The RAPS Regulatory Competency Framework
- Home
- The RAPS Regulatory Competency Framework
The RAPS Regulatory Competency Framework is a one-of-a-kind tool to help you map your experience to align with your learning goals. Euro Convergence sessions are labeled with a domain and corresponding knowledge area. Use this page to search by domain or knowledge area to select conference programs that are aligned to your learning goals.
For full framework details, domain, and knowledge area definitions, visit https://www.raps.org/resources/regulatory-competency-framework.
-
-
Thursday, May 11th
15:00 – 16:00 CESTMedical Device Regulation in International Perspective: EU IMDRF Chair in 2023Location: Pearl 3
Moderator: – TÜV SÜD Medical Health Services
Presenter: – Qserve Group
Presenter: – European Commission
Presenter: – Dutch Health and Youth Care Inspectorate
Medical DevicesDomain: Business AcumenKnowledge Area: Industry-specific Knowledge
-
Thursday, May 11th
16:45 – 17:45 CESTEU Regulatory CMC Strategies and ChallengesLocation: Carmine & Charcoal
Moderator & Presenter: – Parexel
Presenter: – argenx
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Business AcumenKnowledge Area: Industry-specific Knowledge
-
Friday, May 12th
12:00 – 13:00 CESTWill Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?Location: Carmine & Charcoal
Moderator & Presenter: – Sanofi
Presenter: – Medicines Evaluation Board
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Business AcumenKnowledge Area: Project Management
-
Friday, May 12th
14:00 – 15:00 CESTDue Diligence: Critical Importance of Regulatory & Quality to Support Company or Product AcquisitionsLocation: Pearl 3
Moderator & Presenter: – Ypsomed
Presenter: – Konapharma
Regulatory BusinessDomain: Business AcumenKnowledge Area: General
-
-
Thursday, May 11th
09:00 – 10:00 CESTData Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health DataLocation: Pearl 3
Moderator & Presenter: – Axon Lawyers
Presenter: – Axon Lawyers
Presenter: – Philips Medical Systems Nederland B.V.
Presenter: – Elekta
Medical DevicesDomain: EthicsKnowledge Area: Legal & Regulatory Requirements
-
Domain: Post Approval/Post Market
-
Thursday, May 11th
13:45 – 14:45 CESTDesigning Training for an Evolving Regulatory EnvironmentLocation: Carmine & Charcoal
Presenter: – Medtronic
Presenter: – Medtronic
Regulatory BusinessDomain: Post Approval/Post MarketKnowledge Area: Change Management
-
Friday, May 12th
10:45 – 11:45 CESTDevice Lifetime and Lifecycle ManagementLocation: Pearl 3
Moderator: – Qserve Group
Presenter: – Oriel STAT A MATRIX
Presenter: – TÜV SÜD Product Service GmbH
Medical DevicesDomain: Post Approval/Post MarketKnowledge Area: Recordkeeping, Monitoring
-
Friday, May 12th
10:45 – 11:45 CESTMeeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting systemLocation: Carmine & Charcoal
Moderator: – BSI
Presenter: – Qserve Group
Presenter: – Constency Healthcare
Presenter: – TUV Sud GmbH
IVDDomain: Post Approval/Post MarketKnowledge Area: General
-
Domain: Product Development & Registration
-
Thursday, May 11th
09:00 – 10:00 CESTIVDR Transition: Quo Vadis? – the current realityLocation: Carmine & Charcoal
Moderator & Presenter: – TUV SUD JAPAN LTD
Moderator & Presenter: – MCRA
Presenter: – NSAI
Presenter: – Molecular Health GmbH
Presenter: – Abbott Diabetes Care
Presenter: – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVDDomain: Product Development & RegistrationKnowledge Area: Submission Management
-
Thursday, May 11th
09:00 – 10:00 CESTMDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?Location: Pearl 2
Moderator: – TÜV SÜD Medical Health Services
Moderator: – Qserve Group
Presenter: – European Commission
Presenter: – TUV SUD Product Services
Presenter: – BSI
Presenter: – Federal Agency of Medicines and Health products
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Thursday, May 11th
10:30 – 11:30 CESTTraceability of devices; the administrative burden or a smart set-up for legal manufacturers?Location: Pearl 3
Moderator: – Ypsomed
Presenter: – Qserve Group
Presenter: – atrify
