Como cada año no te pierdas este evento, con la asistencia de profesionales europeos, los Organismos Notificados, …
os ponemos alguno de los puntos fuertes del programa …
PROGRAMA
16:30 – 18:30 CEST Euro Convergence 2024 Welcome & Opening Plenary : Regulatory Affairs: Science or Art?
Moderators: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
– Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V.
Panelists: Elizabeth Gfoeller, MA – MED-EL
– Flora Giorgio – European Commission
– Bodo Mestmacher – TÜV NORD CERT GmbH
7 Mayo 2024
08:30 – 09:30 CEST Biocompatibility: Substances of Concern– Have You Checked? GSPR 10.4 a Practical Guide
08:30 – 09:30 CEST Kick-off MDR Panel Moderator: Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V.
08:30 – 09:30 CEST Patient Access: Regulatory, HTA and Patient Perspectives on an Orphan Drug – Case Study of Erythropoietic Protoporphyria
08:30 – 09:30 CEST The EU’s AI Act: Understanding the challenges to AI-enabled Medical Devices conformity assessments .
08:30 – 09:30 CEST The IVDR Clock is Ticking… But Should There be Alarm?
09:50 – 10:50 CEST Artificial Intelligence in the context of the IVDR – How to keep the revolution under control.
09:50 – 10:50 CEST Clinical Evaluation: Unifying Clinical Evaluation Requirements: Exploring ISO 18969 and the «new MEDDEV 2.7/1»
09:50 – 10:50 CEST Clinical Performance Studies Under IVDR
09:50 – 10:50 CEST Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions
09:50 – 10:50 CEST New EU Pharma Legislation
09:50 – 10:50 CEST Regulatory Leadership: Digitization & Digital Health – There is NO Turning Back!
10:50 – 11:30 CEST Refreshment Break in Exhibit Area on all Levels
11:30 – 12:00 CEST UK Market: PMS and Vigilance Requirements for IVDs
11:30 – 12:30 CEST AI Act: The MDR and The AI Act: A Match Made in Heaven or The Odd Couple?
11:30 – 12:30 CEST Career Development: Forging a Career Path in the Age of Technology
11:30 – 12:30 CEST Key trends impacting HTA and Regulatory interface
11:30 – 12:30 CEST The MDR hurdle for startups and innovation – and strategies to overcome it
11:30 – 12:30 CEST UK MDR: Current State of Play and Future Perspectives
12:00 – 12:30 CEST IVD Usability and Human Factors Studies- Considerations During Pre-market Submission, Similarities and Differences Between the US and Europe
12:30 – 13:00 CEST Solutions Circle: RA-GPT – The Future of the Regulatory Profession
12:30 – 13:00 CEST Solutions Circle: The Time is Now: The Journey to Becoming RCC Certified!Presenter: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
12:30 – 13:00 CEST Solutions Circle: What Can Manufacturers Learn From Effective PMS/PMPF Strategies to Strengthen Their CE With The IVDR Transition Deadline Approaching?
12:30 – 13:45 CEST Chapter/Local Networking Group Meet and Greets
12:30 – 13:45 CEST Networking Lunch in Exhibit Hall on all Levels
13:15 – 13:45 CEST Solutions Circle: How to Distinguish General and Specific PMCF Activities
13:15 – 13:45 CEST Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) According to The IVDR
13:25 – 13:55 CEST Sponsored Presentation: Transitional provisions of the IVDR – Can I sit back and relax?Presenter: Pieter Bogaert, PhD – Qarad
13:25 – 13:55 CEST Sponsored Presentation: Clearing up EUDAMED confusion for medtech regulatory teamsPresenter: Adam Price – Rimsys
13:45 – 14:45 CEST IVDR Class D Devices – Latest Updates & Experience
13:45 – 14:45 CEST Meeting EMA and FDA: Formal and informal pathways, in search of alignment
13:45 – 14:45 CEST Randomized Clinical Trials vs. Validation Cohort studies of AI/ML-based SaMDs: what are the differences and guidelines for appraisal of the clinical evidence?
13:45 – 14:45 CEST Standards and Compliance
13:45 – 14:45 CEST Unveiling Insights: Navigating the public disclosure of clinical trials in an evolving industry
15:05 – 16:05 CEST CDx or Not CDx That is The Question – The Impact of The IVD Regulation on IVDs Used in Pharmaceutical Clinical Trials
15:05 – 16:05 CEST From China to WHO: Strategies & Updates to Accelerate China & WHO Drug Approvals and Master Files
15:05 – 16:05 CEST MDR Art. 117 for Combination Products. Are the challenges solved now? State of Play from EMA, NB and IndustrySession Leader/Speaker: Stephan Affolter –
15:05 – 16:05 CEST Post-market requirements: Keeping PSUR and SSCP up to date
15:05 – 16:05 CEST Securing AI solutions in MedTech products
15:05 – 16:05 CEST Use of Real World Evidence for Regulatory Making for Medical Devices & Diagnostics in EU: A Practical Guide
16:05 – 16:45 CEST Coffee Break in the Exhibit Hall on all Levels
16:10 – 16:40 CEST Sponsored Presentation: Leveraging AI for Successful Clinical Evaluation and PMCF StrategiesPresenter: Shruti Sharma – Celegence
16:10 – 16:40 CEST Sponsored Presentation: MDR has come: A call for a proactive boost in Medtech Innovation IndustryPresenter: Alessandro Malaspina – 1 MED
16:10 – 16:40 CEST Sponsored Presentation: Regulatory Intelligence: From information overload to strategic decision-makingModerator: Diogo Geraldes
16:10 – 16:40 CEST Sponsored Presentation: Using Clock Stops Wisely to Appropriately Address CHMP Issues – Why Time MattersPresenter: Bert Regeer, MD – 3D Communications
16:45 – 17:45 CEST Don’t get orphaned: how to be novel in the IVDR environment.
