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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
08:55 - 09:00
Chairperson Remarks
09:00 - 09:45
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 Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Philips
- Tonia Jeiter - Senior Manager Clinical Evaluation and Clinical Lifecycle Management, Alcon
- Barbara Fink - Associate Director of Clinical Affairs, Heartstream
09:45 - 10:15
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at neha.singh@informa.com
10:15 - 11:00
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
Showing 1 of 1 Streams
Clinical Evaluations & PMS - Day 3
11:30 - 12:15
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
12:15 - 12:45
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at neha.singh@informa.com
12:45 - 13:15
UK & PMS: Looking Back and Looking Ahead
- 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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