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
-
Thursday, May 11th
11:45 – 12:45 CESTClinical assessment: how to minimize the questions from your Notified BodyLocation: Pearl 2
Moderator: – Qserve Group
Presenter: – BSI
Presenter: – DNV Product Assurance AS
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
-
Thursday, May 11th
13:45 – 14:45 CESTAI/machine learning based-medical software: case studies on model development and regulatory complianceLocation: Pearl 1
Moderator: – Philips
Presenter: – Siemens Healthineers
Presenter: – confinis AG
Presenter: – confinis ag
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
-
Thursday, May 11th
13:45 – 14:45 CESTMDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and IndustryLocation: Pearl 2
Moderator: – Benefits Regulatory Consulting
Presenter: – Ypsomed AG
Presenter: – anteris medical GmbH
Presenter: – EMA
Presenter: – BSI Group
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Thursday, May 11th
16:45 – 17:45 CESTConformity Assessment of Class D Devices: What is the Current Status?Location: Pearl 2
Moderator: – Qarad
Presenter: – TUV Sud GmbH
Presenter: – GMED Certification Division
Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
Presenter: – University of Leuven
Presenter: – QuidelOrtho
Presenter: – Roche Diagnostics GmbH
Presenter: – Paul-Ehrlich-Institut
IVDDomain: Product Development & RegistrationKnowledge Area: Process & Procedures
-
Thursday, May 11th
16:45 – 17:45 CESTExpert Advisory Panel - What Have we Learned?Location: Pearl 1
Presenter: – BSI
Presenter: – European Medicines Agency
Presenter: – BD
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: General
-
Friday, May 12th
10:45 – 11:45 CESTMedical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified BodiesLocation: Pearl 1
Moderator: – RQM+
Presenter: – RQM+
Presenter: – TÜV SÜD Product Services
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Friday, May 12th
14:00 – 15:00 CESTSoftware and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing ApproachesLocation: Carmine & Charcoal
Moderator & Presenter: – TÜV SÜD Product Service GmbH
IVDDomain: Product Development & RegistrationKnowledge Area: Data Management & Analysis
-
Friday, May 12th
14:00 – 15:00 CESTStrategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?Location: Pearl 1
Moderator:
Moderator: – UCB
Presenter: – AstraZeneca
Presenter: – UCB Pharma
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Friday, May 12th
15:30 – 16:30 CESTCybersecurity: Compliantly Securing our Healthcare FutureLocation: Pearl 3
Moderator & Presenter: – MedSec LLC
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
-
Friday, May 12th
15:30 – 16:30 CESTEuropean Expedited Approval Pathways in a Global ContextLocation: Carmine & Charcoal
Moderator: – Parexel
Presenter: – CSL Behring AG
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Domain: Regulatory Frameworks & Strategy
-
Thursday, May 11th
09:00 – 10:00 CESTWill the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)Location: Pearl 1
Moderator & Presenter: – Sanofi
Presenter: – European Medicines Agency
Presenter: – European Patients' Forum
Presenter: – AM-Pharma
Presenter: – European Commission
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Thursday, May 11th
10:30 – 11:30 CESTIMDRF- latest developments and future perspectives Location: Carmine & Charcoal
Moderator & Presenter: – Abbott
IVDRDomain: Regulatory Frameworks & StrategyKnowledge Area: General
-
Thursday, May 11th
10:30 – 11:30 CESTWill the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )Location: Pearl 1
Moderator & Presenter: – Sanofi
Presenter: – European Medicines Agency
Presenter: – European Patients' Forum
Presenter: – European Commission
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Thursday, May 11th
11:45 – 12:45 CESTMaking full use of early access and regultatory tools available to ATMPsLocation: Carmine & Charcoal
Moderator: – Sartorius Stedim Biotech GmbH
Presenter: – Neurogene
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
-
Thursday, May 11th
11:45 – 12:45 CESTUsing TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI IcebergsLocation: Pearl 1
