Preconference Workshops

Preconference Workshops
All Preconference workshops require a separate registration fee and are not included in main conference pricing. Learn more:  https://www.raps.org/europe-2023/register

Preconference Workshops

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Thursday, May 11th
09:00 – 10:00 CEST
IVDR Transition: Quo Vadis? – the current reality
Location: Carmine & Charcoal
Moderator & Presenter: Andreas Stange – TUV SUD JAPAN LTD
Moderator & Presenter: Erica Conway, PhD – MCRA
Presenter: Tom Patten – NSAI
Presenter: Niels Bojunga, Dr – Molecular Health GmbH
Presenter: Kees Maquelin – Abbott Diabetes Care
Presenter: Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVDDomain: Product Development & RegistrationKnowledge Area: Submission Management
Supported by
Thursday, May 11th
09:00 – 10:00 CEST
MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?
Location: Pearl 2
Moderator: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
Presenter: Flora Giorgio – European Commission
Presenter: Royth Philippp von Hahn, PhD – TUV SUD Product Services
Presenter: Graeme Turnbridge – BSI
Presenter: Alexandre Jauniaux – Federal Agency of Medicines and Health products
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
Supported by
Thursday, May 11th
10:30 – 11:30 CEST
Traceability of devices; the administrative burden or a smart set-up for legal manufacturers?
Location: Pearl 3
Moderator: Susana de Azevedo Wäsch – Ypsomed
Presenter: Daniëlle Motta, MSc. – Qserve Group
Presenter: Lionel Tussau – atrify
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
Supported By
Thursday, May 11th
11:45 – 12:45 CEST
Clinical assessment: how to minimize the questions from your Notified Body
Location: Pearl 2
Moderator: Giovanni Di Rienzo – Qserve Group
Presenter: Sheila Walsh – BSI
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
Supported By
Thursday, May 11th
13:45 – 14:45 CEST
AI/machine learning based-medical software: case studies on model development and regulatory compliance
Location: Pearl 1
Moderator: Leo Louis, RAC, PMP – Philips
Presenter: abhineet johri, MCA – Siemens Healthineers
Presenter: Martina Coscia, PhD – confinis AG
Presenter: Beat Steffen, MSc, FRAPS – confinis ag
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
Supported By
Thursday, May 11th
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
Location: Pearl 2
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Presenter: Stephan Affolter – Ypsomed AG
Presenter: Christiana Hofmann, PHD – anteris medical GmbH
Presenter: Christelle Bouygues, PharmD – EMA
Presenter: Theresa Jeary, BSc (Hons), MSc – BSI Group
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
Supported By
Thursday, May 11th
16:45 – 17:45 CEST
Conformity Assessment of Class D Devices: What is the Current Status?
Location: Pearl 2
Moderator: Maurizio Suppo, Dr. – Qarad
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Presenter: Catherine Holzmann – GMED Certification Division
Presenter: Olga TKACHENKO, PhD – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
Presenter: Elisabeth PhD Dequeker, PhD – University of Leuven
Presenter: Richard J. Saunders, FIBMS – QuidelOrtho
Presenter: Stefan Scheib, PhD – Roche Diagnostics GmbH
Presenter: Heinrich Scheiblauer, Dr – Paul-Ehrlich-Institut
IVDDomain: Product Development & RegistrationKnowledge Area: Process & Procedures
Supported By
Thursday, May 11th
16:45 – 17:45 CEST
Expert Advisory Panel - What Have we Learned?
Location: Pearl 1
Presenter: Richard Holborow – BSI
Presenter: Silvy Da Rocha Dias – European Medicines Agency
Presenter: Rohan Shah, BS – BD
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: General
Supported By
Friday, May 12th
10:45 – 11:45 CEST
Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified Bodies
Location: Pearl 1
Moderator: Amie Smirthwaite, BEng, PhD – RQM+
Presenter: Nancy J. Morrison, RAC – RQM+
Presenter: Abtin Rad, Dr. – TÜV SÜD Product Services
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
Supported By
Friday, May 12th
14:00 – 15:00 CEST
Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing Approaches
Location: Carmine & Charcoal
Moderator & Presenter: Alexander Stock, PhD – TÜV SÜD Product Service GmbH
IVDDomain: Product Development & RegistrationKnowledge Area: Data Management & Analysis
Supported By
Friday, May 12th
14:00 – 15:00 CEST
Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?
Location: Pearl 1
Moderator: Kate Stockman
Moderator: Rüdiger Faust, PhD – UCB
Presenter: Solange Corriol-Rohou, MD – AstraZeneca
Presenter: Marie Teil, MD – UCB Pharma
Presenter: Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
Supported By
Friday, May 12th
15:30 – 16:30 CEST
Cybersecurity: Compliantly Securing our Healthcare Future
Location: Pearl 3
Moderator & Presenter: Michelle Jump, RAC – MedSec LLC
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
Supported By
Friday, May 12th
15:30 – 16:30 CEST
European Expedited Approval Pathways in a Global Context
Location: Carmine & Charcoal
Moderator: Siegfried Schmitt, CSci CChem FRSC – Parexel
Presenter: Yingying Liu – CSL Behring AG
Presenter: Thomas Larsson, MSc, BSc – European Medicines Agency
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
Supported By