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Day Five – 14 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Day Five – 14 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Post-Market Surveillance and Vigilance
08:30 - 08:40
Chairperson’s Opening Remarks: Post-Market Surveillance and Vigilance
- Miloš Stojković - Safety Process Director, Roche
08:40 - 09:10
A Cross-Functional Challenge: Breaking Down SOP Silos
- 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
09:10 - 09:55
What’s Going On? An Update on Post-Market Surveillance (PMS) Requirements for Devices
- 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 - PMS EUMDR Lead - PMS Process and Governance, Philips Healthcare, Germany
09:55 - 10:40
MDCG Guidance Update: PMS & PSURs for IVDs
- 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
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Post-Market Surveillance and Vigilance
11:10 - 11:55
Post Market Risk Management in the Age of EU MDR
- 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
11:55 - 12:25
Spotlight Session: Navigating Post Market Surveillance and Vigilance
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
Showing 1 of 1 Streams
Post-Market Surveillance and Vigilance
13:25 - 13:30
Chairperson’s Afternoon Remarks: Post-Market Surveillance and Vigilance
13:30 - 14:00
How to Prepare a Beneficial and Efficient Post Market Surveillance Report
- 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 - PMS & Vigilance Expert Consultant – Pharmacist, Terumo Europe N.V., Belgium
14:00 - 14:30
Implementation Opportunities with Post-Market Device Safety Reporting for Combination Products
- 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
14:30 - 15:15
Decoding Periodic Safety Update Reports (PSURs) and Summary of Safety and Clinical Performances (SSCPs)
- 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
Showing 1 of 1 Streams
Post-Market Surveillance and Vigilance
15:45 - 16:15
Spotlight Session: Navigating Post Market Surveillance and Vigilance
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panelist, moderator or hosting a webinar
16:15 - 17:00
Ask the Experts – Clinical Evaluations & Investigations and Post-Market Surveillance
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
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