Moderator & Presenter: – BioSciPons
Moderator & Presenter: – Philips
Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
-
Thursday, May 11th
13:45 – 14:45 CESTCDx 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 AppliesLocation: Pearl 3
Moderator & Presenter: – Qserve group
Presenter: – Guardant Health
Presenter: – AstraZeneca
IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Thursday, May 11th
15:00 – 16:00 CESTIVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation Location: Carmine & Charcoal
Moderator & Presenter: – Prof
Presenter: – Pharmalex Nordics
IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: General
-
Thursday, May 11th
15:00 – 16:00 CESTRegulatory policies and guidelines – are these enabling timely development of Orphan medicines globally? Location: Pearl 1
Moderator & Presenter: – CIRS
Presenter: – Ipsen Innovation
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
-
Thursday, May 11th
16:45 – 17:45 CESTRegulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.Location: Pearl 3
Presenter: – Olympus Surgical Technologies Europe
Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
-
Friday, May 12th
10:45 – 11:45 CESTEMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future DirectionsLocation: Pearl 2
Moderator & Presenter: – European Medicines Agency
Presenter: – Janssen Pharmaceutical Companies of Johnson & Johnson
Presenter: – Bristol-Myers Squibb
Presenter:
Presenter: – Austrian Medicines Agency, AGES MEA
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
-
Friday, May 12th
12:00 – 13:00 CESTReal World Evidence...What Could Possibly go Wrong? A Clinician's PerspectiveLocation: Pearl 2
Moderator: – Qserve Group
Presenter: – W.L. Gore & Associates
Presenter: – BSI
Presenter: – DePuy Synthes (J&J)
Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Data Management & Analysis
-
Friday, May 12th
12:00 – 13:00 CESTResearch Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?Location: Pearl 1
Moderator & Presenter: – Integrated DNA Technologies, Inc., a Danaher Company
Presenter: – SOPHiA GENETICS
Presenter: – BSI
IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Friday, May 12th
15:30 – 16:30 CESTClosing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since PublicationLocation: Pearl 1
Moderator: – Medical Device Project B.V.
Presenter: – BSI Group
Presenter: – TÜV SÜD Product Service GmbH
Presenter: – DEKRA Certification BV
Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Data Management & Analysis
-
Friday, May 12th
15:30 – 16:30 CESTMDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?Location: Pearl 2
Moderator: – TÜV SÜD Medical Health Service
Moderator: – mi-CE consultancy
Presenter: – TUV SUD JAPAN LTD
Presenter: – TUV Sud GmbH
Presenter: – BSI Group
Presenter: – DEKRA Certification B.V.
Presenter: – NSAI
IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
-
Domain: Scientific & Health Concepts
-
Thursday, May 11th
10:30 – 11:30 CESTClinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CERLocation: Pearl 2
Moderator: – Qserve Group
Presenter: – Qserve Group
Presenter: – GymnaUniphy
Presenter: – Qserve Group
Medical DevicesDomain: Scientific & Health ConceptsKnowledge Area: Application of Scientific & Clinical Advances
-
Thursday, May 11th
11:45 – 12:45 CESTRecent developments in UK regulations for IVDs: implications for EU manufacturers.Location: Pearl 3
Moderator: – BSI
Presenter: – Abbott
Presenter: – Namsa
IVDDomain: Scientific & Health ConceptsKnowledge Area: General
-
Friday, May 12th
14:00 – 15:00 CESTStandards & Compliance: Updates on ‘Sustainable’ Medical DevicesLocation: Pearl 2
Moderator: – Philips
Presenter: – BSI
Presenter: – Boston Scientific
Medical DevicesDomain: Scientific & Health ConceptsKnowledge Area: Healthcare Leadership
-
Knowledge Area: Change Management
-
Thursday, May 11th
13:45 – 14:45 CESTDesigning Training for an Evolving Regulatory EnvironmentLocation: Carmine & Charcoal
Presenter: – Medtronic
Presenter: – Medtronic
Regulatory BusinessDomain: Post Approval/Post MarketKnowledge Area: Change Management
