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Event Date |
Mon Jun 19 EEST - Fri Jun 23 EEST (over 1 year ago)
In your timezone (EST): Sun Jun 18 5:00pm - Thu Jun 22 5:00pm |
Location |
Sheraton Brussels Airport Hotel
Brussels Airport, 1930 Brussel, BE |
Region | EMEA |
The summit will be covering EU MDR/IVDR, Clinical Investigations, Post-Market Surveillance, Software/AI, Biocompatibility, Law & Compliance, and Global Market Access.
2023 Speakers
Fayez Abou Hamad
MD Vigilance Expert Consultant – Pharmacist, Terumo Europe N.V., Belgium
Shweta Agarwal
Regulatory & Safety Specialist, EY
Bassil Akra
CEO, Akra Team Gmbh
Eljar Amini-Nejad
Senior Consultant Medical Devices and IVDs, NSF
Stuart Angell
Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
Silvia Anghel
Associate Director and Head of IVD Group, Medidee
Andrew Austin
Partner, Global Co-Head of Consumer & Healthcare, Freshfields Bruckhaus Deringer
Jaklin Aziz
Senior Manager – Global Post Market Surveillance, Resmed
Sabrina Aït Allek
Quality Assurance & Regulatory Affairs Director, Stilla Technologies
Pat Baird
Senior Regulatory Specialist, Philips
Natasha Bankowski
Director of Regulatory Affairs and Quality Assurance, Beyond Air
Khaudeja Bano
VP, Combination Product Quality, Amgen
Ashleigh Batchen
Head of Regulatory Affairs, British In Vitro Diagnostic Association (BIVDA)
Stephanie Berger
PMS EUMDR Lead - PMS Process and Governance, Philips Healthcare, Germany
Jón Bergsteinsson
Founder & Director of EMEA Sales, SMART-TRIAL by Greenlight Guru
Priya Bhutani
CEO, RegDesk
Alpa Bhuva
Director, Post Market Quality, Bristol Myers Squibb
Wojciech Bobela
Clinical Affairs Manager, Ziemer Ophthalmic Systems AG
Daniele Bollati
Product Conformity Assessment, IMQ
Margot Borgel
Director, IVD Intelligence & Innovation, RQM+
Gert Bos
Executive Director & Partner, Qserve Group
Elvan Sevi Bozoglu
Partner, Bozoglu Izgi Attorney Partnership
Petr Brat'ka
Preclinical Evaluation Manager, Czech Metrology Institute
Ron Brown
Director and Principal Toxicologist, Risk Science Consortium, LLC
Iván Calderón
Executive Director of Marketing Authorisations and Establishments, COFEPRIS
Carla Cambiano
Biomedical Engineer, Italian Ministry of Health - Directorate General of Medical Devices and Pharmaceutical Service
Claudia Carbonell
Senior QA/RA Manager, Methinks
Giacomo Cargnello
Head of Quality & Regulatory, Connect&Control Solutions, Varex Imaging
Marta Carnielli
Head of Certification IVD, TÜV SÜD Product Service GmbH
Nate Carrington
Vice President of Global Regulatory Affairs, Global Quality and Regulatory Affairs, Agilent Technologies
Ana Luiza Cassin Duz
Clinical Manager, Mediphacos
Rea Castro
Director of Medical Affairs, QuidelOrtho
Alex Charitou
Partner, MedTech Lead, EY
Oliver Christ
Senior Director Health Science EMEA, NSF
Sophie Clewlow
Biological Safety Assessor, MHRA
Koen Cobbaert
Senior Manager - Quality, Standards & Regulations, Philips
Carine Cochereau
VP International Regulatory Affairs, Integra LifeSciences
Naama Cohen-Dahan
Senior Clinical Development Scientist, Clinical Affairs, CT BU, Philips
Juliette Cook
Vice President Regulatory Affairs & Quality,Implantica, Marco Costante
Group Leader
Human Health, Environmental & Human Toxicology, Knoell Germany GmbH
Sarah Cowlishaw
Partner, Covington & Burling LLP
Demi Dabor-Alloh
Manager, MedTech & Life Sciences, EY
Auindrila Das
Head of Regulatory Affairs Abbott (Jena GmbH), Abbott
Debashis Dash
Engineering Manager, Medtronic
Rich de la Cruz
Principal Consultant Quality and Software, Silver Lake Group, Inc
Maria de la Luz Lara Méndez
CEO, Udelá
Daniel Delfosse
Executive Board Member, Director Regulatory Affairs, Swiss Medtech
