- Thursday, May 11, 2023
08:00 – 09:00 CEST
Live LInkedin Profile Feedback Session
08:00 – 09:00 CEST
Live LInkedin Profile Feedback Session
Elena Kyria – Elemed ### 1083155###Moderator###CEO & Founder###Elemed###Moderator: – Elemed
### 08:00 – 18:00 CEST
Registration Open
08:00 – 18:00 CEST
Registration Open
08:30 – 17:45 CEST
Poster Viewing & Voting
08:30 – 17:45 CEST
Poster Viewing & Voting
09:00 – 10:00 CEST
Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
09:00 – 10:00 CEST
Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health DataPresenter: – Axon Lawyers
Presenter: – ?
Presenter: – Philips Medical Systems Nederland B.V.
Presenter: – Elekta nucletron
Medical Devices
Domain: Ethics
Knowledge Area: Legal & Regulatory Requirements
Erik R. Vollebregt, n/a – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### @@@ Cécile Van der Heijden – ? ### 1827162###Presenter###Senior associate###?###Presenter: – ?
### @@@ Agnes Szoboszlai – Philips Medical Systems Nederland B.V. ### 1827163###Presenter###Senior Legal Counsel###Philips Medical Systems Nederland B.V.###Presenter: – Philips Medical Systems Nederland B.V.
### @@@ Leo Hovestadt – Elekta nucletron ### 535504###Presenter###International Regulatory Affairs and Quality Assurance Director###Elekta nucletron###Presenter: – Elekta nucletron
### 09:00 – 10:00 CEST
IVDR Transition: Quo Vadis? – the current reality
09:00 – 10:00 CEST
IVDR Transition: Quo Vadis? – the current realityModerator & Presenter: – TUV SUD JAPAN LTD
Moderator & Presenter: – MCRA
Presenter: – NSAI
Presenter: – Molecular Health GmbH
Presenter: – Abbott Diabetes Care
Presenter: – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVD
Domain: Product Development & Registration
Knowledge Area: Submission Management
Andreas Stange – TUV SUD JAPAN LTD ### 1187582###Moderator & Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD JAPAN LTD###Moderator & Presenter: – TUV SUD JAPAN LTD
### @@@ Erica Conway, PhD (she/her/hers) – MCRA ### 1828301###Moderator & Presenter###Vice President, IVD Regulatory Affairs - Europe###MCRA###Moderator & Presenter: – MCRA
### she/her/hers @@@ Tom Patten, MSc – NSAI ### 1141749###Presenter###Certification and Inspection Officer###NSAI###Presenter: – NSAI
### @@@ Niels Bojunga – Molecular Health GmbH ### 1919734###Presenter###SVP of Quality Management###Molecular Health GmbH###Presenter: – Molecular Health GmbH
### @@@ Kees Maquelin – Abbott Diabetes Care ### 1919788###Presenter###Regulatory Affairs Manager Europe###Abbott Diabetes Care###Presenter: – Abbott Diabetes Care
### @@@ Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health ### 1919791###Presenter###Coordinating Specialist###Health and Youth Care Inspectorate (IGJ), Ministry of Health###Presenter: – Health and Youth Care Inspectorate (IGJ), Ministry of Health
### 09:00 – 10:00 CEST
MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?
