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The RAPS Regulatory Competency Framework is a one-of-a-kind tool to help you map your experience to align with your learning goals. Use this section of the navigation to browse Convergence sessions by framework levels, domains, and knowledge areas to further enhance your learning goals.
For full framework details, domain, and knowledge area definitions, visit https://www.raps.org/resources/regulatory-competency-framework.
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Application of Scientific and Clinical Advances
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Tuesday, May 7th
13:45 – 14:45 CESTRandomized Clinical Trials vs. Validation Cohort Studies of AI/ML-Based SaMDs: What Are the Differences and Guidelines for Appraisal of the Clinical Evidence?Location: B 05 + B 06
Presenter: – BioSciPons
Presenter: – Dedalus
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Data Management and Analysis
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Tuesday, May 7th
13:45 – 14:45 CESTThe Future of Standardization in Medtech and Its Impact on Your Regulatory ComplianceLocation: B 09
Session Leader/Speaker: – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
Presenter: – DIN Media (formerly Beuth Verlag)
Presenter: – DIN e.V.
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Wednesday, May 8th
10:25 – 11:25 CESTCollaboration Works: Risk Management – Clinical Evaluation – PMS/PMCF UnitedLocation: B 05 + B 06
Moderator: – Medical Device Project B.V.
Presenter: – Escentia GmbH
Presenter: – Smith+Nephew
Presenter: – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
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Monday, May 6th
08:30 – 16:00 CESTPre-Conference Workshop: IVDR Technical Documentation Location: B 09
Workshop Leader: – TUV Sud GmbH
Presenter: – GMED
Presenter: – BSI
Presenter: – NBCG-Med - Notified Body Coordination Group
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Tuesday, May 7th
08:30 – 09:30 CESTBiocompatibility: Substances of Concern – Have You Checked? GSPR 10.4 a Practical GuideLocation: A 03 + A 04
Moderator: – RAPS Germany
Presenter: – NAMSA
Presenter: – Fresenius Kabi Deutschland GmbH
Presenter: – TÜV SÜD Medical & Health Services
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Wednesday, May 8th
14:00 – 15:00 CESTData at the Core: Understanding Your Company's Critical Yet Underutilized ToolLocation: A 03 + A 04
Moderator: – SANOFI
Presenter: – Asher Biotherapeutics, Inc.
Presenter: – Bayer Plc
Presenter: – F. Hoffmann-La Roche Ltd
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Tuesday, May 7th
09:50 – 10:50 CESTNew EU Pharma LegislationLocation: A 05 + A 06
Presenter: – Sanofi
Presenter: – European Patients' Forum
Presenter: – European Medicines Agency
Presenter: – EFPIA
Presenter: – European Commission
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Tuesday, May 7th
11:30 – 12:00 CESTUK Market: PMS and Vigilance Requirements for IVDsLocation: B 05 + B 06
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Tuesday, May 7th
11:30 – 12:30 CESTCareer Development: Forging a Career Path in the Age of TechnologyLocation: A 03 + A 04
Moderator & Presenter: – Complear
Presenter: – Northeastern University
Presenter: – QARALOGIC
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Tuesday, May 7th
11:30 – 12:30 CESTThe MDR and The AI Act: A Match Made in Heaven or The Odd Couple? Location: C 01
Moderator: – Mason Hayes & Curran LLP
Presenter: – Philips
Presenter: – Axon Lawyers
Presenter: – Else Kröner Fresenius Center for Digital Health
Presenter: – TÜV Verband
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Tuesday, May 7th
11:30 – 12:30 CESTThe MDR Hurdle for Startups and Innovation – And Strategies To Overcome ItLocation: B 09
Moderator: – Founder of Waypoint Consulting
Presenter: – RoX Health GmbH
Presenter: – self employed
Presenter: – Qserve
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Tuesday, May 7th
13:45 – 14:45 CESTUnveiling Insights: Navigating the Public Disclosure of Clinical Trials in an Evolving IndustryLocation: B 07 + B 08
Presenter: – IQVIA
Presenter: – Certara
Presenter: – Danish Medicines Agency
Panelist: – European Medicines Agency
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Tuesday, May 7th
15:05 – 16:05 CESTPost-Market requirements: Keeping PSUR and SSCP up to DateLocation: B 09
Moderator: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – W. L Gore & Associates
Presenter: – MED-EL
Presenter: – Smith+Nephew
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Tuesday, May 7th
15:05 – 16:05 CESTSecuring AI Solutions in Medtech ProductsLocation: A 05 + A 06
Presenter: – Royal Philips
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Tuesday, May 7th
16:45 – 17:45 CESTRegulators and Industry Perspective on Use of Artificial Intelligence in the Drug Development LifecycleLocation: B 07 + B 08
Session Leader: – Vita Green Group
Session Leader/Speaker: – Accumulus Synergy
Presenter:
Presenter: – European Medicines Agency
Presenter: – F.Hoffmann-La Roche, Ltd.
