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Wednesday, May 10, 2023
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Sander, Kirsten
Labquality Oy
Sponsored Presentation: Impact of CER on PMCF and Clinical Investigation
Location: Pearl 2
Kirsten Sander
Favorite
Saunders, Richard
QuidelOrtho
Conformity Assessment of Class D Devices: What is the Current Status?
Location: Pearl 2
Richard Saunders
Favorite
Scheiblauer, Heinrich
Paul-Ehrlich-Institut
Conformity Assessment of Class D Devices: What is the Current Status?
Location: Pearl 2
Heinrich Scheiblauer
Favorite
Scheib, Stefan
Roche Diagnostics GmbH
Conformity Assessment of Class D Devices: What is the Current Status?
Location: Pearl 2
Stefan Scheib
Favorite
Schmidt, Beate
Benefits Regulatory Consulting
MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and Industry
Location: Pearl 2
Beate Schmidt
Favorite
Schmidt, Kristiane
Qserve Group
Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
Location: Carmine & Charcoal
Kristiane Schmidt
Favorite
Schmitt, Siegfried
Parexel
European Expedited Approval Pathways in a Global Context
Location: Carmine & Charcoal
Siegfried Schmitt
Favorite
Schouten, Jet
NRC (newspaper)
Opening Plenary Session: Leveraging our joint clinical data: the new frontier - a debate on our dreams!
Location: Pearl 1 + 2 + 3
Jet Schouten
Favorite
Shah, Rohan
BD
Expert Advisory Panel - What Have we Learned?
Location: Pearl 1
Rohan Shah
Favorite
Shiryaev, Alexey
DNV Product Assurance AS
Clinical assessment: how to minimize the questions from your Notified Body
Location: Pearl 2
Alexey Shiryaev
Favorite
Smirthwaite, Amie
RQM+
Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified Bodies
Location: Pearl 1
Amie Smirthwaite
Favorite
Sponsored Presentations: The Impact of AI on MedTech: Current and Future Applications
Location: Pearl 3
Amie Smirthwaite
Favorite
Smith, Eileen
PPD, part of Thermo Fisher Scientific
Be ready for EU CTR: Strategy, Systems and Lessons Learned
Location: Saffron (1st fl)
Eileen Smith
Favorite
Smith, Meredith
EVIDERA
Risk Management Workshop
Location: Carmine (1st fl)
Meredith Smith
Favorite
Spencer, Sue
Qserve group
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
Location: Pearl 3
Sue Spencer
Favorite
Sponsored Presentations: FDA first, CE later. Clinical and regulatory strategy trends
Location: Pearl 2
Sue Spencer
Favorite
Spirig, Patrik
Konapharma
Due Diligence: Critical Importance of Regulatory & Quality to Support Company or Product Acquisitions
Location: Pearl 3
Patrik Spirig
Favorite
Spony, Julie
European Patients' Forum
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
Location: Pearl 1
Julie Spony
Favorite
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )
Location: Pearl 1
Julie Spony
Favorite
Stange, Andreas
TUV SUD JAPAN LTD
IVDR Transition: Quo Vadis? – the current reality
Location: Carmine & Charcoal
Andreas Stange
Favorite
MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?
Location: Pearl 2
Andreas Stange
Favorite
Stanislawski, Pierre
Ennov
Sponsored Presentations: Global regulatory platform vs integrations: Challenges for data consistency
Location: Coral & Cyan
Pierre Stanislawski
Favorite
Steffen, Beat
confinis ag
AI/machine learning based-medical software: case studies on model development and regulatory compliance
Location: Pearl 1
Beat Steffen
Favorite
Stock, Alexander
TÜV SÜD Product Service GmbH
Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing Approaches
Location: Carmine & Charcoal
Alexander Stock
Favorite
Stockman, Kate
Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?
Location: Pearl 1
Kate Stockman
Favorite
Sullivan, Michelle
Boston Scientific
Standards & Compliance: Updates on ‘Sustainable’ Medical Devices
Location: Pearl 2
Michelle Sullivan
Favorite
Suppo, Maurizio
Qarad
Conformity Assessment of Class D Devices: What is the Current Status?
Location: Pearl 2
Maurizio Suppo
Favorite
Szaller, Laetitia
AM-Pharma
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
Location: Pearl 1
Laetitia Szaller
Favorite
Szoboszlai, Agnes
Philips Medical Systems Nederland B.V.
Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
Location: Pearl 3
Agnes Szoboszlai
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