MD/IVD Regulations from a Patients' Perspective
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IPPOSI CEO Derick Mitchell presents at the 2022 Medtech QA/RA Conference on 12 October 2022.
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MD/IVD Regulations from a Patients' Perspective
- 1. The MD/IVD Regulations from a patients’ perspective Derick Mitchell IPPOSI October 12th, 2022
- 2. Who are IPPOSI? We are a patient-led organisation that works with patients, science & industry to put patients at the heart of health innovation. www.ipposi.ie info@ipposi.ie @IPPOSI
- 3. What do we do, and how? • Digital discussions • In-person conferences • Training programmes • Matchmaking • Member resources • Coalitions and networks • Citizens’ juries EDUCATION ADVOCACY INFORMATION 50/50 public : private funding
- 4. IPPOSI and Medical Devices MDR/IVDR an opportunity for EU to act as a role model for patient engagement, stirring culture change globally!
- 5. PPI Training – both patients & developers EUPATI, the European Patients’ Academy, has expanded its work to include medical technologies BioInnovate / CURAM / PPI Ignite, NUI Galway
- 6. New generation of educated / expert patient leaders • Graduates of patient education are more confident, more willing to engage • Need access to information and to opportunities • Equally: Patient leaders need to be accommodated, supported and compensated, commensurate with their expertise
Hinweis der Redaktion
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- 2019 – conference on EHRs 2021 – three digital discussions on digital health: Ireland’s preparedness, European commitments, Citizen/patient involvement – we also hosted three podcasts around the topic 2021 – coalition around COVID-19 vaccines. 2021 – citizens’ jury on access to health information for secondary purposes 2022 – citizens’ jury on the future use of genomics in healthcare and research in Ireland Ongoing – modules on clinical trials, medicines regulation, health technology assessment – and soon research ethics – and digital health Ongoing – match patients completing our training with available PPI opportunities Ongoing – prepare resources to help members with their own education or advocacy – e.g. PPI mapping, national and EU consultation responses, toolkits and briefing notes Ongoing – campaign to raise awareness about the importance of building a digital health future Ongoing – network of graduates and ENP linked to EUPATI
- Policy environment in Europe is switching towards patient focus, engagement, and transparency Patient voices must be recognised and put first! Massive opportunity to influence health research - beyond the MDReg and beyond devices regulation Key elements for IPPOSI are that recommendations don’t reflect what is now in (for example) the Clincial Trials Regulation – which commits to include patient engagement throughout the process of development and dissemination of Lay Summaries for adult and paediatric clinical studies.
- – equipping patients and stakeholders for a new era of partnership BioInnovate + NUI Galway conducting PPI Training for Medical Device industry