Tweets by RAPS Euro Convergence 2023

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IVDR

Medical Devices

Thursday, May 11th

09:00 – 10:00 CEST

Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data

Location: 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

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: – 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

Supported by

Thursday, May 11th

10:30 – 11:30 CEST

Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER

Location: Pearl 2

Moderator: – Qserve Group

Presenter: – Qserve Group

Presenter: – GymnaUniphy

Presenter: – Qserve Group

Medical DevicesDomain: Scientific & Health ConceptsKnowledge Area: Application of Scientific & Clinical Advances

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: – Ypsomed

Presenter: – Qserve Group

Presenter: – 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: – Qserve Group

Presenter: – BSI

Presenter: – DNV Product Assurance AS

Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Documentation

Supported By

Thursday, May 11th

11:45 – 12:45 CEST

Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI Icebergs

Location: Pearl 1

Moderator & Presenter: – BioSciPons

Moderator & Presenter: – Philips

Medical DevicesDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures

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: – Philips

Presenter: – Siemens Healthineers

Presenter: – confinis AG

Presenter: – confinis ag

Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy

Supported By

Thursday, May 11th

15:00 – 16:00 CEST

Medical Device Regulation in International Perspective: EU IMDRF Chair in 2023

Location: 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

Supported By

Thursday, May 11th

15:00 – 16:00 CEST

Responsibilities and Liabilities in an Interconnected World

Location: Pearl 2

Moderator: – Ypsomed

Presenter: – Philips

Presenter: – Axon Lawyers

Presenter: – Complear

Medical Devices

Supported By

Thursday, May 11th

16:45 – 17:45 CEST

Expert Advisory Panel - What Have we Learned?

Location: Pearl 1

Presenter: – BSI

Presenter: – European Medicines Agency

Presenter: – BD

Medical DevicesDomain: Product Development & RegistrationKnowledge Area: General

Supported By

Thursday, May 11th

16:45 – 17:45 CEST

Regulation 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

Supported By

Friday, May 12th

10:45 – 11:45 CEST

Device Lifetime and Lifecycle Management

Location: 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

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: – RQM+

Presenter: – RQM+

Presenter: – TÜV SÜD Product Services

Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance

Supported By

Friday, May 12th

12:00 – 13:00 CEST

Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective

Location: 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

Supported By

Friday, May 12th

12:00 – 13:00 CEST

UKCA: challenges and opportunities

Location: Pearl 3

Moderator: – Qserve Group

Presenter:

Presenter: – BSI Group

Presenter: – MHRA

Medical Devices

Supported By

Friday, May 12th

14:00 – 15:00 CEST

Standards & Compliance: Updates on ‘Sustainable’ Medical Devices

Location: Pearl 2

Moderator: – Philips

Presenter: – BSI

Presenter: – Boston Scientific

Medical DevicesDomain: Scientific & Health ConceptsKnowledge Area: Healthcare Leadership

Supported By

Friday, May 12th

15:30 – 16:30 CEST

Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since Publication

Location: 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

Supported By

Friday, May 12th

15:30 – 16:30 CEST

Cybersecurity: Compliantly Securing our Healthcare Future

Location: Pearl 3

Moderator & Presenter: – MedSec LLC

Medical DevicesDomain: Product Development & RegistrationKnowledge Area: Market Strategy

Supported By

Pharmaceuticals

Wednesday, May 10th

08:00 – 16:00 CEST

Be ready for EU CTR: Strategy, Systems and Lessons Learned

Location: Saffron (1st fl)

Workshop Leader: – Thermo Fisher Clinical Research Group

Presenter: – Portuguese National Ethics Committee for Clinical Research (CEIC)

Presenter: – PPD, part of Thermo Fisher Scientific

Preconference WorkshopPharmaceuticals

Wednesday, May 10th

08:30 – 16:00 CEST

Workshop: Global Regulatory CMC Strategies and Challenges for Biologicals

Location: Lavender (1st floor)