-
Knowledge Area: Documentation
-
Thursday, May 11th
10:30 – 11:30 CESTTraceability of devices; the administrative burden or a smart set-up for legal manufacturers?Location: Pearl 3
Moderator: – Ypsomed
Presenter: – Qserve Group
Presenter: – atrify
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
-
Thursday, May 11th
11:45 – 12:45 CESTClinical assessment: how to minimize the questions from your Notified BodyLocation: Pearl 2
Moderator: – Qserve Group
Presenter: – BSI
Presenter: – DNV Product Assurance AS
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation
-
-
Thursday, May 11th
10:30 – 11:30 CESTIMDRF- latest developments and future perspectives Location: Carmine & Charcoal
Moderator & Presenter: – Abbott
IVDRDomain: Regulatory Frameworks & StrategyKnowledge Area: General
-
Thursday, May 11th
11:45 – 12:45 CESTRecent developments in UK regulations for IVDs: implications for EU manufacturers.Location: Pearl 3
Moderator: – BSI
Presenter: – Abbott
Presenter: – Namsa
IVDDomain: Scientific & Health ConceptsKnowledge Area: General
-
Thursday, May 11th
15:00 – 16:00 CESTIVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation Location: Carmine & Charcoal
Moderator & Presenter: – Prof
Presenter: – Pharmalex Nordics
IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: General
-
Thursday, May 11th
16:45 – 17:45 CESTExpert Advisory Panel - What Have we Learned?Location: Pearl 1
Presenter: – BSI
Presenter: – European Medicines Agency
Presenter: – BD
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: General
-
Friday, May 12th
10:45 – 11:45 CESTMeeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting systemLocation: Carmine & Charcoal
Moderator: – BSI
Presenter: – Qserve Group
Presenter: – Constency Healthcare
Presenter: – TUV Sud GmbH
IVDDomain: Post Approval/Post MarketKnowledge Area: General
-
Friday, May 12th
14:00 – 15:00 CESTDue Diligence: Critical Importance of Regulatory & Quality to Support Company or Product AcquisitionsLocation: Pearl 3
Moderator & Presenter: – Ypsomed
Presenter: – Konapharma
Regulatory BusinessDomain: Business AcumenKnowledge Area: General
-
Knowledge Area: Healthcare Leadership
-
Friday, May 12th
14:00 – 15:00 CESTStandards & Compliance: Updates on ‘Sustainable’ Medical DevicesLocation: Pearl 2
Moderator: – Philips
Presenter: – BSI
Presenter: – Boston Scientific
Medical DevicesDomain: Scientific & Health ConceptsKnowledge Area: Healthcare Leadership
-
Knowledge Area: Industry-specific Knowledge
-
Thursday, May 11th
15:00 – 16:00 CESTMedical Device Regulation in International Perspective: EU IMDRF Chair in 2023Location: Pearl 3
Moderator: – TÜV SÜD Medical Health Services
Presenter: – Qserve Group
Presenter: – European Commission
Presenter: – Dutch Health and Youth Care Inspectorate
Medical DevicesDomain: Business AcumenKnowledge Area: Industry-specific Knowledge
-
Thursday, May 11th
16:45 – 17:45 CESTEU Regulatory CMC Strategies and ChallengesLocation: Carmine & Charcoal
Moderator & Presenter: – Parexel
Presenter: – argenx
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Business AcumenKnowledge Area: Industry-specific Knowledge
-
Knowledge Area: Market Strategy
-
Thursday, May 11th
13:45 – 14:45 CESTAI/machine learning based-medical software: case studies on model development and regulatory complianceLocation: Pearl 1
Moderator: – Philips
Presenter: – Siemens Healthineers
Presenter: – confinis AG
Presenter: – confinis ag
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
-
Thursday, May 11th
16:45 – 17:45 CESTRegulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.Location: Pearl 3
Presenter: – Olympus Surgical Technologies Europe
Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
-
Friday, May 12th
10:45 – 11:45 CESTEMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future DirectionsLocation: Pearl 2
Moderator & Presenter: – European Medicines Agency
Presenter: – Janssen Pharmaceutical Companies of Johnson & Johnson
Presenter: – Bristol-Myers Squibb
Presenter:
Presenter: – Austrian Medicines Agency, AGES MEA
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
