2nd edition

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.

1000€ 

Theme

Focus on performance evaluation

Networking

A friendly evening to encourage exchanges between participants

Round table

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

Welcome

By Florent Guyon (nexialist)

14h10 – 15h15

One month after the date of application, what is the situation ?

By SIDIV

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

Networking event

Round table : How to support medical device companies in their market access efforts 

Buffet

Wednesday, June the 29th

8h30 – 9h

Welcome Coffee

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)

Speakers

They’ll be with us

Carlos Galamba

Vice President, IVD Intelligence and Innovation at RQM+

Carlos Galamba joined RQM+ in 2021 in the role of Vice President Intelligence & Innovation where he is responsible overall strategic direction and subject matter leadership for diagnostics.
Before RQM+, Carlos was at BSI for 7 years where he was responsible for managing, coaching, and developing a global team of IVD technical experts. Among many of Carlos’s achievements he was BSI’s first in-house clinician for IVDs where he led the implementation of the BSI clinical oversight process, made hundreds of CE marking recommendations for IVDs and supported IVDR Notified Body designations.
Prior to BSI, Carlos has held roles at the UK competent authority, the MHRA and was a lead scientist in the UK National Health System specialising in transfusion and transplantation medicine. He was also at the forefront of the Ebola crisis in 2014 when the first cases were detected in Europe, playing a key role in hospital and laboratory preparedness for emerging infectious diseases.

cgalamba@rqmplus.com

https://www.rqmplus.com

Corinne Delorme

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. 

c.delorme@nexialist.fr

https://nexialist.fr/en/corinne-delorme-2

Erica Conway

Head of Notified Body – IVD at BSI

Erica has 20 years Regulatory Affairs experience within Pharmaceuticals, CRO and latterly IVD medical devices.
 
Following a BSc (Hons), PhD (Neurophysiology) and Post-doc, Erica’s industrial experience started at GSK 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 IVDs when she became the Regulatory Affairs Manager for Axis-Shield Diagnostics (now Alere). She then went into performing independent consultancy work and continued working within the IVD and medical device field, as a continued member of BIVDA. Erica worked for a small start-up IVD company prior to joining BSI, where she set up a Quality Management System to ISO 13485 and ISO 17025.
Erica joined BSI at the beginning of 2014, and is now Global Head of IVDs, using her experience to transition the Notified Body to the IVD Regulation.

Erica.Conway@bsigroup.com

https://www.bsigroup.com

Jeannette Fareh

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.

Jeannette.Fareh@lne-gmed.com

https://lne-gmed.com

Dr Julien Senac

Julien Senac

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.

Julien.Senac@tuvsud.com

https://www.tuvsud.com/en

Laurence Matheron

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).

laurencematheron@lmmd-consulting.com

https://www.linkedin.com/in/laurencematheron

Dr Julien Senac

Richard Houlihan

CEO of EirMed Ltd

Richard Houlihan is an international speaker on EUDAMED. His time running the IT teams developing EUDAMED in the European Commission have given him unrivalled insights into how it affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED.

richard.houlihan@eudamed.com

http://Eudamed.com

Robyn Meurant

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.

robyn@act-ivd.com

https://www.linkedin.com/in/robyn-meurant-act-ivd

Dr Julien Senac

Sophie Chassaigne

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.

A venir

https://www.biomerieux.fr

Dr Julien Senac

Sophie La

Manager Qualité et Affaires règlementaires chez Theradiag

Diplôme d’ingénieur en biologie
1e expériences professionnelles en Assurance Qualité (notamment 6 mois chez Servier)
Puis 6 ans chez STAGO en Affaires réglementaires en tant chargée d’enregistrements puis responsable d’équipe enregistrements
5 ans en AQAR dans le domaine de la chimie aéronautique au sein d’une PME – réglementation biocide, REACH, CLP, aérosol et normes aéronautiques (Boeing, Airbus) pour évaluer la compatibilité des matériaux de l’avion avec les produits
Depuis Aout 2020 chez Theradiag en charge toute la partie Qualité/réglementaire

sla@theradiag.com

https://www.theradiag.com

Steve Lee

Director, Diagnostics Regulation at ABHI Groups

Steve joined ABHI as Director of Diagnostics Regulation in 2020.
After completing his degree in Biochemistry and Biology at Aston University, Steve trained as a Biomedical Scientist, working in hospital microbiology before moving to industry to work as company microbiologist. Steve joined MHRA in 1996 when it was still the Medical Devices Agency and when the IVD Directive had yet to be implemented.
While at MHRA, Steve worked with manufacturers, Notified Bodies, other Competent Authorities, Trade Associations, standards bodies and government departments. Steve was Chair of the European Commission’s IVD working group when the IVD regulations where being developed.
In 2019, Steve was presented with the TOPRA award for regulatory excellence.

Stephen.Lee@abhi.org.uk

https://www.abhi.org.uk/who-we-are/our-organisation/abhi-staff/steve-lee

Contact

Book my place

To book your place, nothing could be easier. Fill out the form or contact us at this email address : rdvdudiv@nexialist.fr

Phone

04 42 01 60 29

Don’t miss the must-attend event for DIV contributor

thecamp

550 Rue Denis Papin
13100 Aix-en-Provence, France
See on maps

 

Contact us

rdvdudiv@nexialist.fr

04 42 01 60 29