Regulatory Competency Framework Knowledge Areas
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Regulatory Competency Framework Knowledge Areas
The presentations below are organized by knowledge areas, as defined by the Regulatory Competency Framework, to help you find sessions aligned with your professional goals.
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Thursday, May 15th
14:30 - 15:30 CESTUsing IMDRF Codes to Analyse Complaints and Connections with Risk ManagementLocation: Silver Hall (level 0)
Moderator & Presenter: – Qserve
Speaker:
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Application of Scientific & Clinical Advances
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Wednesday, May 14th
10:45 - 11:45 CEST“Appropriateness” of Clinical Data – Clinical Evaluations Based on Non-clinical Data OnlyLocation: Copper Hall (level 0)
Speaker: – Escentia GmbH
Speaker: – Hochschule Furtwangen University
Speaker: – BSI
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Application of Scientific& Clinical Advances
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Thursday, May 15th
10:45 - 11:45 CESTPatient-focused Drug Development in EU: From EPAR to Smpc?Location: The Arc (level 3)
Session Leader: – AstraZeneca Rare Diseases, Alexion
Speaker: – Sanofi
Speaker: – European Medicines Agency
Speaker:
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Thursday, May 15th
10:45 - 11:45 CESTRevolutionizing Product Safety and Performance: The Role of Computational Modelling, in Silico Trials, and Global StandardsLocation: Gold Hall (level 0)
Speaker: – British Standards Institution
Speaker: – University of Manchester
Speaker: – Zimmer Biomet
Speaker: – Element Materials Technology | University of Manchester
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Wednesday, May 14th
10:45 - 11:45 CESTEU Variation Regulatory Reform – Creating Innovation in the Life-cycle ManagementLocation: The Arc (level 3)
Speaker: – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: – Kenvue
Speaker: – European Medicines Agency
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Wednesday, May 14th
12:00 - 13:00 CESTAI TestbedsLocation: Gold Hall (level 0)
Moderator: – Philips
Speaker: – TÜV AI.Lab
Speaker: – Kiwa Dare
Speaker: – Kiwa Nederland BV
Speaker: – National Laboratory of Metrology and Testing (LNE)
Software/AI/Cybersecurity
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Thursday, May 15th
12:00 - 13:00 CESTPSUR: Requirements, Experiences and Lessons Learned to Date from Three Stakeholder PerspectivesLocation: Gold Hall (level 0)
Moderator & Presenter: – BSI
Speaker: – Dutch Health and Youth Care Inspectorate (IGJ)
Speaker: – Smith&Nephew
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Classification & Jurisdiction
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Wednesday, May 14th
12:00 - 13:00 CESTMastering IVD Software Classification and Overcoming PMS Regulatory Compliance Challenges at the Interface of the IVDR and the AI ActLocation: Copper Hall (level 0)
Moderator & Presenter: – QUAREGIA GmbH
Speaker: – Constency Healthcare
Speaker: – TÜV SÜD
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Friday, May 16th
11:45 - 12:45 CESTDevice - Drug Borderlines – Challenges in Europe and the USALocation: The Arc (level 3)
Session Leader/Speaker: – NAMSA
Speaker: – Beyond Conception GmbH
Speaker: – European Medicines Agency
Panelist: – TÜV SÜD Product Service GmbH
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Classification & Jursidiction
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Friday, May 16th
11:45 - 12:45 CESTOrphaned Devices - The Needs, Approval Process and Challenges in the EULocation: Gold Hall (level 0)
Moderator & Presenter: – Trinity College, Dublin
Speaker: – BSI
Speaker: – Elekta
Speaker: – Heraeus Medical GmbH
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Thursday, May 15th
08:30 - 09:30 CESTThe Power of Teamwork: Risk Management, Clinical Evaluation and PMS Aka “the Holy Trinity of the MDR” – but What About Claims?!Location: Copper Hall (level 0)
Moderator: – Medical Device Project B.V.
