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Day Five – 20 June 2025 - CEST Time Zone
- Rina Sant - Associate Director, Post-Market Clinical Oversight, Abbott
Current regulatory landscape and expectations for post market surveillance and vigilance in Europe
Have there been any notable changes?
Are there any areas under review to watch out for?
Which sections of PMS guidance consistently trip people up?
Solutions to overcome
With UK PMS regulations having come into force in 2024, what are our first experiences?
Do expectations align with Europe?
Can manufacturers streamline PMS activities for both regions?
Are there common pain points which need addressing?
- Mika Reinikainen - Chairman, Abnovo Ltd., UK
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
Current European regulatory landscape around large language models
Where do LLMs link into other current legislations?
What implications are there for devices and diagnostics?
What is the current impact on patient safety?
LLMs in practice
How can manufacturers deploy them effectively and safely?
- Stephen Gilbert - Professor of Medical Device Regulatory Science, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Where can generative-AI be used for medical devices and diagnostics?
Which areas need to be considered with employment?
Liability
Security by design
Intellectual property
Which practices are in place to ensure safety of using gen-AI?
- Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
- Fabrizio Maniglio - Director, Industry and Business Development, Honeywell
- Bunty Kundnani - Head of Regulatory Affairs, Qure.ai
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
- Ed Woo - Senior Director, Regulatory Affairs APAC, Varian, a Siemens Healthineer Company
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
- Market overview
- Key pathways
- How to access the region
- How to make product launch quicker
- Fast track and key pathways
- Example case study of submission
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
Role of PMS in the Benefit-Risk Framework
Regulatory Expectations for PMS Data Collection
Risk Identification and Management via PMS
Impact of Post-Market Data on Benefit-Risk Decisions
Cross-Functional Collaboration for Effective Benefit-Risk and PMS
- Ella Helgeman - Senior Regulatory Director, Radiometer
How do you decide what Continuous PMCF activity is appropriate for each class of device?
What systems and tools are key for creating?
How do you implement?
Set up a decision tree to help guide your decisions in the PMCF World
Can you Create a Proactive and Maneuverable PMS/PMCF System to be globally supportive
- Rina Sant - Associate Director, Post-Market Clinical Oversight, Abbott
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
- Which standards from TC 42 ( General AI Standards) are applicable to AI-enabled devices?
- Details from the SNAIG reports
- Status of medical standards for AI/ML
- Testing of AI/ML IEC 63450
- Clinical Evaluation of AI/Ml Systems (IEC 63521)
- Status update of PAS on data management and quality assessments for medical devices
- Dominik Kowalski - Project Manager / Regulatory Compliance / IEC Standard Member for AI and Radiotherapy, Brainlab
- Market overview
- Key pathways
- How to access the region
- How to make product launch quicker
- Fast track and key pathways
- Example case study of submission
- Ed Woo - Senior Director, Regulatory Affairs APAC, Varian, a Siemens Healthineer Company
- Rina Sant - Associate Director, Post-Market Clinical Oversight, Abbott
Understanding Real-World Evidence
Integration of RWE in Post-Market Surveillance
Regulatory Landscape
Case studies
Challenges and Opportunities
Future directions
- Dilşat Pınar Pergjetani - Chief Quality & Regulatory Affairs Officer, Human Care HC AB
- Outline of a Practical Approach to Integrating MDCG 2022-21 Requirements: Effective integration into the Quality Management System to meet regulatory demands.
- Utilization of the PSUR Structure for Streamlined Input Templates: Developing department-specific templates to ensure consistent, compliant data collection across teams.
- Breaking Down Silos Through Direct Involvement: Enhancing cross-departmental collaboration by focusing on a unified PSUR project goal, rather than on isolated task completion.
- Fostering a Collaborative Environment: Bridging perspectives across departments to promote a cohesive approach to quality management.
- Kristin Ulbrich - Senior Post-Market Surveillance Specialist, HOYA Surgical Optics
- Josep Pané - Head of Device and Digital Vigilance and Safety, UCB
Latest regulatory updates regarding clinical data in the EU
What do regulators and notified bodies expect?
Are expectations aligned?
Documenting desirable data: a working example
Examples of sufficient and insufficient data
How to collect, harvest and utilise data from trials and real-world
Common pitfalls and methods to overcome
- Bianca Lutters - Head of Clinical Operations, Qserve Group
- The software modules and their clinical validation
- Use of data from clinical trials
- The foreseen Post Market Clinical Follow up activities
- Integrating the quality management system in life cycle management
- Alice Ravizza - Founder, InsideAI
What are PCCPs and are they only of use in the US market?
What are the current requirements of PCCP for AI/ML-enabled devices?
Are they only for AI-enabled devices?
How can manufacturers utilise PCCPs?
Common pain points and tips to avoid these
- Abhineet Jhori - Regulatory Affairs Manager, Siemens Healthineers
- Ed Woo - Senior Director, Regulatory Affairs APAC, Varian, a Siemens Healthineer Company
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
- Market overview
- Key pathways
- How to access the region
- How to make product launch quicker
- Fast track and key pathways
- Example case study of submission
- Sasikala Thangavelu - Adjunct Professor, University Malaya, Malaysia and former Director of Medical Device Authority, Malaysia
Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
What are the current regulatory expectations for adverse event reporting?
How are notified bodies assessing this?
Industry experiences of reporting adverse events
Can current processes be more standardised?
Streamlining stakeholder interactions
Can AI be used to alleviate workload?
- Miloš Stojković - Safety Process Director, Roche
Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any leftover burning questions!
- Leon Doorn - QAIR.io, Independent Regulatory Affairs Consultant
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
- Sasikala Thangavelu - Adjunct Professor, University Malaya, Malaysia and former Director of Medical Device Authority, Malaysia
- Ed Woo - Senior Director, Regulatory Affairs APAC, Varian, a Siemens Healthineer Company