09:00 – 10:00 CEST
MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?Moderator & Presenter: – TÜV SÜD Medical Health Service
Presenter: – QServe
Presenter: – European Commission
Presenter: – TUV SUD Product Services
Presenter: – BSI
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 574720###Moderator & Presenter###Global Director Regulatory Strategy###TÜV SÜD Medical Health Service###Moderator & Presenter: – TÜV SÜD Medical Health Service
### @@@ Gert W. Bos, FRAPS, MSc, PhD, FRAPS – QServe ### 535440###Presenter###CSO###QServe###Presenter: – QServe
### @@@ Flora Giorgio – European Commission ### 1930380###Presenter######European Commission###Presenter: – European Commission
### @@@ Royth Philippp von Hahn, PhD – TUV SUD Product Services ### 1027488###Presenter###Senior Vice President of Medical Health Services (global)###TUV SUD Product Services###Presenter: – TUV SUD Product Services
### @@@ Graeme Turnbridge – BSI ### 1939249###Presenter###Senior Vice President Global Regulatory and Quality, Medical Devices###BSI###Presenter: – BSI
### 09:00 – 10:00 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
09:00 – 10:00 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)Presenter: – Pfizer
Presenter: – Sanofi
Presenter:
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Nick Sykes – Pfizer ### 1827166###Presenter###Senior Director, Global Regulatory Affairs###Pfizer###Presenter: – Pfizer
### @@@ Rebecca Lumsden, PhD – Sanofi ### 1827170###Presenter###Head of Regulatory Science & Policy EU/AMEE###Sanofi###Presenter: – Sanofi
### @@@ Francesca Day ### 1922319###Presenter#########Presenter:
### 10:00 – 10:30 CEST
Chapter/LNG Meet and Greets
10:00 – 10:30 CEST
Chapter/LNG Meet and Greets
Location: Foyer 1
10:00 – 10:30 CEST
Presenters at Posters
10:00 – 10:30 CEST
Presenters at Posters
10:00 – 10:30 CEST
Refreshment Break in Exhibit Area
10:00 – 10:30 CEST
Refreshment Break in Exhibit Area
10:30 – 11:30 CEST
Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER
10:30 – 11:30 CEST
Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CERModerator: – QServe
Presenter: – Qserve Group
Presenter: – GymnaUniphy
Presenter: – Qserve Group BV
Medical Devices
Domain: Scientific & Health Concepts
Knowledge Area: Application of Scientific & Clinical Advances
Gert W. Bos, FRAPS, MSc, PhD, FRAPS – QServe ### 535440###Moderator###CSO###QServe###Moderator: – QServe
### @@@ María Cámara Torres, PhD – Qserve Group ### 1827168###Presenter###Consultant - Medical Writer###Qserve Group###Presenter: – Qserve Group
### @@@ Lise Op de Beeck (she/her/hers) – GymnaUniphy ### 1942154###Presenter###Clinical manager###GymnaUniphy###Presenter: – GymnaUniphy
### she/her/hers @@@ Jorn van Binsbergen, MSc (he/him/his) – Qserve Group BV ### 1944258###Presenter###Consultant / Clinical writer###Qserve Group BV###Presenter: – Qserve Group BV
### he/him/his10:30 – 11:30 CEST
IMDRF- latest developments and future perspectives
10:30 – 11:30 CEST
IMDRF- latest developments and future perspectives Moderator & Presenter: – Abbott
IVDR
Domain: Regulatory Frameworks & Strategy
Knowledge Area: General
Philippe M. Auclair, Mr – Abbott ### 535445###Moderator & Presenter###Senior Director RA strategy###Abbott###Moderator & Presenter: – Abbott
### 10:30 – 11:30 CEST
Supply Chain
10:30 – 11:30 CEST
Supply ChainPresenter: – Qserve Group B.V.
Presenter:
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Documentation
Danielle Motta, n/a – Qserve Group B.V. ### 1649497###Presenter###Head of Global Registrations/Consultant###Qserve Group B.V.###Presenter: – Qserve Group B.V.
### @@@ Daniel Muggli ### 1883925###Presenter#########Presenter:
### 10:30 – 11:30 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 2)
10:30 – 11:30 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )Presenter: – Pfizer
Presenter: – Sanofi
Presenter:
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Nick Sykes – Pfizer ### 1827166###Presenter###Senior Director, Global Regulatory Affairs###Pfizer###Presenter: – Pfizer
### @@@ Rebecca Lumsden, PhD – Sanofi ### 1827170###Presenter###Head of Regulatory Science & Policy EU/AMEE###Sanofi###Presenter: – Sanofi
### @@@ Francesca Day ### 1922319###Presenter#########Presenter:
### 11:45 – 12:45 CEST
Clinical assessment: how to minimize the questions from your Notified Body
11:45 – 12:45 CEST
Clinical assessment: how to minimize the questions from your Notified BodyModerator: – Qserve
Presenter: – BSI
Presenter: – DNV
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Documentation
Giovanni Di Rienzo – Qserve ### 907127###Moderator###Principal Consultant###Qserve###Moderator: – Qserve
### @@@ Sheila Walsh, n/a – BSI ### 1828321###Presenter###Clinical Regulatory Lead###BSI###Presenter: – BSI
### @@@ Alexey Shiryaev, MD, PhD – DNV ### 1645653###Presenter###Head of Clinical and Regulatory Affairs###DNV###Presenter: – DNV
### 11:45 – 12:45 CEST
Recent developments in UK regulations for IVDs: implications for EU manufacturers.