Speaker: – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker: – Escentia GmbH
Speaker: – Smith&Nephew
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Data Management & Analysis
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Tuesday, May 13th
08:30 - 16:00 CESTPreconference Workshop: AI - Your Best Buddy on the Path to Regulatory ComplianceLocation: Studio 201 AB (level 2)
Speaker: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: – CriterionEdge, self-employed
Software/AI/Cybersecurity
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Thursday, May 15th
14:30 - 15:30 CESTBenefits of Standardized Data Models for Digitalization in the Medtech IndustryLocation: Copper Hall (level 0)
Session Leader: – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker: – Siemens Healthineers AG
Speaker: – Siemens Healthineers AG
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Tuesday, May 13th
08:30 - 16:00 CESTPreconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance StudiesLocation: Studio 204 (level 2)
Speaker: – Aignostics
Speaker: – Johnson and Johnson
Speaker: – Qserve Consultancy BV
Speaker: – MDx CRO
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Tuesday, May 13th
08:30 - 16:00 CESTPreconference Workshop: PMS Process- dos and Don'tsLocation: Studio 212 (level 2)
Speaker: – Freelancer
Speaker: – SGS Notified Body, 1639
Speaker: – confinis
Speaker: – confinis
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Wednesday, May 14th
08:30 - 09:30 CESTEU Pharmaceutical Regulatory Reforms – Time to Consider Implementation Challenges and Opportunities?Location: Copper Hall (level 0)
Moderator & Presenter: – Sanofi
Speaker: – Sanofi
Speaker: – European Medicines Agency (EMA)
Speaker: – European Commission
Speaker:
Speaker: – MSD
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Wednesday, May 14th
09:40 - 10:10 CESTSolutions Circle: Mastering PSURs: Streamline Your Process for Faster ApprovalsLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Geistlich Pharma AG
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Wednesday, May 14th
10:15 - 10:45 CESTSolutions Circle: Intended Use: The Foundations of the Medical Device HouseLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Osteogen Ltd
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Wednesday, May 14th
10:15 - 10:45 CESTSolutions Circle: Points to Consider in Deciding on Placebo/active Comparators in Clinical TrialsLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – khhconsulting
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Wednesday, May 14th
10:15 - 10:45 CESTSolutions Circle: Surviving the EHDS: A LifelineLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Axon Lawyers
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Wednesday, May 14th
12:00 - 13:00 CESTMaximizing the Value of Clinical Data for Global Submissions (EU/China)Location: Studio 211 + 212 (level 2)
Session Leader: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – Qserve Group
Speaker: – Notified Body 1639, SGS Belgium
Speaker: – China Med Device, LLC
Speaker: – Siemens Healthineers AG
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Wednesday, May 14th
13:50 - 14:20 CESTSolutions Circle: Cybersecurity in Premarket Submissions: US vs. EU ApproachLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – MES Medical Electronic Systems
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Thursday, May 15th
08:30 - 09:30 CESTEUDAMED Unlocked: Navigating the Current Landscape and Implementation StrategiesLocation: Silver Hall (level 0)
Speaker: – MDSS GmbH
Speaker: – EirMed Ltd
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Thursday, May 15th
10:15 - 10:45 CESTSolutions Circle: Cybersecurity in Premarket Submissions: US vs. EU ApproachLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – MES Medical Electronic Systems
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Thursday, May 15th
10:45 - 11:45 CESTUK Regulatory Landscape: UK MDR Amendments and ImpactLocation: Studio 211 + 212 (level 2)
Moderator: – Compliance Connextions Limited
Speaker: – TUV SUD
Speaker: – BSI
Speaker: – MHRA
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Thursday, May 15th
13:15 - 13:45 CESTSolutions Circle: Intended Use: The Foundations of the Medical Device HouseLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Osteogen Ltd
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Thursday, May 15th