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Wednesday, May 8th
10:25 – 11:25 CESTCTA with Devices: State of Play for Non-CE Marked Diagnostic Tests in European Clinical TrialsLocation: A 05 + A 06
Presenter: – Qarad
Presenter: – Entourage GmbH
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Wednesday, May 8th
10:25 – 11:25 CESTThe Paradigm Shift in the EU Market Approval of Devices and IVDs – a Hot Potato?!Location: C 01
Moderator: – QServe Group B.V.
Presenter: – TÜV SÜD Medical Health Service
Presenter: – Boston Scientific
Presenter: – QServe Group
Presenter: – Axon Lawyers
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Wednesday, May 8th
11:45 – 12:45 CESTMaintaining Compliance: IVDR Post-Certification ActivitiesLocation: B 09
Presenter: – BSI
Presenter: – Immunotech SAS (Beckman Coulter)
Presenter: – Qarad
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Wednesday, May 8th
11:45 – 12:45 CESTPatient-Centric Endpoints and Use of Digital Health TechnologiesLocation: A 03 + A 04
Moderator: – Benefits Regulatory Consulting
Presenter: – khhconsulting
Presenter: – Teva Pharmaceuticals
Presenter: – Hyman, Phelps & McNamara, P.C.
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Wednesday, May 8th
14:00 – 15:00 CESTIMDRF Coding: Complaints, Vigilance, Trend Analysis, and the Benefits of Codifying Your Post Market Surveillance SystemLocation: B 05 + B 06
Moderator: – Medical Device Project B.V.
Presenter: – DLRC
Presenter: – Dutch Health and Youth Care Inspectorate
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Tuesday, May 7th
09:50 – 10:50 CESTRegulatory Leadership: Digitization and Digital Health – There is NO Turning Back!Location: B 09
Session Leader/Speaker: – Boston Scientific
Presenter: – IBEC
Presenter: – Veeva Systems
Presenter: – Boston Scientific
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Industry-specific Knowledge
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Tuesday, May 7th
11:30 – 12:30 CESTKey Trends Impacting HTA and Regulatory InterfaceLocation: B 07 + B 08
Moderator & Presenter: – Sanofi
Presenter: – Sanofi
Presenter: – National Institute for Health and Care Excellence
Panelist: – European Medicines Agency
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Tuesday, May 7th
15:05 – 16:05 CESTUse of Real World Evidence for Regulatory Making for Medical Devices and Diagnostics in EU: A Practical GuideLocation: C 01
Session Leader/Speaker: – Notified Body (BSI)
Presenter: – Aetion
Panelist: – Trinity College Dublin
Panelist: – Boston Scientific
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Legal and Regulatory Requirements
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Wednesday, May 8th
11:45 – 12:45 CESTData Security and Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health DataLocation: B 05 + B 06
Presenter: – Axon Lawyers
Presenter: – Elekta
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Wednesday, May 8th
11:45 – 12:45 CESTSupply Chain/ShortageLocation: A 05 + A 06
Presenter: – CAI
Presenter: – Parexel International India Safety Services Private Limited
Presenter: – Parexel
Presenter: – EMA
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Tuesday, May 7th
09:50 – 10:50 CESTClinical Performance Studies Under IVDRLocation: A 03 + A 04
Presenter: – RQM+
Presenter: – Precision for Medicine
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Tuesday, May 7th
13:45 – 14:45 CESTIVDR Class D Devices – Latest Updates and ExperienceLocation: A 03 + A 04
Presenter: – TÜV SÜD
Presenter: – BSI
Presenter: – Roche Diagnostics GmbH
Presenter: – BSI
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Wednesday, May 8th
14:00 – 15:00 CESTCybersecurity: Integrating Medical Device Cybersecurity in the Quality Management SystemLocation: B 07 + B 08
Session Leader/Speaker: – MEDIcept, Inc.