11:45 – 12:45 CEST
Recent developments in UK regulations for IVDs: implications for EU manufacturers.Moderator: – NAMSA
Presenter: – Abbott
Presenter: – Namsa
IVD
Domain: Scientific & Health Concepts
Knowledge Area: General
Alex Laan, Dipl.-Ing. – NAMSA ### 1141533###Moderator###Principal Regulatory Consultant, IVD###NAMSA###Moderator: – NAMSA
### @@@ Philippe M. Auclair, Mr – Abbott ### 535445###Presenter###Senior Director RA strategy###Abbott###Presenter: – Abbott
### @@@ Christèle East, PhD (she/her/hers) – Namsa ### 1828312###Presenter###Senior Regulatory Consultant, IVD###Namsa###Presenter: – Namsa
### she/her/hers11:45 – 12:45 CEST
Use of The Innovative Licensing and Access Pathway (ILAP) for an AAV Gene Therapy
11:45 – 12:45 CEST
Use of The Innovative Licensing and Access Pathway (ILAP) for an AAV Gene TherapyPresenter: – Neurogene
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Paulette Robinson, Ph.D, RAC – Neurogene ### 1827164###Presenter###Director of Regulatory Affairs###Neurogene###Presenter: – Neurogene
### @@@ Caroline Pothet, PharmD (she/her/hers) – European Medicines Agency ### 1942126###Presenter###Head of Advanced Therapies - Human Medicines Division###European Medicines Agency###Presenter: – European Medicines Agency
### she/her/hers11:45 – 12:45 CEST
Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI Icebergs
11:45 – 12:45 CEST
Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI IcebergsPresenter: – BioSciPons
Presenter: – Philips
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Catarina Carrão – BioSciPons ### 1828303###Presenter###CEO###BioSciPons###Presenter: – BioSciPons
### @@@ Koen Cobbaert (he/him/his) – Philips ### 943170###Presenter###Senior Manager - Quality, Standards & Regulations###Philips###Presenter: – Philips
### he/him/his12:45 – 13:45 CEST
Lunch, Exhibits, Posters
12:45 – 13:45 CEST
Lunch, Exhibits, Posters
13:00 – 13:30 CEST
Sponsored Presentation
13:00 – 13:30 CEST
Sponsored Presentations
13:45 – 14:45 CEST
AI/machine learning based-medical software: case studies on model development and regulatory compliance
13:45 – 14:45 CEST
AI/machine learning based-medical software: case studies on model development and regulatory complianceModerator: – Philips
Presenter: – Siemens Healthineers
Presenter: – confinis AG
Presenter: – confinis ag
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Market Strategy
Leo Louis, RAC, PMP – Philips ### 1312131###Moderator###Sr. Regulatory Affairs Manager###Philips###Moderator: – Philips
### @@@ abhineet johri, MCA – Siemens Healthineers ### 1828304###Presenter###Regulatory Affairs Professional ###Siemens Healthineers###Presenter: – Siemens Healthineers
### @@@ Martina Coscia, PhD – confinis AG ### 1828322###Presenter###Head of Innovative Technologies and Clinical Affairs###confinis AG###Presenter: – confinis AG
### @@@ Beat Steffen, MSc, FRAPS – confinis ag ### 716683###Presenter###Founder, Chairman of the Board of Directors & CEO###confinis ag###Presenter: – confinis ag
### 13:45 – 14:45 CEST
CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR Applies
13:45 – 14:45 CEST
CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR AppliesModerator & Presenter: – Qserve Group Ltd
Presenter: – Guardant Health
Presenter: – AstraZeneca
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Sue Spencer – Qserve Group Ltd ### 1187575###Moderator & Presenter###IVD Lead/ Principal Consultant###Qserve Group Ltd###Moderator & Presenter: – Qserve Group Ltd
### @@@ Ed Godber, n/a – Guardant Health ### 1828298###Presenter###Vice President Strategic Partnerships###Guardant Health###Presenter: – Guardant Health
### @@@ Patrick Fivey (he/him/his) – AstraZeneca ### 1828300###Presenter###Director of Precision Medicine Policy###AstraZeneca###Presenter: – AstraZeneca
### he/him/his13:45 – 14:45 CEST
Designing Training for an Evolving Regulatory Environment
13:45 – 14:45 CEST
Designing Training for an Evolving Regulatory EnvironmentPresenter: – Medtronic
Presenter: – Medtronic
Regulatory Business
Domain: Post Approval/Post Market
Knowledge Area: Change Management
Sandra Wheeler, MA Technical Communication – Medtronic ### 1827171###Presenter###Principal Training & Development Specialist###Medtronic###Presenter: – Medtronic