13:15 - 13:45 CESTSolutions Circle: Points to Consider in Deciding on Placebo/active Comparators in Clinical TrialsLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – khhconsulting
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Thursday, May 15th
13:15 - 13:45 CESTSolutions Circle: Surviving the EHDS: A LifelineLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Axon Lawyers
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Thursday, May 15th
13:50 - 14:20 CESTSolutions Circle: Mastering PSURs: Streamline Your Process for Faster ApprovalsLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Geistlich Pharma AG
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Thursday, May 15th
14:30 - 15:30 CESTCombined Studies: Interface Between the Regulations on Clinical Trials of Medicinal Products, Medical Devices and in vitro Diagnostics (Current Situation and Future Regulatory Framework)Location: Gold Hall (level 0)
Moderator: – Benefits Regulatory Consulting
Speaker: – PharmaLex Finland
Speaker: – Aignostics
Speaker: – Danish Medicines Agency (DKMA)
Panelist: – EMA
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Friday, May 16th
10:30 - 11:30 CESTAll in One for Biocompatibility: ISO 10993 Updates, Toxicological Risk Assessment and Post-market DataLocation: Gold Hall (level 0)
Session Leader: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: – Intrinsic Medical Group
Speaker: – Kiwa Cermet Italia SPA
Speaker: – ICON plc
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Friday, May 16th
10:30 - 11:30 CESTChina Drug Regulatory Pathways: 2025 Key Updates and Deep-diveLocation: Studio 211 + 212 (level 2)
Session Leader/Speaker: – Cisema
Speaker: – Cisema (Hong Kong) Limited
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Industry-specific Knowledge
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Wednesday, May 14th
10:45 - 11:45 CESTThe EU AI ActLocation: Gold Hall (level 0)
Speaker: – Ada Health GmbH
Speaker: – BSI
Speaker: – TUV SUD
Speaker: – European Commission
Moderator: – Philips
Software/AI/Cybersecurity
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Wednesday, May 14th
13:50 - 14:20 CESTSolutions Circle: Insight in Motivation: The RA Life Stories That Matter in HealthcareLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – QServe Group
Facilitator: – TÜV SÜD Medical Health Services
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Thursday, May 15th
10:15 - 10:45 CESTSolutions Circle: Insight in Motivation: The RA Life Stories That Matter in HealthcareLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – QServe Group
Facilitator: – TÜV SÜD Medical Health Services
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Friday, May 16th
10:30 - 11:30 CESTSupply Chain Cybersecurity Risk ManagementLocation: Copper Hall (level 0)
Session Leader/Speaker: – FSQ Experts a brand of Wertefest GmbH
Speaker: – University of Waterloo
Speaker: – Philips
Software/AI/Cybersecurity
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Legal & Regulatory Requirements
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Wednesday, May 14th
14:30 - 15:30 CESTAI Sandboxes and AssurancesLocation: Copper Hall (level 0)
Moderator: – Complear
Speaker: – Medicines and Healthcare products Regulatory Agency
Speaker: – Medicines and Healthcare products Regulatory Agency
Speaker:
Speaker:
Panelist: – European Medicines Agency
Software/AI/Cybersecurity
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Thursday, May 15th
08:30 - 09:30 CESTLarge Panel Genomic Profiling and IVDR: Strategies for ManufacturersLocation: Studio 211 + 212 (level 2)
Moderator & Presenter: – Qarad (part of the QbDGroup)
Speaker: – BSI
Speaker: – University of Leuven
Speaker:
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Thursday, May 15th
10:45 - 11:45 CESTPatient-centricity, Value, and Cost-effectiveness of Ai-enabled Medical Devices (AIeMDs)Location: Copper Hall (level 0)
Session Leader/Speaker: – BioSciPons
Speaker: – Dedalus Healthcare
Speaker: – National Institute for Health and Care Excellence
Software/AI/Cybersecurity
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Wednesday, May 14th
14:30 - 15:30 CESTThe Road Ahead: Impact of EU 2024/1860 for MDR and IVDR – Insights from Notified Bodies and IndustryLocation: Silver Hall (level 0)
Speaker: – RQM+
Speaker: – RQM+
Speaker: – BSI
Speaker: – BSI
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Friday, May 16th
10:30 - 11:30 CESTMastering Post-market Surveillance Under IVDR: From PMPF to PSURLocation: Silver Hall (level 0)
Session Leader: – mi-CE consultancy
Speaker: – DEKRA B.V.