Nataliya Deych
Vice President Regulatory Affairs EMEA, Latam, Canada, Edwards Lifesciences
Boopathy Dhanapal
Convenor of WG18, ISO/TC 194, ISO
Melanie Donguy
Head of Regulatory Affairs, Bayer
Leon Doorn
Head of Regulatory Compliance, Aidence
Susanne Dorn
European Registered Toxicologist (DGPT), Environmental & Human Toxicology, knoell Germany GmbH
Crystal D’Silva
Manager, Pre-Clinical Toxicology – Global Quality, Baxter
Steve Eglem
Head of Clinical Investigation Unit, FAMHP
David Einum
Principal Biocompatibility Scientist, W.L. Gore & Associates
Jörg Engelbergs
Scientific-Regulatory Expert Targeted & Personalized Biomedicines
Paul-Ehrlich-Institut
Igor Excelmans, Digital Health Expert, QbD
Queenita Fernandes, BHMS, DND, CCH, CPPS
Senior Medical Safety Manager, Medical Surgical, Medtronic
Patrick Fivey
Director of Precision Medicine Policy, AstraZeneca
Paul Fletcher-Dyer
Compliance Director & DPO, Cognetivity Ltd
Alice Forde
Director, Regulatory Affairs Europe - Medical Devices, Bausch & Lomb
Andy Forreryd
Key Account Manager & Scientific Liason, SenzaGen
James Gallagher
Partner, Mason Hayes & Curran LLP
Raj Gathani
Associate, Covington & Burling LLP
Elizabeth Gfoeller
Corporate Director, Regulatory Affairs, MED-EL
James Gianoutsos
CEO, Rimsys
Stephen Gilbert
Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Flora Giorgio
Acting Head of Unit, D.3 Medical Devices, DG SANTE, European Commission
Liz Gommans
Technical Professional, DEKRA
Monica Grekula
Director Biocompatibility and Toxicology, Limulus Bio AB (Now part of Veranex)
Laura Gámez Santín
Head Medical Device Vigilance, Novartis
Chems Hachani
CEO, Eclevar
Harriet Hanks
Counsel, Freshfields Bruckhaus Deringer
Elizabeth Harrison
Global Head – IVD Medical Devices, BSI
Oliver Hartmann
Legal and Regulatory Affairs Manager, Association of the European Self-Care Industry (AESGP)
Martina Hayes
Medical Device and IVD Manager, Pharmalex
Ella Helgeman
Director, Regulatory Affairs and Quality Assurance, Nowwell AS
Eric Henry
Senior Quality Systems and Compliance Advisor, King & Spalding
Catherine Holzmann
IVDMD Department Manager - GMED Certification Division - France, LNE/G-MED
Richard Houlihan
CEO, EirMed
Leo Hovestadt
Director Governmental Affairs EU, Elekta, The Netherlands
Amelia Hufford
Senior Vice President, Clinical and Regulatory Science Operations, 3Aware
Karin Hughes
Senior Vice President Global Regulatory & Quality, Beaufort
Daniel Jacob
VP Medical Device Vigilance & GPS Quality System, Baxter
Shelley Jambresic
Senior Clinical Evaluation Manager, Geistlich Pharma AG
Pall Johannesson
Managing Director, SMART-TRIAL by Greenlight Guru
Hilary Jones
Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
Ulrich Juknat
Legal Director – Regulatory Law, Johnson & Johnson
Marika Kamberi
Sr. Director Analytical Chemistry and Biocompatibility, Abbott Medical Devices
Nelli Karhu
Senior Inspector, Section Head, Finnish Medicines Agency Fimea
Adam Kijowski
Clinical Compliance Manager, Geistlich Pharma AG
Dominik Kowalski
Project Manager / Regulatory Compliance / IEC Standard Member for AI and Radiotherapy, Brainlab
Nadège Krebs, PhD
Customer Consultant Embase, Elsevier
Bunty Kundnani
Head of Regulatory Affairs, Qure.ai
Jaishankar Kutty
Vice President, Intelligence and Innovation, RQM+
Zuzanna Kwade
Clinical Evaluation Lead, Dedalus HealthCare
Joseph-Richardson Larbi
Regulatory Affairs Expert – Medical Devices, Celegence, Celegence
Jeppe Larsen
Director of Medical Devices, Danish Medicines Agency
Steve Lee
Director, Diagnostics Regulation, Association of British HealthTech Industries (ABHI)
Mira Leiwant
Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance, Anika Therapeutics, Inc.
