Venue
Sheraton Brussels Airport Hotel
Sheraton Brussels Airport Hotel, Brussels Airport, 1930 Brussel, BE

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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
Details

The summit will be covering EU MDR/IVDR, Clinical Investigations, Post-Market Surveillance, Software/AI, Biocompatibility, Law & Compliance, and Global Market Access.

Speakers

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

Sponsors & Partners

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