Speaker: – TÜV Rheinland
Speaker: – Health and Youth Care Inspectorate (IGJ), Ministry of Health
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Wednesday, May 14th
10:15 - 10:45 CESTSolutions Circle: Structured Dialogue - IVDR - Live ExampleLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – GMED Certification Division
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Thursday, May 15th
12:00 - 13:00 CESTNavigating Pitfalls in Clinical Performance Studies: CRO Insights on Sample Management and Ethical ConsiderationsLocation: Studio 211 + 212 (level 2)
Session Leader/Speaker: – Entourage GmbH
Speaker: – in.vent Diagnostica GmbH
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Thursday, May 15th
13:15 - 13:45 CESTSolutions Circle: Structured Dialogue - IVDR - Live ExampleLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – GMED Certification Division
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Thursday, May 15th
16:45 - 17:45 CESTEMA and FDA Programs to Accelerate Innovation in Treating Unmet Medical NeedsLocation: Studio 214 + 216 (level 2)
Moderator: – Cisema
Speaker: – HMC-regulation
Speaker: – European Medicines Agency
Speaker: – U.S. Food and Drug Administration U.S. Mission to the European Union
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Wednesday, May 14th
09:40 - 10:10 CESTSolutions Circle: Key Considerations for Cdx in Combined Trials Under IVDRLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Precision for Medicine
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Wednesday, May 14th
12:00 - 13:00 CESTChanges in U.S. Politics: Implications for Submissions and Agency CollaborationLocation: Silver Hall (level 0)
Speaker: – Veeva MedTech
Speaker: – dsm-firmenich Biomedical
Speaker: – Edwards Lifesciences Sarl
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Thursday, May 15th
12:00 - 13:00 CESTMastering US FDA Cybersecurity Submissions: Requirements, Deficiencies, and Best PracticesLocation: Copper Hall (level 0)
Session Leader/Speaker: – MedSec
Speaker: – MedSec
Software/AI/Cybersecurity
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Thursday, May 15th
13:50 - 14:20 CESTSolutions Circle: key Considerations for Cdx in Combined Trials Under IVDRLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Precision for Medicine
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Thursday, May 15th
16:45 - 17:45 CESTBringing Innovative Medical Devices to the EU MarketLocation: Silver Hall (level 0)
Moderator: – Edwards Lifesciences
Speaker: – Tuv Sud
Speaker: – INBRAIN Neuroelectronics
Speaker: – European Medicines Agency
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Wednesday, May 14th
13:15 - 13:45 CESTSolutions Circle: Decreasing Complexity, Defining Regulatory and Evaluation Strategy of LLM Based FunctionsLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Philips Healthcare
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Thursday, May 15th
09:40 - 10:10 CESTSolutions Circle: Decreasing Complexity, Defining Regulatory and Evaluation Strategy of LLM Based FunctionsLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Philips Healthcare
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Thursday, May 15th
10:45 - 11:45 CESTNavigating IVDR: Performance Evaluation and Usability for Near-patient and Self-testsLocation: Silver Hall (level 0)
Speaker: – RQM+
Speaker: – QbD
Speaker: – Entourage GmbH
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Thursday, May 15th
12:00 - 13:00 CESTCurrent Developments and Regulatory Trends in Clinical Trial DesignLocation: Studio 214 + 216 (level 2)
Session Leader/Speaker: – Parexel
Speaker: – Phortas GmbH
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Thursday, May 15th
16:45 - 17:45 CESTChina: Key Regulatory & Clinical Updates and Their ImplementationLocation: Studio 211 + 212 (level 2)
Speaker: – China Med Device, LLC
Speaker: – Cisema
Speaker: – Royal Philips
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Thursday, May 15th
16:45 - 17:45 CESTThe Value of Integrating Real-world and Trial Data to Increase Patient BenefitLocation: The Arc (level 3)
Session Leader: – AstraZeneca Rare Diseases, Alexion
Speaker: – Parexel
Speaker: – UCB
Panelist: – European Medicines Agency
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Wednesday, May 14th
13:15 - 13:45 CESTSolutions Circle: ’Growing Pains’: An Evaluation of Evolving Pediatric Study Regulation in the US and EULocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – AstraZeneca
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Wednesday, May 14th
