Full Schedule

08:00 – 16:30 CEST

Cloak Room

Location: Violet

08:00 – 16:30 CEST

Registration Open

Location: Lobby - Ground floor

08:30 – 16:00 CEST

Poster Viewing

Location: Level 1

08:45 – 10:00 CEST

Conversations That Matter: Interactions with Health Authorities

Location: Pearl 1 + 2 + 3

Moderator: – European Medicines Agency

Moderator: – TÜV SÜD Medical Health Service

Panelist: – Austrian Medicines Agency, AGES MEA

Panelist: – European Medicines Agency

Panelist: – EMA

Panelist: – European Medicines Agency

Panelist: – TUV Sud GmbH

Panelist: – BSI

Panelist: – Dutch Health and Youth Care Inspectorate

Panelist: – European Commission

10:00 – 10:30 CEST

Chapter/Local Networking Group Meet and Greets

Location: Foyer 1

10:00 – 10:45 CEST

Refreshment Break in Exhibit Area

Location: Foyer ground floor & 1st floor

10:15 – 10:45 CEST

Presenters at Posters

Location: Foyer - 1st floor

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

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

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

10:45 – 11:45 CEST

Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system

Location: Carmine & Charcoal

Moderator: – BSI

Presenter: – Qserve Group

Presenter: – Constency Healthcare

Presenter: – TUV Sud GmbH

IVDDomain: Post Approval/Post MarketKnowledge Area: General

Supported By

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

12:00 – 13:00 CEST

Research 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

Supported By

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

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

12:45 – 13:45 CEST

Chapter/Local Networking Group Meet and Greets

Location: Foyer 1

13:00 – 14:00 CEST

Lunch, Exhibits, Posters

Location: Foyer ground floor & 1st floor

Sponsored By

13:15 – 13:45 CEST

Sponsored Presentations: Digitized Regulatory Intelligence: Empowering Compliance & Professionals

Location: Pearl 1

Presenter: – MedBoard

Sponsor Presentation

Sponsored By

13:15 – 13:45 CEST

Sponsored Presentations: FDA first, CE later. Clinical and regulatory strategy trends

Location: Pearl 2

Presenter: – QServe Group

Presenter: – Qserve group

Sponsor Presentation

Sponsored By

13:15 – 13:45 CEST

Sponsored Presentations: Global regulatory platform vs integrations: Challenges for data consistency

Location: Coral & Cyan

Presenter: – Ennov

Sponsor Presentation

Sponsored By

13:15 – 13:45 CEST

Sponsored Presentations: Streamlining Regulatory Affairs: Industry trends & Innovations

Location: Carmine & Charcoal

Presenter: – Veeva MedTech

Sponsor Presentation

Sponsored By

13:15 – 13:45 CEST

Sponsored Presentations: The Impact of AI on MedTech: Current and Future Applications

Location: Pearl 3

Presenter: – RQM+

Presenter: – Giotto.ai

Presenter: – RQM+

Sponsor Presentation

Sponsored By

14:00 – 15:00 CEST

Due Diligence: Critical Importance of Regulatory & Quality to Support Company or Product Acquisitions

Location: Pearl 3

Moderator & Presenter: – Ypsomed

Presenter: – Konapharma

Regulatory BusinessDomain: Business AcumenKnowledge Area: General

Supported By

14:00 – 15:00 CEST

Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing Approaches

Location: Carmine & Charcoal

Moderator & Presenter: – TÜV SÜD Product Service GmbH

IVDDomain: Product Development & RegistrationKnowledge Area: Data Management & Analysis

Supported By

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

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

15:00 – 15:30 CEST

Chapter/Local Networking Group Meet and Greets

Location: Foyer 1

15:00 – 15:30 CEST

Chapter/Local Networking Group Meet and Greets

Location: Foyer 1

15:00 – 15:30 CEST

Presenters at Posters

Location: Level 1

15:00 – 15:30 CEST

Refreshment Break in Exhibit Area

Location: Foyer ground floor & 1st floor

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

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

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

15:30 – 16:30 CEST

MDCG22-14 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

Supported By

16:30 – 17:00 CEST

Closing Remarks & Farewell Toast

Location: Patio - outside main entrance

Sponsored By