Workshop Leader: – argenx

Presenter: – BioNTech, Germany

Preconference WorkshopPharmaceuticals

Thursday, May 11th

09:00 – 10:00 CEST

Will 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

Supported by

Thursday, May 11th

10:30 – 11:30 CEST

Will 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

Supported By

Thursday, May 11th

11:45 – 12:45 CEST

Making full use of early access and regultatory tools available to ATMPs

Location: Carmine & Charcoal

Moderator: – Sartorius Stedim Biotech GmbH

Presenter: – Neurogene

Presenter: – European Medicines Agency

PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures

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: – Benefits Regulatory Consulting

Presenter: – Ypsomed AG

Presenter: – anteris medical GmbH

Presenter: – EMA

Presenter: – BSI Group

PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance

Supported By

Thursday, May 11th

15:00 – 16:00 CEST

Regulatory 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

Supported By

Thursday, May 11th

16:45 – 17:45 CEST

EU Regulatory CMC Strategies and Challenges

Location: Carmine & Charcoal

Moderator & Presenter: – Parexel

Presenter: – argenx

Presenter: – European Medicines Agency

PharmaceuticalsDomain: Business AcumenKnowledge Area: Industry-specific Knowledge

Supported By

Friday, May 12th

10:45 – 11:45 CEST

EMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future Directions

Location: 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

Supported By

Friday, May 12th

12:00 – 13:00 CEST

Will 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

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:

Moderator: – UCB

Presenter: – AstraZeneca

Presenter: – UCB Pharma

Presenter: – European Medicines Agency

PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance

Supported By

Friday, May 12th

15:30 – 16:30 CEST

European Expedited Approval Pathways in a Global Context

Location: Carmine & Charcoal

Moderator: – Parexel

Presenter: – CSL Behring AG

Presenter: – European Medicines Agency

PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance

Supported By

Preconference Workshop

Wednesday, May 10th

08:00 – 16:00 CEST

Be ready for EU CTR: Strategy, Systems and Lessons Learned

Location: Saffron (1st fl)

Workshop Leader: – Thermo Fisher Clinical Research Group

Presenter: – Portuguese National Ethics Committee for Clinical Research (CEIC)

Presenter: – PPD, part of Thermo Fisher Scientific

Preconference WorkshopPharmaceuticals

Wednesday, May 10th

08:30 – 16:00 CEST

IVDR Rollout 2023: Innovation vs Legacy: How to define a Clinical Evidence Strategy for an established analyte/marker or technology versus a novel product.

Location: Cyan (1st fl)

Workshop Leader: – NAMSA

Presenter: – Inivata (a subsidiary of NeoGenomics)

Presenter: – Tüv Süd

Preconference WorkshopIVDR

Wednesday, May 10th

08:30 – 16:00 CEST

PMCF Workshop: how to collect valuable data and use it to your benefit?

Location: Charcoal (1st floor)

Workshop Leader: – QServe Group

Presenter: – Med-Clinical

Presenter: – Purdie Pascoe

Preconference WorkshopDevices

Wednesday, May 10th

08:30 – 16:00 CEST

Risk Management Workshop

Location: Carmine (1st fl)

Workshop Leader: – Validant

Presenter: – Qserve Group

Presenter: – Elekta

Presenter: – TÜV SÜD Product Service GmbH

Presenter: – EVIDERA

Preconference WorkshopDevices

Wednesday, May 10th

08:30 – 16:00 CEST

UDI / EUDAMED Workshop

Location: Coral (1st fl)

Workshop Leader: – Medical Device Project B.V.

Presenter: – Medtronic

Preconference WorkshopDevices

Wednesday, May 10th

08:30 – 16:00 CEST

Workshop: Global Regulatory CMC Strategies and Challenges for Biologicals

Location: Lavender (1st floor)

Workshop Leader: – argenx

Presenter: – BioNTech, Germany

Preconference WorkshopPharmaceuticals

Regulatory Business