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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 - Hall Berlin B
09:00 - 09:05
Chairperson Remarks
- Milos Stojkovic - Safety Process Director, Roche
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
- Andriani Daskalaki - Clinical Expert/Regulatory, mdc medical device certification GmbH
10:20 - 11:05
Legacy Devices in Focus: Leveraging Clinical Evidence and PMS Strategy for 2027 Compliance
- Addressing the difficulty of generating sufficient clinical data for legacy devices to meet MDR/IVDR standards
- Exploring how manufacturers can implement robust PMS and post-market clinical follow-up plans amidst resource constraints.
- Examining the lack of alignment and consistency MDR/IVDR interpretations - what are the solutions?
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
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Clinical Evaluations & PMS - Day 3 - Hall Berlin B
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
- Gavin Quigley - Director & Medical Safety Officer, Johnson & Johnson
- Susan Partridge - Clinical Regulatory Lead, BSI
- Folker Spitzenberger - Professor for Regulatory Affairs for medical devices, Unversity of Applied Sciences Lübeck
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
- Mark Grumbridge - Head of Clinical Investigations, MHRA
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