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Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: AI - Your Best Buddy on the Path to Regulatory Compliance
Location: Studio 201 AB (level 2)
Speaker: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: Sarai Pahla, Bachelors Degree in Medicine and Surgery, Masters Degree in Regulatory Affairs – CriterionEdge, self-employed
Software/AI/Cybersecurity
Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: Clinical Evaluation - Optimizing Clinical Data and State-of-the-art Searches for MDR Compliance
Location: Studio 211 (level 2)
Speaker: Christiane Reinwald, PhD (Dr. rer. nat.) – be-on-Quality GmbH
Speaker: Mette Stoedter, PhD (Dr rer medic) (she/her/hers) – be-on-Quality GmbH
Speaker: David John Mandley, PhD (he/him/his) – NAMSA
Medical Devices
Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: EU Pharmaceutical Regulatory Reform
Location: Studio 202 (level 2)
Workshop Leader: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Speaker: Yves Jacob (he/him/his) – Sanofi
Speaker: Alberto Ganan, PhD – European Medicines Agency
Speaker: Lilia Luchianov – European Commission
Speaker: Nikos Dedes
Pharmaceuticals
Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies
Location: Studio 204 (level 2)
Speaker: Natalie Batty, MPH – Aignostics
Speaker: Marina Belonogova, PhD (she/her/hers) – Johnson and Johnson
Speaker: Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy BV
Speaker: Carlos Galamba – MDx CRO
IVDs
Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: IVDR Technical Documentation
Location: Studio 206 (level 2)
Workshop Leader: Francesca Bevilacqua, PhD (she/her/hers) – TÜV SÜD Italy
Speaker: Catherine Holzmann, PhD – GMED Certification Division
Speaker: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Speaker: Marco Caproni (he/him/his) – TUV SUD
Speaker: Guillaume Berger – GMED
IVDs
Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: PMS Process- dos and Don'ts
Location: Studio 212 (level 2)
Speaker: Vaso Basinou, PhD (she/her/hers) – Freelancer
Speaker: Ivan Stoyanov, Dr. – SGS Notified Body, 1639
Speaker: Andrea Biasiucci, PhD – confinis
Speaker: Claudio Alberti, PhD (he/him/his) – confinis
Medical Devices