Presenter: – RAPS BoD
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Quality Management and Continuous Improvement
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Monday, May 6th
08:30 – 16:00 CESTPre-Conference Workshop: What Does it Take From CE to MDSAP?Location: A 03
Workshop Leader: – nexialist
Presenter: – nexialist
Presenter: – DQS Medizinprodukte GmbH
Presenter: – TÜV NORD CERT
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Monday, May 6th
08:30 – 16:00 CESTPre-Conference Workshop: EUDAMEDLocation: B 07 + B 08
Workshop Leader: – BSI
Presenter: – Schrack & Partner
Presenter: – BSI
Presenter: – Johnson & Johnson MedTech
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Tuesday, May 7th
09:50 – 10:50 CESTEmerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions Location: B 05 + B 06
Moderator:
Presenter: – Accumulus Synergy
Presenter: – EXTEDO GmbH
Presenter: – Certara
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Monday, May 6th
08:30 – 16:00 CESTPre-Conference Workshop: Global Regulatory CMC Approaches for Biologicals: From Strategy to ExecutionLocation: A 04
Workshop Leader: – Argenx
Presenter: – BioNTech SE
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Tuesday, May 7th
09:50 – 10:50 CESTClinical Evaluation: Unifying Clinical Evaluation Requirements: Exploring ISO 18969 and the "New MEDDEV 2.7/1"Location: B 07 + B 08
Moderator & Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – MD-CLINICALS SA
Presenter: – BSI
Presenter: – European Commission - Directorate-General for Health and Food Safety
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Tuesday, May 7th
12:00 – 12:30 CESTUsability and Human Factors Studies – Considerations During Pre-Market Submission, Similarities and Differences Between the US and EuropeLocation: B 05 + B 06
Presenter: – Regulatory Affairs and IP Director
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Tuesday, May 7th
16:45 – 17:45 CESTImportance of New Active Substance Status for Biologics, and CMC Strategies for Development of C&G TherapiesLocation: A 05 + A 06
Session Leader/Speaker: – Fortrea
Presenter: – Sanofi
Panelist:
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Wednesday, May 8th
11:45 – 12:45 CESTClinical Evaluation: Complexity in Simplicity: Regulatory Challenges for Standard of Care Medical DevicesLocation: C 01
Session Leader/Speaker: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – SLG Prüf- und Zertifizierungs GmbH
Presenter: – QUESTALPHA GmbH & Co. KG
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Wednesday, May 8th
11:45 – 12:45 CESTEnvironmental Regulation: How EU Green Deal and Other Environmental Regulations Affect Medical Devices and IVDsLocation: B 07 + B 08
Session Leader/Speaker: – Axon Lawyers
Presenter: – MedTech Europe
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Wednesday, May 8th
15:40 – 16:40 CESTAn overview of AI, Software and Cybersecurity regulations in AsiaLocation: B 09
Presenter: – FSQ Experts
Presenter: – Merative
Presenter: – Compliance and risks
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Regulatory Strategy Development
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Tuesday, May 7th
08:30 – 09:30 CESTPatient Access: Regulatory, HTA, and Patient Perspectives on an Orphan Drug – Case Study of Erythropoietic ProtoporphyriaLocation: B 07 + B 08
Moderator: – Benefits Regulatory Consulting
Presenter: – MBM Future Health, AMNOG Advisory Services
Presenter: – International Porphyria Patient Network (IPPN)
Presenter: – khhconsulting
Panelist: – European Medicines Agency
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Tuesday, May 7th
08:30 – 09:30 CESTThe IVDR Clock is Ticking... But Should There be Alarm?Location: B 05 + B 06
Presenter: – MCRA
Panelist: – BSI
Panelist: – MedTech Europe
Panelist: – TUV Sud GmbH
Panelist: – Federal Ministry of Health Germany
Panelist: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
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Tuesday, May 7th
09:50 – 10:50 CESTArtificial Intelligence in the Context of the IVDR – How to Keep the Revolution Under ControlLocation: C 01
Session Leader/Speaker: – TÜV SÜD
Presenter: – Entourage GmbH
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Tuesday, May 7th
11:30 – 12:30 CESTUK MDR: Current State of Play and Future PerspectivesLocation: A 05 + A 06
Moderator: – Edwards Lifesciences
Presenter: – TUV SUD
Presenter: – BSI
Presenter:
