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Day 3 - Wednesday 17th June - CEST Time Zone
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Day 3 - Wednesday 17th June - CEST Time Zone
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Clinical Evaluations & PMS - Day 3
09:00 - 09:05
Chairperson Remarks
09:05 - 09:50
The Future of Clinical Evidence in the Medical Device Lifecycle
- Exploring the evolving role of clinical evidence in the medical device lifecycle, from development to post-market surveillance, and its impact on regulatory compliance.
- Discussing innovative approaches to generating, managing, and leveraging clinical data to meet the increasing demands of global regulatory bodies.
- Looking into future trends, challenges, and opportunities in clinical evidence generation to support device safety, efficacy, and market success.
- Nebojsa Serafimovic - Assessor for Clinical Investigations, Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
- Adam Kleinman - Associate Director, Medical & Scientific Writing, Philips
- Tonia Jeiter - Senior Manager Clinical Evaluation and Clinical Lifecycle Management, Alcon
- Barbara Fink - Associate Director of Clinical Affairs, Heartstream
10:20 - 11:05
Proactive PMS – How Is This Defined in 2026?
- Exploring innovative tools, technologies, and methodologies shaping the future of PMS to ensure compliance and improve patient safety.
- Perspectives on regulatory expectations and best practices for implementing a forward-thinking PMS strategy.
- Fayez Abou Hamad, MD - PMS & Vigilance Expert Consultant – Pharmacist, Terumo
Showing 1 of 1 Streams
Clinical Evaluations & PMS - Day 3
11:35 - 12:20
Unlocking In Silico Trials in Medical Devices: The Path to Adoption
- Alejandro Frangi - Bicentenary Turing Chair in Computational Medicine / UK CEiRSI Executive Director, University of Manchester
12:20 - 12:50
Beyond the Hype: In Silico Trials in Medical Devices, in Practice
For more information, please contact Neha Singh at neha.singh@informa.com
- Alejandro Frangi - Bicentenary Turing Chair in Computational Medicine / UK CEiRSI Executive Director, University of Manchester
12:50 - 13:20
Clinical Investigations in the UK – Delving into Past Insights and Future Opportunities
- Diving into current challenges and opportunities in aligning PMS practices with UK-specific regulatory requirements
- Exploring future trends and strategies for navigating the UK regulatory landscape while ensuring robust PMS compliance
- Mark Gumbridge - Head of Clinical Investigations, MHRA
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