13:50 - 14:20 CESTSolutions Circle: Challenges Related to Data in AI Medical Devices in the European UnionLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – CRITICAL CATALYST
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Thursday, May 15th
09:40 - 10:10 CESTSolutions Circle: "Growing Pains’: An Evaluation of Evolving Pediatric Study Regulation in the US and EULocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – AstraZeneca
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Thursday, May 15th
10:15 - 10:45 CESTSolutions Circle: Challenges Related to Data in AI Medical Devices in the European UnionLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – CRITICAL CATALYST
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Friday, May 16th
10:30 - 11:30 CESTShaping the Future of mRNA Vaccines: A Regulatory PerspectiveLocation: The Arc (level 3)
Moderator: – Cisema
Presenter: – Molgenium
Speaker: – European Medicines Agency
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Regulatory Strategy Development
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Wednesday, May 14th
08:30 - 09:30 CESTAmerica First – Europe Second? Defining Global Market Access Strategies for Start-ups and New DevicesLocation: Studio 211 + 212 (level 2)
Moderator: – Qserve Consultancy BV
Speaker: – Compliance Connextions Limited
Speaker: – Rea Diagnostics
Speaker: – Aiosyn
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Wednesday, May 14th
08:30 - 09:30 CESTMDR Kick-off PanelLocation: Gold Hall (level 0)
Speaker: – QServe Group
Speaker: – TÜV SÜD Medical Health Services
Speaker: – European Commission
Speaker: – TÜV SÜD Medical & Health Services
Speaker: – Ypsomed AG
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Wednesday, May 14th
08:30 - 09:30 CESTRegulatory Considerations for Gene Therapy in Pediatric PatientsLocation: The Arc (level 3)
Moderator: – Cisema
Speaker: – Independent Regulatory Affairs Professional
Speaker: – European Medicines Agency
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Wednesday, May 14th
10:45 - 11:45 CESTAddressing the Complexities of Using in Vitro Diagnostics (IVDs) in Global Clinical TrialsLocation: Studio 214 + 216 (level 2)
Moderator & Presenter: – Qarad (Part of the QbD Group)
Speaker: – Qarad (part of the QbD Group)
Speaker: – GSK
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Wednesday, May 14th
10:45 - 11:45 CESTBiosimilar DevelopmentLocation: Silver Hall (level 0)
Session Leader: – AstraZeneca Rare Diseases, Alexion
Speaker: – Parexel
Speaker: – European Medicines Agency (EMA)
Speaker: – Formycon AG, Martinsried/Planegg, Germany
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Wednesday, May 14th
12:00 - 13:00 CESTNew International: Experiences with the Latest UK Submission RoutesLocation: Studio 214 + 216 (level 2)
Session Leader:
Speaker: – QbD Group
Speaker: – MHRA
Speaker: – Product Life Group
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Wednesday, May 14th
13:15 - 13:45 CESTSolutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on Medical DevicesLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Schrack & Partner
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Wednesday, May 14th
13:15 - 13:45 CESTSolutions Circle: Key Takeaways from 4 Years of Expert Panel Views to Improve Your IVD EvaluationLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
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Wednesday, May 14th
14:30 - 15:30 CESTClinical Data Challenges for Novel and Legacy Medical Devices - Panel Discussion with Clinical Experts from Multiple Notified BodiesLocation: Gold Hall (level 0)
Moderator & Presenter: – AKRA TEAM Inc.
Speaker: – BSI
Speaker: – TÜV SÜD Product Service GmbH
Speaker: – TÜV Rheinland LGA Products GmbH
Speaker: – European Commission - Directorate-General for Health and Food Safety
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Wednesday, May 14th
14:30 - 15:30 CESTEU Green DealLocation: Studio 211 + 212 (level 2)
Speaker: – Axon Lawyers
Speaker: – PRO-LIANCE GLOBAL SOLUTIONS
Speaker:
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Thursday, May 15th
08:30 - 09:30 CESTCybersecurity Across the Medical Device Lifecycle: Addressing Modern and Legacy ProductsLocation: Gold Hall (level 0)
Session Leader/Speaker: – seleon GmbH
Speaker: – Kiwa
Speaker: – QbDGroup
Software/AI/Cybersecurity
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Thursday, May 15th
08:30 - 09:30 CESTReliance Pathways Such as WHO Collaborative Registration Procedure (CRP) to Accelerate the Assessment and Registration of Medicinal ProductsLocation: Studio 214 + 216 (level 2)
Speaker: – Alexion Astra Zeneca Rare Diseases
Speaker: – European Medicines Agency (EMA)