Laura Liguori
Partner, Portolano Cavallo
Bianca Lutters
Head of Clinical Operations, Qserve Group B.V
Ivo Machatschke
Team Leader, Clinical Evaluations, R&D Signal Processing & Fitting, MED-EL
Celeste Maksim
Head of Product, RQM+
Heinrich Martens
Vice President Regulatory Affairs, Fresenius Kabi Deutschland GmbH
Sam Martin
Consultant in BioMedical Technology Regulatory and Clinical Affairs, Director, The Regulatory and Clinical Partnership Ltd
João Martins
Associate Director Regulatory Affairs Strategy, Abbott
Alina Martirosyan
Scientific Manager Toxicology, B. Braun Melsungen AG
Frank Matzek
Vice President Regulatory & Governmental Affairs, BIOTRONIK
Brian McElligott
Partner & Head of AI, Mason Hayes & Curran
Marc Miller
Division President, TransPerfect Medical Device Solutions
Bettina Möbius
Head of Regulatory Affairs - Quality & Regulatory Affairs, Medical Division, Drägerwerk AG & Co. KGaA
Pinalee Nanda
Quality Assurance & Regulatory Affairs Manager, NEC OncoImmunity AS
Nadine Nasr
Regulatory Affairs Manager, Intuitive Surgical
Sean O'Callaghan
Senior Scientific Officer-Certification & Inspection, Medical Devices, National Standards Authority of Ireland (NSAI)
Rolf Oberlin
Special Consultant, Danish Medicines Agency
Laurent Oliviero
Complaint Handling Specialist 4, QuidelOrtho
Jai Pandey
Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
Young Jin Park
Senior RA Project Manager, ECoRA Consulting
Tom Patten
Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
Christian Pellevoisin
Scientific Director, MatTek Life Science
Paolo Pesico
Senior Scientific Director, Medical Devices, Eurofins Medical Device Testing Europe
Paul Piscoi
Policy Officer, D.3 Medical Devices, DG SANTE, European Commission
Özlem Pınar Çetiner
Associate Director, Patient Safety Digital & Devices, AstraZeneca
Helene Quie
CEO, Qmed Consulting A/S
Gina Quiram
Regulatory Affairs Compliance Manager (Biocompatibility and Safety & Performance Standards), Koninklijke Philips N.V.