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Tuesday, May 7th
13:45 – 14:45 CESTMeeting EMA and FDA: Formal and Informal Pathways in Search of AlignmentLocation: A 05 + A 06
Presenter: – Phortas GmbH
Presenter: – European Medicines Agency
Presenter: – Arriello
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Tuesday, May 7th
15:05 – 16:05 CESTCDx or Not CDx, That is The Question – The Impact of The IVD Regulation on IVDs Used in Pharmaceutical Clinical TrialsLocation: B 07 + B 08
Presenter: – Aignostics
Presenter: – J&J
Presenter:
Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
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Tuesday, May 7th
15:05 – 16:05 CESTFrom China to WHO: Strategies and Updates to Accelerate China and WHO Drug Approvals and Master FilesLocation: A 03 + A 04
Session Leader/Speaker: – Cisema
Presenter: – Accestra Consulting Company
Presenter: – EXTEDO GmbH
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Tuesday, May 7th
16:45 – 17:45 CESTDon’t Get Orphaned: How To Be Novel in the IVDR EnvironmentLocation: A 03 + A 04
Session Leader/Speaker: – BSI
Presenter: – NAMSA
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Tuesday, May 7th
16:45 – 17:45 CESTNavigating the future: Embracing AI and ChatGPT in Regulatory Affairs and Quality Management for Pharma and MedTech Professionals AlikeLocation: B 09
Session Leader/Speaker: – G&L Healthcare Advisors
Presenter: – China Med Device, LLC
Presenter: – Johner Institut GmbH
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Tuesday, May 7th
16:45 – 17:45 CESTPre-Clinical Evaluations and Clinical Investigations. Strategizing Towards Efficiency and New Approaches Including in Silico MethodsLocation: C 01
Presenter: – Qserve
Presenter: – Fraunhofer IMTE
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Wednesday, May 8th
10:25 – 11:25 CESTTackling Regulatory Challenges in a Global Marketplace: Developing a Robust Performance Evaluation Strategy for IVDsLocation: B 07 + B 08
Session Leader/Speaker: – Qserve Group
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Wednesday, May 8th
12:45 – 13:15 CESTSESSION IS FULL Circle: Essentials of EU Regulatory Intelligence; Overview of Key Aspects of Regulatory IntelligenceLocation: B 95
Solutions Circle - Ticket Required
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Wednesday, May 8th
14:00 – 15:00 CESTExperience Gain From Implementing Article 5(5) of the IVDR in a Network of European LaboratoriesLocation: B 09
Session Leader/Speaker: – Unilabs
Presenter: – Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften
Presenter: – Axon Lawyers
Presenter: – Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE
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Wednesday, May 8th
14:00 – 15:00 CESTInternational Regulatory Frameworks to Accelerate Orphan Drug RegistrationsLocation: A 05 + A 06
Session Leader/Speaker: – Alexion Astra Zeneca Rare Diseases
Presenter: – European Medicines Agency
Presenter: – Foundation of Borys the Hero
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Wednesday, May 8th
15:40 – 16:40 CESTBlood, Sweat, and Tears – Biologics and Their ChallengesLocation: A 05 + A 06
Moderator: – Parexel
Presenter: – ENTOURAGE GmbH
Presenter: – Pharmaceutcial
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Wednesday, May 8th
15:40 – 16:40 CESTIVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?Location: C 01
Moderator: – BSI
Presenter: – mi-CE consultancy
Presenter: – BSI
Presenter: – NBCG-Med - Notified Body Coordination Group
Presenter: – TUV Sud GmbH
Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
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Wednesday, May 8th
15:40 – 16:40 CESTRegulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a Case StudyLocation: A 03 + A 04
Presenter: – UCB
Presenter: – UCB
Presenter: – Gilead
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Wednesday, May 8th
15:40 – 16:40 CESTStructured Dialogue: Innovative Pathways in Europe and UK: A Legal, Manufacturer’s, and Notified Bodies PerspectiveLocation: B 05 + B 06
Presenter: – Smith+Nephew
Presenter: – Bristows LLP
Presenter: – Notified Body (BSI)
Panelist: – European Medicines Agency
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Wednesday, May 8th
15:40 – 16:40 CESTOrphan Devices: How to Obtain Orphan or Pediatric Medical Device ApprovalLocation: B 07 + B 08
Moderator:
Presenter: – Elekta
Presenter: – Olympus Surgical Technologies Europe
Panelist: – European Medicines Agency