16:45 – 17:45 CEST Importance of New Active Substance status for biologics, and CMC strategies for development of C&G therapies
16:45 – 17:45 CEST Navigating the future: Embracing AI and ChatGPT in Regulatory Affairs and Quality Management for Pharma and MedTech Professionals alike
16:45 – 17:45 CEST Pre-clinical evaluations and clinical investigations. Strategizing towards efficiency and new approaches including in silico methods
16:45 – 17:45 CEST Regulators and Industry perspective on Use of Artificial Intelligence in the Drug Development Lifecycle
16:45 – 17:45 CEST Scientific Advisory Panel
18:30 – 22:00 CEST Euro Convergence Networking Dinner (ticket required)
8 Mayo 2024
08:30 – 09:45 CEST Conversations That Matter: Interactions with Health Authorities
09:45 – 10:25 CEST Coffee Break in the Exhibit Hall on all Levels
10:25 – 11:25 CEST Application of article 61(10), non-clinical data, for SaMD and AI
10:25 – 11:25 CEST Career Development: Live LinkedIn review Session
10:25 – 11:25 CEST CTA with Devices: State of Play for non-CE Marked Diagnostic Tests in European Clinical Trials
10:25 – 11:25 CEST Tackling Regulatory Challenges in a Global Marketplace: Developing a Robust Performance Evaluation Strategy for IVDs
10:25 – 11:25 CEST Collaboration Works: Risk Management – Clinical Evaluation – PMS/PMCF United
10:25 – 11:25 CEST The Paradigm Shift in the EU Market Approval of Devices and IVDs – a Hot Potato?!
11:45 – 12:45 CEST Clinical Evaluation: Complexity in Simplicity: Regulatory Challenges for Standard of Care Medical Devices
11:45 – 12:45 CEST Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
11:45 – 12:45 CEST Environmental Regulation: How EU Green Deal and Other Environmental Regulations Affect Medical Devices and IVDs
11:45 – 12:45 CEST Maintaining Compliance: IVDR Post-Certification Activities
11:45 – 12:45 CEST Patient-Centric Endpoints and Use of Digital Health Technologies
11:45 – 12:45 CEST Supply Chain/Shortage
12:45 – 13:15 CEST Solutions Circle: Cyber Security – Pitfalls for IVDR Technical File Submission
12:45 – 13:15 CEST Solutions Circle: Essentials of EU Regulatory Intelligence; Overview of Key Aspects of Regulatory Intelligence
12:45 – 13:15 CEST Solutions Circle: How Does the SSCP Improve Patient Safety in Less Than 100 Pages?
12:45 – 14:00 CEST Chapter/Local Networking Group Meet and Greets (C Level)
12:45 – 14:00 CEST Networking Lunch in Exhibit Hall on all Levels
13:25 – 13:55 CEST Sponsored Presentation: Consolidating Economic Operators for Market Access GloballyPresenter: Daniëlle Sleegers – MedEnvoy Global
13:25 – 13:55 CEST Sponsored Presentation: The challenge of the transition: a practical guide on how to use data historicity to produce correct rationales and deal… – Kiwa
13:30 – 14:00 CEST Solutions Circle: Effective Strategies When Approaching Regulatory Due Diligence Under the MDR – NAMSA
13:30 – 14:00 CEST Solutions Circle: Intended Purpose, Device Classification, NB Codes and Corresponding Types of Devices/Sampling TD Under the IVDR
13:30 – 14:00 CEST Solutions Circle:Effective Strategies for High-Quality Clinical Data Collection through Post-market Clinical Follow-Up (PMCF) Surveys and Medical Device Registries
14:00 – 15:00 CEST International Regulatory Frameworks to Accelerate Orphan Drug Registrations
14:00 – 15:00 CEST Data at the Core: Understanding Your Company’s Critical Yet Under-utilized Tool
14:00 – 15:00 CEST Cybersecurity: Integrating Medical Device Cybersecurity in the Quality Management System
14:00 – 15:00 CEST Experience gain from implementing Article 5(5) of the IVDR in a network of European Laboratories
14:00 – 15:00 CEST IMDRF Coding: Complaints, Vigilance, Trend Analysis and the Benefits of Codifying Your Post Market Surveillance System
14:00 – 15:00 CEST Post Market Clinical Studies
15:00 – 15:40 CEST Coffee Break in the Exhibit Hall
15:40 – 16:40 CEST An overview of AI, Software and Cybersecurity regulations in Asia
15:40 – 16:40 CEST IVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?
15:40 – 16:40 CEST Orphan Devices: How to Obtain Orphan or Pediatric Medical Device Approval
15:40 – 16:40 CEST Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a case study
15:40 – 16:40 CEST Structured Dialogue: Innovative Pathways in Europe and UK: a Legal, Manufacturer’s and Notified Bodies Perspective
15:40 – 16:40 CEST Unwanted immunogenicity testing: still challenging after more then 30 years
16:40 – 17:15 CEST Closing Remarks & Farewell Toast
IMPRESIONANTE ….