Abtin Rad
Global Director Functional Safety, Software and Digitization, TÜV SÜD
Valya Ramakrishnan
Regulatory Affairs Compliance Manager, Philips
Alice Ravizza
Founder, InsideAI
Camilla Recke
Director Regulatory Affairs - Companion Diagnostics, Agilent
Renate Reiss
Associate Director Regulator Affairs & Compliance, Institut Straumann AG
Janine Reudt-Demont
Counsel, Niederer Kraft Frey (NKF)
Christina Reufsteck
Biocompatibility Expert, TÜV SÜD Product Service GmbH
Tatsiana Ripich
Head of Regulatory Affairs, Enmodes GmbH
Ricardo Rocha
Senior Associate, PLMJ
Beau Rollins
Director, Quality Services, ConvaTec
Jessica Ruperto
Senior Regulatory Affairs Specialist, Thermo Fisher Scientific
David Rutledge
President & CEO, Global Strategic Solutions
Diana Sanchez-Garcia
Senior Manager Clinical Operations, Philips
Fatima Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
Rina Sant
Principal Clinical Scientist EU MDR, Abbott
Klaus Schichl
Director Clinical Affairs CRM/EP, Biotronik
Phillip Schmidt
Senior Legal Counsel EMEA, Zimmer Biomet
Kazuhisa Senshu
Chief Clinical & Regulatory Affairs Officer, Terumo Japan
Nebojsa Serafimovic
Assessor for Clinical Investigations, Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
James Shearn
Director, Regulatory & Quality Compliance (EMEA), Steris
Aubrey Shick
Sr. Digital Health Advisor, FDA
Nathalie Smyth
Partner, Kennedys
Henk Snyman, MD
Medical Director (EU-MDR),COOK Medical
Courtney Sobieski
Senior Clinical Development Manager, Philips
Josefine Sommer
Partner, Sidley Austin, Belgium
Shaloo Sood
Product Development & RDI Academy, Straumann Group
Sravani Sreeram Nagasai
Technical Program Manager, Google
Andreas Stange
Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
Elisa Stefanini
Partner, Portolano Cavallo
Alexander Stock
Project Manager IVD Medical Device Testing, TÜV SÜD
Maurizio Suppo
Vice President Regulatory Affairs, Qarad – QbD
Agnes Szoboszlai
Regulatory Legal Counsel, Philips
Ashokkumar Thakkar
Head – Clinical Research & Medical Writing, Meril Life Sciences Pvt. Ltd.
Rolf Thermann
Section Manager IVD and Companion Diagnostics Lead, TUV Rhineland
Marcus Torr
PMCF / MDR Lead, Purdie Pascoe
Esther Valk
Senior Regulatory Affairs Manager, Medtronic
Robert van Boxtel
Principal Consultant, Medical Device Project B.V., The Netherlands
Klien van Dam
Director, Quality and Regulatory Affairs EMEA, Avanos Medical
Cécile van der Heijden
Attorney at Law, Axon Lawyers
Jeannette van Loon
CEO, Medical Device Project B.V. (MDProject)
Sandeep Vashist
Senior Global IVD Product Director (Europe), Fapon Biotech Inc
Erik Vollegbret
Partner, Axon Lawyers
Holger Wagner
Head of Regulatory Affairs - Business Unit Hospital Consumables & Accessories, Medical Division, Drägerwerk AG & Co. KGaA
Stephen Weber
Assistant Professor, The Johns Hopkins School of Medicine
Ed Woo
Regulator Affairs Lead, APAC, Philips
Monika Zdzieborska
Senior Managing Associate, Sidley Austin
Trine Østerby
Director, Regulatory Affairs ImmunoAssay, Radiometer
ADVISORY BOARDS:
Fayez Abou Hamad
MD Vigilance Expert Consultant – Pharmacist, Terumo Europe N.V., Belgium
Crystal D’Silva
Manager, Pre-Clinical Toxicology – Global Quality, Baxter
Pat Baird
Senior Regulatory Specialist, Philips
Rich de la Cruz
Principal Consultant Quality and Software, Silver Lake Group, Inc
Christian Pellevoisin
Scientific Director, MatTek Life Science
Nebojsa Serafimovic
Assessor for Clinical Investigations, Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
Ashleigh Batchen
Head of Regulatory Affairs, British In Vitro Diagnostic Association (BIVDA)
Erik Vollegbret
Partner, Axon Lawyers
Ed Woo
Regulator Affairs Lead, APAC, Philips
Melanie Donguy
Head of Regulatory Affairs, Bayer
Beau Rollins
Director, Quality Services, ConvaTec
Henk Snyman, MD
Medical Director (EU-MDR), COOK Medical
Robert van Boxtel
Principal Consultant, Medical Device Project B.V., The Netherlands
Bassil Akra
CEO, Akra Team Gmbh
Andreas Stange
Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
2023 Sponsors
ASSOCIATE SPONSORS:
• Ey
• Knoell
• Rqm
• Veranex
CONFERENCE SPONSORS:
• 3Aware
• Beaufort
• Bsi
• Celegence
• Covington
• Eclevar Medtech
• Elsevier
• Eurofins
• Giotto Compliance
• Mason Hayes&Curan
• Purdie Pascoe
• Qbd Group
• Rimsys