-
Friday, May 12th
15:30 – 16:30 CESTCybersecurity: Compliantly Securing our Healthcare FutureLocation: Pearl 3
Moderator & Presenter: – MedSec LLC
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy
-
Knowledge Area: Project Management
-
Friday, May 12th
12:00 – 13:00 CESTWill Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?Location: Carmine & Charcoal
Moderator & Presenter: – Sanofi
Presenter: – Medicines Evaluation Board
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Business AcumenKnowledge Area: Project Management
-
Knowledge Area: Recordkeeping, Monitoring
-
Friday, May 12th
10:45 – 11:45 CESTDevice Lifetime and Lifecycle ManagementLocation: Pearl 3
Moderator: – Qserve Group
Presenter: – Oriel STAT A MATRIX
Presenter: – TÜV SÜD Product Service GmbH
Medical DevicesDomain: Post Approval/Post MarketKnowledge Area: Recordkeeping, Monitoring
-
Knowledge Area: Regulatory Guidance
-
Thursday, May 11th
09:00 – 10:00 CESTMDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?Location: Pearl 2
Moderator: – TÜV SÜD Medical Health Services
Moderator: – Qserve Group
Presenter: – European Commission
Presenter: – TUV SUD Product Services
Presenter: – BSI
Presenter: – Federal Agency of Medicines and Health products
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Thursday, May 11th
13:45 – 14:45 CESTMDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and IndustryLocation: Pearl 2
Moderator: – Benefits Regulatory Consulting
Presenter: – Ypsomed AG
Presenter: – anteris medical GmbH
Presenter: – EMA
Presenter: – BSI Group
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Friday, May 12th
10:45 – 11:45 CESTMedical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified BodiesLocation: Pearl 1
Moderator: – RQM+
Presenter: – RQM+
Presenter: – TÜV SÜD Product Services
Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Friday, May 12th
14:00 – 15:00 CESTStrategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?Location: Pearl 1
Moderator:
Moderator: – UCB
Presenter: – AstraZeneca
Presenter: – UCB Pharma
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Friday, May 12th
15:30 – 16:30 CESTEuropean Expedited Approval Pathways in a Global ContextLocation: Carmine & Charcoal
Moderator: – Parexel
Presenter: – CSL Behring AG
Presenter: – European Medicines Agency
PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
-
Knowledge Area: Regulatory Strategy Development
-
Thursday, May 11th
09:00 – 10:00 CESTWill the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)Location: Pearl 1
Moderator & Presenter: – Sanofi
Presenter: – European Medicines Agency
Presenter: – European Patients' Forum
Presenter: – AM-Pharma
Presenter: – European Commission
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Thursday, May 11th
10:30 – 11:30 CESTWill the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )Location: Pearl 1
Moderator & Presenter: – Sanofi
Presenter: – European Medicines Agency
Presenter: – European Patients' Forum
Presenter: – European Commission
PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Thursday, May 11th
13:45 – 14:45 CESTCDx 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 AppliesLocation: Pearl 3
Moderator & Presenter: – Qserve group
Presenter: – Guardant Health
Presenter: – AstraZeneca
IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Friday, May 12th
12:00 – 13:00 CESTResearch Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?Location: Pearl 1
Moderator & Presenter: – Integrated DNA Technologies, Inc., a Danaher Company
Presenter: – SOPHiA GENETICS
Presenter: – BSI
IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
-
Knowledge Area: Submission Management
-
Thursday, May 11th
09:00 – 10:00 CESTIVDR Transition: Quo Vadis? – the current realityLocation: Carmine & Charcoal
Moderator & Presenter: – TUV SUD JAPAN LTD
Moderator & Presenter: – MCRA
Presenter: – NSAI
Presenter: – Molecular Health GmbH
Presenter: – Abbott Diabetes Care
Presenter: – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVDDomain: Product Development & RegistrationKnowledge Area: Submission Management
.png)