### @@@ Pamela Campo, MS Regulatory Science – Medtronic ### 1827172###Presenter###Principal Regulatory Affairs Specialist###Medtronic###Presenter: – Medtronic
### 13:45 – 14:45 CEST
MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and Industry
13:45 – 14:45 CEST
MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and IndustryPresenter: – Ypsomed AG
Presenter: – anteris medical GmbH
Presenter: – EMA
Presenter: – BSI Group
Pharmaceuticals
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Stephan Affolter – Ypsomed AG ### 907117###Presenter###Regulatory + Quality Intelligence Manager###Ypsomed AG###Presenter: – Ypsomed AG
### @@@ Christiana Hofmann, PHD (she/her/hers) – anteris medical GmbH ### 1864620###Presenter###Executive Consultant & Business Development###anteris medical GmbH###Presenter: – anteris medical GmbH
### she/her/hers @@@ Christelle Bouygues – EMA ### 1318405###Presenter###Regulatory Affairs Officer###EMA###Presenter: – EMA
### @@@ Theresa Jeary, BSc (Hons), MSc – BSI Group ### 535537###Presenter###Principal Technical Specialist ###BSI Group###Presenter: – BSI Group
### 15:00 – 16:00 CEST
IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation
15:00 – 16:00 CEST
IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation Presenter: – Prof
Presenter: – Pharmalex Nordics
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: General
Elisabeth Dequeker, n/a – Prof ### 1828308###Presenter###Full Professor, Head of Quality Assurance and Regulatory Affairs Officer###Prof###Presenter: – Prof
### @@@ Tiina Riihimäki, PhD (she/her/hers) – Pharmalex Nordics ### 1930216###Presenter###Director /
Head of Medical Devices and IVDs, Nordics###Pharmalex Nordics###Presenter: – Pharmalex Nordics
### she/her/hers15:00 – 16:00 CEST
Medical device regulation in international perspective: EU IMDRF Chair in 2023
15:00 – 16:00 CEST
Medical Device Regulation in International Perspective: EU IMDRF Chair in 2023Presenter: – TÜV SÜD Medical Health Service
Medical Devices
Domain: Business Acumen
Knowledge Area: Industry-specific Knowledge
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 574720###Presenter###Global Director Regulatory Strategy###TÜV SÜD Medical Health Service###Presenter: – TÜV SÜD Medical Health Service
### 15:00 – 16:00 CEST
Regulatory Policies and Guidelines – Are These Enabling Timely Development of Orphan Medicines Globally?
15:00 – 16:00 CEST
Regulatory policies and guidelines – are these enabling timely development of Orphan medicines globally? Presenter: – CIRS
Presenter: – Ipsen Innovation
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Magdalena Bujar, BSc, MSc, PhD – CIRS ### 1523611###Presenter###Senior Manager###CIRS###Presenter: – CIRS
### @@@ Martine Zimmermann, PharmD – Ipsen Innovation ### 1452236###Presenter######Ipsen Innovation###Presenter: – Ipsen Innovation
### @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Presenter###Head of Orphan Drugs###European Medicines Agency###Presenter: – European Medicines Agency
### 15:00 – 16:00 CEST
Responsibilities and Liabilities in an Interconnected World
15:00 – 16:00 CEST
Responsibilities and Liabilities in an Interconnected WorldModerator: – Ypsomed
Presenter: – Philips
Presenter: – Axon Lawyers
Presenter:
Medical Devices
Susana de Azevedo Wäsch, n/a – Ypsomed ### 1141752###Moderator###VP Quality Management & Regulatory Affairs & Medical Affairs###Ypsomed###Moderator: – Ypsomed
### @@@ Koen Cobbaert (he/him/his) – Philips ### 943170###Presenter###Senior Manager - Quality, Standards & Regulations###Philips###Presenter: – Philips
### he/him/his @@@ Erik R. Vollebregt, n/a – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### @@@ Andrei Ninu ### 1864621###Presenter#########Presenter:
### 16:00 – 16:45 CEST
Presenters at Posters
16:00 – 16:45 CEST
Coffee Break - Exhibits, Presenters at Posters
16:00 – 16:45 CEST
Refreshment Break in Exhibit Area
16:00 – 16:45 CEST
Refreshment Break in Exhibit Area
16:05 – 16:35 CEST
Sponsored Presentation
16:05 – 16:35 CEST
Sponsored Presentations
16:45 – 17:45 CEST
Conformity Assessment of Class D Devices: What is the Current Status?
