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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
- Tonia Jeiter - Senior Manager Clinical Evaluation and Clinical Lifecycle Management, Alcon
- Adam Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Phillips
09:45 - 10:15
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
10:15 - 11:00
Clinical Evaluation Updates for Recertification: Leveraging 5 Years of PMS Data
- Examine the latest updates in clinical evaluation requirements for medical device recertification, focusing on leveraging post-market surveillance (PMS) data.
- Discuss strategies for effectively utilizing 5 years of PMS data to demonstrate ongoing compliance and device safety.
- Insights into best practices for integrating PMS findings into clinical evaluation reports to streamline the recertification process.
- Rina Sant - Associate Director, Regulatory Affairs Post-Market Management, Abbott
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 niha.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, MRHA
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