Day Five – 14 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
Day Five – 14 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
- Miloš Stojković - Safety Process Director, Roche
- From clinical evaluations, to post-market surveillance, to risk management: How do these Standard Operational Procedures (SOPs) feed into each other?
- How would cross-departmental development and delivery enhance working efficiency?
- Shared experiences: breaking bread with breaking silos
- Rina Sant - Associate Director, Post-Market Clinical Oversight, Abbott
- Current regulations regarding PMS activities for devices
- Similarities and differences
- Key documentation
- What's working?
- Current successes and challenges in meeting PMS requirements
- On-going work and future expected guidance
- Sietske Eerens - Senior Inspector, Dutch Health and Youth Care Inspectorate (IGJ)
- Stephanie Berger - BPO PMS, Philips Healthcare, Germany
- What do we know about the latest guidance released for PMS and PSURs?
- Has this helped industry to gain a more comprehensive understanding of the requirements?
- How can manufacturers infiltrate this guidance into their day-to-day responsibilities?
- Sabrina Aït Allek - Quality Assurance & Regulatory Affairs Director, Stilla Technologies
- How do regulatory affairs teams stand to change with the increasing incorporation of AI/ML?
- Which skills need to take the forefront when working with SaMDs and AI/ML?
- How can AI be harnessed to enhance internal processes?
- In the next 10 years – where do we see AI/ML going?
- Are regulatory affairs teams at risk of being overtaken by AI/ML?
- Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
- Melanie Donguy - Head Regulatory Affairs Radiology Medical Devices EMEA, Bayer
- Cybersecurity in regulations
- Who owns the cybersecurity of the device or diagnostic?
- Incorporation of cybersecurity in the entire product lifecycle
- Testing of cybersecurity
- Identifying and overcoming weaknesses
- Enhancing overall security
- Alexander Stock - Project Manager IVD Medical Device Testing, TÜV SÜD
- Pat Baird - Senior Regulatory Specialist, Philips
- Which regulations and standards are applicable to AI-specific QMS?
- Do they differ largely from static devices or diagnostics?
- Working examples: end-to-end process of developing QMS with AI/ML
- Opportunities and challenges in development and application
- Eric Henry - Senior Quality Systems and Compliance Advisor, King & Spalding
- Lindsey Zocolo - Global Program Manager, Medical Device Testing, TÜV SÜD
- Regulatory considerations in early development
- Access publicly available databases early on
- “Can you sell me this pen?” Three easy steps to develop an initial regulatory, quality, and clinical strategy and then sell it to senior management.
- Establishing and initiating the project
- Mapping out timelines, responsibilities, and management
- Records management and documentation
- Identify ways to incorporate quality planning into a project
- Common myths, best practices, and tools – Lessons learned
- Discuss key regulatory requirements and guidelines that impact manufacturers in terms of post market risk management
- Highlight best practices for implementing robust post-market surveillance based risk management strategies to monitor and assess the safety and performance of medical devices.
- Share insights on leveraging real-world data (reactive and proactive), including adverse event reporting, user feedback, and other sources, to enhance surveillance effectiveness.
- Discuss tools, frameworks, and case studies that demonstrate effective risk analysis, including proactive identification of emerging risks.
- Discuss strategies for continuous improvement in post-market risk management, emphasizing the integration of feedback loops, continuous monitoring, and iterative risk mitigation processes.
- Jayet Moon - Quality Manager, Post Market Surveillance and Vigilance, Terumo Medical Corporation
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
- Key QMS processes to consider for the development of AIMD products
- Challenges and tips to obtaining QMS certification for a small organisation
- Q&A
- Eric Qin - Head of Global RA/QA, Franklin-AI
- Which regulations and standards apply to your device?
- Establishing and monitoring standards in medical device project management
- Incorporating regulatory requirements and considerations throughout the medical device lifecycle (clinical evaluation, safety, and risk management)
- Additional regulatory considerations for project management (quality system requirements, design control, vendor control)
- Common myths, best practices, and tools – Lessons learned
- Guidance for overall Post Market Surveillance activities
- Correlation between adverse event, incidents, claims and Post Market Surveillance Report
- Successful data gathering from different tools and embedding into the Post Market Surveillance Report
- Dilşat Pınar Pergjetani - Chief Quality & Regulatory Affairs Officer, Human Care HC AB
- Fayez Abou Hamad, MD - MD, PMS & Vigilance Expert. Owner and Founder of “MDV-Solve” Medical Device Consulting Firm Clinical evaluation, Risk management, PMS & MDR implementation expertise., Terumo Europe N.V., Belgium
- Introduction to Device Constituents of Combination Products
- US FDA Post-Market Device Safety Reporting Final Rule
- Key Learnings & Implementation Opportunities
- Josep Pané - Head of Device and Digital Vigilance and Safety, UCB
- Which requirements are in place regarding PSURs and SSCPs?
- Are they relevant to both the MDR and IVDR
- How do they both feed into each other?
- Further link to PMS plans, PMCF and PMPF
- End-to-end development of the documents
- Bassil Akra - CEO, AKRA TEAM GmbH
- Rikke Lewinsky - Senior Clinical Surveillance Scientist, Radiometer Medical
- Preparing a NHS Wales digital organisation for MDR readiness
- How do we map out MDR requirements?
- What obstacles need solutions?
- On-going work
- What does the future hold?
- How do we maintain compliance and increase development within a publicly funded resource envelope?
- Jamie Manning - Quality Manager (Regulatory Compliance), Digital Health and Care Wales
- Risk based approach in classification of Medical Device Software and application of GDPR to databases created thanks to pilot clinical trials, promoted by startup companies and spinoff companies
- Interpreting the AI Regulation for startup and spinoff companies in their development from research project to commercial product
- Impact of the regulatory burden in the relationship with investors
- Alice Ravizza - Founder, InsideAI
- Interpreting PMS requirements for AI/ML
- Do these differ to traditional medical devices and diagnostics?
- Considerations for static and non-static algorithmic devices and diagnostics
- On-going data collection
- Utilising data effectively
- How could cloud based systems enhance PMS plans?
- Zuzanna Kwade - Clinical Evaluation Lead, Dedalus HealthCare
- Lindsey Zocolo - Global Program Manager, Medical Device Testing, TÜV SÜD
- Practicalities of risk management
- Benefit-risk analysis – the unsolvable equation
- Common myths, best practices, and tools – Lessons learned
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
Take the opportunity to have your remaining unanswered questions discussed with our array of experts before the conference ends!
- Rina Sant - Associate Director, Post-Market Clinical Oversight, Abbott
- Fatima Sanfourche - Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
Take the opportunity to have your remaining unanswered questions discussed with our array of experts before the conference ends!
- Leo Hovestadt - Director Governmental Affairs EU, Elekta
- Erik Vollegbret - Partner, Axon Lawyers
- Koen Cobbaert - Senior Manager Regulatory Science & Policy, Philips
- Bunty Kundnani - Head of Regulatory Affairs, Qure.ai
- Metrics used for project management
- Metrics used for notified body performance
- Adapting to change – significant changes will occur
- Understanding full lifecycle expectations
- Discuss how to optimize team performance, communication, and interaction
- Common myths, best practices, and tools – Lessons learned