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Day Three – 12 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Day Three – 12 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Clinical Evaluations and Investigations & Performance Evaluations
08:15 - 08:20
Chairperson’s Opening Remarks: Clinical Evaluations and Investigations & Performance Evaluations
- Bassil Akra - CEO, AKRA TEAM GmbH
08:20 - 09:10
Current European Development: Clinical Evaluations & Investigations under EU MDR
- Current regulations for clinical evaluations and investigations for devices
- Considerations for a successful clinical process, including evaluation and investigation
- European guidelines and harmonisation
- Focal points, ongoing work in the MDCG-CIE working group
- EUDAMED CI/PS module, update and the oversight board
- COMBINE, harmonization for European studies under IVDR, MDR, CTR
- Coordinated assessment procedure, Article 78 MDR
- Paul Piscoi - Scientific Policy Officer, European Commission
- Nebojsa Serafimovic - Assessor for Clinical Investigations, Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
09:10 - 09:40
On the Flip Side: Performance Evaluation Requirements under IVDR
- Current regulations for performance evaluations under the IVDR
- Latest updates & on-going work
- Differences across regions
- Key documentation, data points and responsibilities for industry
- Khaudeja Bano - VP, Combination Product Quality, Amgen
09:40 - 10:10
Clinical Investigations and Evaluation: How to Ease Transition to MDR
- Eudamed Clinical Module: overview and status / transparency
- Clinical investigations and PMCF applications: key insights and harmonized approach?
- Diversity of clinical data collection?
- Which improvements from MDCG 2022-14 would be of values to the MDR transition?
- Carine Cochereau, Integra LifeSciences
10:10 - 10:40
Best Practices in the Use of PMCF Surveys
Learning objectives will include:
Understand the importance / role of PMCF within the EU-MDR
Learn about the differing PMCF Survey approaches (Level 4 vs. Level 8)
Take away key learnings / considerations for how to plan a PMCF Survey
Level 4 PMCF Survey Case Study
Appreciate how PMCF surveys are implemented
- Marcus Torr - PMCF / MDR Lead, Purdie Pascoe
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Clinical Evaluations and Investigations & Performance Evaluations
11:10 - 11:55
Data Collection and Sufficiency: What to Collect and What’s Enough?
- Determining data sufficiency under the MDR & IVDR
- Are clinical or performance studies always necessary?
- When can you leverage previous data?
- Best practices for ensuring sufficient data
- Wojciech Bobela - Senior Regulatory Affairs Specialist, Novocure
- Ella Helgeman - Regulatory and Quality Director, Rehaler
- Nunung Nur Rahmah, M.D., Ph.D - Head of Internal Clinical Team, DEKRA
- Katarzyna (Kasia) Koscielska, Ph.D. - Principal Scientist, Real World Data, Roche Diagnostics
11:55 - 12:40
Supporting Indirect Clinical Benefits in Clinical Evaluations
- Overview of Direct vs. Indirect Clinical Benefits and the challenges
- Defining Safety and Performance Outcomes and Acceptance Criteria for Indirect Clinical Benefits
- Leveraging Safety and Performance Standards vs. Clinical Literature
- Adam Kleinman - Senior Medical Writer, Philips
- Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
- Golddy Kaur - President, MedTech Regulatory Strategist
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Clinical Evaluations and Investigations & Performance Evaluations
14:10 - 14:15
Chairperson’s Afternoon Remarks: Clinical Evaluations and Investigations & Performance Evaluations
- Bassil Akra - CEO, AKRA TEAM GmbH
14:15 - 15:15
Harvesting and Using Real-World Evidence (RWE) for Devices & Diagnostics
- Under which regulations can RWE be used?
- Is RWE enough on it’s own or does a clinical trial always need to be carried out?
- Can it be used for both devices and diagnostics?
- Case studies: suitable RWE for differing risk classes
- Examples of collection, analysis and use in technical documentation
- Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
15:15 - 15:45
Spotlight Session: Navigating Clinical Evaluations & Investigations
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
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Clinical Evaluations and Investigations & Performance Evaluations
16:15 - 17:00
An Alternative Perspective: Research-Initiated Studies
- Determining what is and when to use research-initiated studies
- Influence of medical staff in initiating studies
- Benefits of such studies
- Best practices in fostering working relationships with hospitals
- Future impact
- How can utilising research-initiated studies benefit industry and the wider population?
- Sara Edvardsen - Research Scientist - Centre for Medical Devices, Technology and Innovation, St. Olavs hospital, Trondheim University Hospital
- Shelley Jambresic - Group Lead Science & Evaluation, Geistlich Pharma AG
17:00 - 17:45
Ensuring Diverse Representation in Clinical Evaluations & Investigations and Performance Evaluations
- How diverse is clinical and performance data which is currently being collected?
- Is diversity covered in regulation?
- How much obligation is there for collecting diverse data?
- Availability and usability of diverse data
- Importance of enhancing diversity moving forward
- Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
- Maya Balamane - Senior Clinical Scientist, Intuitive
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