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Thursday, May 15th
09:40 - 10:10 CESTSolutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on Medical DevicesLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
Facilitator: – Schrack & Partner
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Thursday, May 15th
09:40 - 10:10 CESTSolutions Circle: Key Takeaways from 4 Years of Expert Panel Views to Improve Your IVD EvaluationLocation: Exhibit Hall (Grand Hall 1/2 - Level -2)
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Thursday, May 15th
12:00 - 13:00 CESTCMC Strategy / ICH Q9Location: The Arc (level 3)
Speaker: – Kyowa Kirin
Speaker: – European Medicines Agency
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Thursday, May 15th
12:00 - 13:00 CESTNavigating the Intersection of MDR and HTA: Strategic Implications for Medical Device ManufacturersLocation: Silver Hall (level 0)
Session Leader/Speaker: – NAMSA
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Thursday, May 15th
14:30 - 15:30 CESTFrom Confusion to Clarity: Decoding US and European Regulatory Meetings During Development, for Optimal ResultsLocation: The Arc (level 3)
Session Leader: – AstraZeneca Rare Diseases, Alexion
Speaker: – HMC-regulation
Speaker: – European Medicines Agency
Speaker: – FAGG - Federal agency for medicines and health products (Belgium)
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Thursday, May 15th
14:30 - 15:30 CESTFrom Wellness to Clinical Care: Regulating at the Intersection of Medical and Non-Medical Devices in Hybrid Digital Health/AI SuitesLocation: Studio 214 + 216 (level 2)
Session Leader: – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: – Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Speaker: – DNS - French Ministry of Health
Software/AI/Cybersecurity
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Thursday, May 15th
14:30 - 15:30 CESTNavigating Mergers and Acquisitions: Transitioning Products from IVDD/MD to IVDR/MDR ComplianceLocation: Studio 211 + 212 (level 2)
Speaker: – Reliance Quality & Regulatory Consulting
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Thursday, May 15th
16:45 - 17:45 CESTCritical IVDR Milestones & EU Reference Laboratories… a Testing TimeLocation: Copper Hall (level 0)
Moderator: – GSK
Speaker: – TÜV SÜD
Speaker: – TÜV Rheinland
Speaker: – Abbott Core Diagnostics
Speaker: – Dutch Health and Youthcare Inspectorate
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Friday, May 16th
11:45 - 12:45 CESTAdaptive and Evolving Ai-enabled Medical DevicesLocation: Silver Hall (level 0)
Moderator & Presenter: – Philips
Speaker: – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: – King & Spalding LLP
Software/AI/Cybersecurity
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Friday, May 16th
11:45 - 12:45 CESTInvolving European Reference Laboratories in the Conformity Assessment of Class D Ivd's: Operational Update After 6 MonthsLocation: Copper Hall (level 0)
Moderator: – Qarad (Part of the QbD Group)
Speaker: – BSI
Speaker: – RISE
Speaker: – Paul-Ehrlich-Institut
Speaker: – Tuv Rheinland
Panelist: – European Commission
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Review Process Management
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Friday, May 16th
11:45 - 12:45 CESTUsing Artificial Intelligence to Support Regulatory Processes and Decision-MakingLocation: Studio 211 + 212 (level 2)
Session Leader/Speaker: – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: – European Medicines Agency
Speaker: – regenold GmbH
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Wednesday, May 14th
10:45 - 11:45 CESTGlobal Perspectives on Usability and Human Factors Studies in Regulatory Submissions: Navigating the US, EU, and China LandscapeLocation: Studio 211 + 212 (level 2)
Session Leader/Speaker: – confinis ag
Speaker: – China Med Device, LLC
Speaker:
Speaker: – CSL Behring
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Thursday, May 15th
10:45 - 11:45 CESTDigital Transformation in Regulatory Tools and Dossier SubmissionLocation: Studio 214 + 216 (level 2)
Moderator & Presenter: – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: – Accumulus Synergy
Speaker: – European Medicines Agency
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Thursday, May 15th
16:45 - 17:45 CESTEvolving with Technology: Navigating Current Regulatory Challenges and Future Directions in IoMT CybersecurityLocation: Gold Hall (level 0)
Moderator & Presenter: – Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Speaker: – seleon GmbH
Speaker: – Ostrich Consulting LLC
Speaker: – TÜV SÜD
Software/AI/Cybersecurity