EUDAMED planning, transition strategy development, classification decisions, BREXIT impact assessments, technical documentation and quality management system procedures gap assessments, and training.
Dr. Matheron previously worked at the UK Medicines and Healthcare products Regulatory Agency (MHRA) leading a European project on medical device market surveillance. She also served as the Head of the Department of Consumer Medical Devices and Cosmetics at the French Agency for Medicines and Health Products Safety (ANSM). Earlier, at the French Health Products Safety Agency (AFSSAPS), she headed a team in charge of vigilance for in vitro diagnostic medical devices. She also worked in health technology assessment as a project leader in the Department of Medical Device Assessment in the French National Authority for Health (HAS).
CEO of EirMed Ltd
Principal consultant at ACT-IVD
Expert in IVD regulatory assessment. Extensive experience in regulation. Strong knowledge of IVDR and how to effectively implement it. Ms Meurant was the regulator of IVDs for the Australian Therapeutic Goods Administration, led technical documentation assessment and guidance development for WHO PQ, was the global lead for IVDXsat NSF Health Sciences, and has been advising governments and NGOs during the COVID-19 pandemic. She has also extensive experience in regulatory capacity building. She commenced her career as a diagnostic scientist, heading the serology laboratories of several of the largest pathology providers in Australia.
Business Process Referent at bioMérieux
PharmD with a master degree on Regulatory Affairs (Lyon I). First experience within GSK Vaccines in Bruxelles as RA Specialist in the Compliance Team. I joined bioMérieux in 2015 as a RA Specialist in RA Market Team (Asia area – including China) to obtain and maintain registrations of IVD Devices in the countries concerned. Then, I moved to a CA/RA Transversal Team (Support Office) as Project Leader. I had opportunity to lead various projects (development of IS tool & change management) and am now in charge of the bioMérieux IVDR Transition Plan.
Manager Qualité et Affaires règlementaires chez Theradiag
Director, Diagnostics Regulation chez ABHI Groups
QMS lead auditor
Catherine Holzmann has worked in the in vitro diagnostic medical devices field for over 25 years and is currently the In Vitro Diagnostics Medical Device department manager of the Medical Devices Certification Department of LNE/G-MED (Laboratoire National de métrologie et d’Essais), a position she has held since 2006. LNE is an important testing laboratory that has many activities in different sectors. Specific to IVDs, G-MED carries out missions and provides services to manufacturers as the French notified body (0459 – website lne-gmed.com).
She began her career as a marketing manager at Sanofi Diagnostics Pasteur and then lead her career to regulatory affairs position at Bio-Rad Laboratories. She was graduated Doctor in Pharmacy in 1985 and received a PhD from internship in Biology in Paris in 1989.
Catherine is a qualified QMS lead auditor, a product specialist and she also develops training sessions and conferences
Cheffe de projet santé – Direction Générale des Entreprises – Ministère de l’Économie, des Finances et de la Souveraineté industrielle et numérique
Diplômée en management des affaires internationales et en management des industries de santé, Roxane Spinardi a occupé différentes fonctions de marketing & accès au marché, de stratégie, ou encore d’organisation pendant près de 20 ans dans l’industrie, dont 10 passés dans l’industrie de santé, avant de rejoindre la DGE pour participer au déploiement du plan d’investissement France 2030, notamment du volet soutien à la filière des dispositifs médicaux pour développer et produire les dispositifs médicaux de demain.
Au sein de l’équipe santé de la DGE, elle pilote, entre autres projets, les travaux interministériels relatifs à ce volet dispositifs médicaux de France 2030.
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