16:45 – 17:45 CEST
Conformity Assessment of Class D Devices: What is the Current Status?Moderator: – Qarad
Presenter: – TÜV SÜD GmbH
Presenter: – GMED Certification Division
Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
Presenter: – University of Leuven
Presenter: – QuidelOrtho
Presenter: – Roche Diagnostics GmbH
Presenter: – Paul-Ehrlich-Institut
IVD
Domain: Product Development & Registration
Knowledge Area: Process & Procedures
Maurizio Suppo, Dr. – Qarad ### 1000097###Moderator###Principal Consultant###Qarad###Moderator: – Qarad
### @@@ Marta Carnielli, PharmD – TÜV SÜD GmbH ### 1187616###Presenter###Head of Certification IVD###TÜV SÜD GmbH###Presenter: – TÜV SÜD GmbH
### @@@ Holzmann Catherine – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: – GMED Certification Division
### @@@ Olga TKACHENKO – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6 ### 1828315###Presenter###Scientific Policy Officer###European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6###Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
### @@@ Elisabeth PhD Dequeker, PhD – University of Leuven ### 1254350###Presenter###Head of Quality Assurance and Regulatory Affairs Officer for Medical Diagnostics###University of Leuven###Presenter: – University of Leuven
### @@@ Richard J. Saunders, FIBMS – QuidelOrtho ### 1828316###Presenter###Technical Director, Regulatory Affairs###QuidelOrtho###Presenter: – QuidelOrtho
### @@@ Stefan Scheib, PhD (he/him/his) – Roche Diagnostics GmbH ### 1836161###Presenter###Global Head of Regulatory Affairs, CoreLab###Roche Diagnostics GmbH###Presenter: – Roche Diagnostics GmbH
### he/him/his @@@ Heinrich Scheiblauer, Dr – Paul-Ehrlich-Institut ### 1891462###Presenter###Head of the Testing Laboratory for in vitro diagnotic medical devices###Paul-Ehrlich-Institut###Presenter: – Paul-Ehrlich-Institut
### 16:45 – 17:45 CEST
Expert Advisory Panel - What Have we Learned?
16:45 – 17:45 CEST
Expert Advisory Panel - What Have we Learned?Presenter: – BSI
Presenter:
Presenter:
Medical Devices
Domain: Product Development & Registration
Knowledge Area: General
Richard Holborow (he/him/his) – BSI ### 1523592###Presenter###Global Head of Clinical Compliance###BSI###Presenter: – BSI
### he/him/his @@@ Silvy Da Rocha Dias ### 1922318###Presenter#########Presenter:
### @@@ Rohan Shah ### 1941778###Presenter#########Presenter:
### 16:45 – 17:45 CEST
Global Regulatory CMC Strategies and Challenges
16:45 – 17:45 CEST
Global Regulatory CMC Strategies and ChallengesModerator & Presenter: – Parexel Consulting
Presenter: – argenx
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Business Acumen
Knowledge Area: Industry-specific Knowledge
Michael Craig, BSc Pharm, M.P.S.I – Parexel Consulting ### 535462###Moderator & Presenter###Vice President (Technical)###Parexel Consulting###Moderator & Presenter: – Parexel Consulting
### @@@ Neha Parashar, PMP – argenx ### 1827161###Presenter###Principal Scientist / Associate Director###argenx###Presenter: – argenx
### @@@ Veronika Jekerle, PhD – European Medicines Agency ### 1940209###Presenter###Head of Pharmaceutical Quality###European Medicines Agency###Presenter: – European Medicines Agency
### 16:45 – 17:45 CEST
Regulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.
16:45 – 17:45 CEST
Regulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.Presenter: – Olympus Surgical Technologies Europe
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Market Strategy
Stephanie Huebner, MSc, PhD – Olympus Surgical Technologies Europe ### 1827158###Presenter###Manager Third Party (OEM) Therapeutic Solutions Division, Regulatory Affairs###Olympus Surgical Technologies Europe###Presenter: – Olympus Surgical Technologies Europe
### 18:30 – 21:00 CEST
Networking Dinner – Kanarie Club
18:30 – 21:00 CEST
Networking Dinner – Kanarie Club
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