Day Three – November 7, 2024
Day Three – November 7, 2024
- Matthias Fink - Senior Clinical Consultant, AKRA TEAM Inc
Latest regulatory requirements for clinical evidence across US and EU regions
Review of latest MDCG guidance in Europe and impact on industry
How does this compare to US expectations?
Breakdown of requirements on device class
Future readjustment
Can we expect more harmonized regulations across Europe and US?
Priorities for regulators with clinical requirements in 2025 and beyond
- Danyel Carr - Senior Director, Clinical Affairs, Argon Medical
Clinical data requirements – US vs EU
Is there a difference in expectation across regions?
How is sufficient data defined?
Ensuring sufficient data is collected
Can you leverage data from previous devices or other regions?
Examples of rectifying insufficient data
- Matthias Fink - Senior Clinical Consultant, AKRA TEAM Inc
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
- Clinical Evaluation documents – not just the CEP and CER
- Collaborating for Success with Cross-functional Partners
- Compliant, Concise, and Comprehensive Clinical Evaluation
- Continuous Improvement from Notified Body review
- Dona O'Neil - Associate Director, Medical & Scientific Affairs,, BD
- Sarah Williams - Manager, Medical Writing, Medical Affairs, BD
- Brenda Peterson - Medical Writing Manager, BD
- Matthias Fink - Senior Clinical Consultant, AKRA TEAM Inc
Current acceptance of RWE globally
Is 1 region further along in acceptance than another?
Current pathway for using RWE in FDA and European submissions
Expectations of Notified Bodies and Regulators
Case studies: suitable RWE for differing risk classes
Future forecast for harmonization of standards
- Rina Sant - Associate Director, Post-Market Clinical Oversight, Abbott
- Stephen Weber - Assistant Professor, The Johns Hopkins School of Medicine
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
Post-market requirements in US and EU regions
FDA and Notified Body expectations
Best practices for carrying out PMS
Leveraging documentation to enhance working efficiencies
Incorporating risk management strategies
Working cross-departmentally
The future of PMS: how does the future of PMS look for the US and Europe?
- Queenita Fernandes, BHMS, DND, CCH, CPPS - Senior Medical Safety Manager, Medtronic
- Emphasize the importance of utilizing post-market data to inform and improve risk management processes in healthcare.
- Provide strategies for analyzing complaint trends and answering questions related to Clause 10.3 of ISO 14971:2019.
- Highlight the need for continuous feedback of post-production data into risk management to ensure continuous improvement.
- Offer a practical framework for integrating post-market insights with risk management, enhancing patient safety, and continuous improvement.
- Taylor Dieringer - Staff Quality Engineer - Risk Management, iRhythm Technologies, Inc.
Got any questions left over from the previous 3 days? Get your burning questions answered by our experts!
- Gert Bos - Executive Director & Partner, Qserve Group
- Rina Sant - Associate Director, Post-Market Clinical Oversight, Abbott
- Mira Leiwant - Vice President, Regulatory Affairs, Quality, and Clinical Affairs, Anika Therapeutics, Inc.
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers