JoinHealth - Spring welcome series 2024

abril - maio 2024

JoinHealth - Spring welcome series 2024

Sobre

JoinHealth - Spring welcome series
O próximo ciclo de webinars JoinHealth spring series decorre entre os meses de abril e maio, trazendo para a agenda um conjunto de temas no âmbito do projeto DigiHealthPT. Clique no link de cada webinar e garanta já a sua inscrição:

Os webinars JoinHealth Spring series de 2024 prometem uma visão abrangente das transformações, desafios e oportunidades na saúde digital, no âmbito do projeto DigiHealthPT. Contamos com a vossa participação nestas sessões, que serão conduzidos em inglês, e proporcionarão uma valiosa oportunidade de aprendizagem e networking para os profissionais do setor.

 

Programa

02:30 PM

Understanding Medical Devices Regulation

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Opening 

  • Patrícia Patrício
    Health Cluster Portugal
  • Marta Passadouro
    EIT Health Innostars
02:35 PM

Essential steps for CE mark

02:55 PM

Q&A

03:05 PM

Technical and usability requirements according to the MDR: Case study

03:25 PM

Q&A

03:35 PM

CE Marking Success Story: Difficulties in the transition from Directive 92/43/CE to European Regulation 2017/745

03:50 PM

CE Marking Success Story: Mastering European Regulation 2017/745 for the first time

04:05 PM

Q&A and general discussion with the speakers

04:15 PM

Closing

02:30 PM

How to get your Digital Therapeutics (DTx) reimbursed in Europe

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Opening 

  • Patrícia Patrício
    Health Cluster Portugal
02:35 PM

Early Access to Reimbursement for Digital Medical Devices (PECAN) in France

  • Vincent Vercamer
    Project Director – Market Access expert, Digital Health Delegation, French Ministry of Health
02:55 PM

Q&A

03:10 PM

The Belgian mHealth reimbursement framework: an exercise in digital care pathways

03:30 PM

Q&A

03:45 PM

Hope Care's Experience with the Reimbursement Systems in France and Germany

04:00 PM

Q&A and general discussion

04:10 PM

Closing

02:30 PM

AI Act and the impact in Medical Devices Regulation

Opening 

  • Patrícia Patrício, Health Cluster Portugal

  • Marta Passadouro, EIT Health Innostars

02:35 PM

Software as a Medical Device: Good Practices 

Topics:

  • The importance of establishing requirements: identifying stakeholders, elicitation techniques, establishing traceability

  • Good practices for coding: coding styles and documentation, use of version control and code branching strategies

  • Testing strategies and methodologies: mastering the art of test cases, tools for automating tests

  • Cybersecurity and interoperability: general concerns

02:50 PM

AI Software: Good Practices

Inês Lopes, Fraunhofer Portugal

Topics:

  • The importance of best practices in the AI regulatory landscape.

  • Guidance measures AI system stakeholders can undertake at governance, process, and product levels.

  • Tools supporting the development of responsible AI systems.

03:05 PM

Q&A

03:15 PM

European Regulation for Software as a Medical Device

Sandra Balseiro, IPN

Topics:

  • Define SaMD and an overview of the specific regulations governing SaMD

  • Explain the classification criteria for SaMD and examples of SaMD classifications and their regulatory implications

  • Challenges and considerations associated with regulating SaMD (Data security and privacy concerns; software updates)

03:30 PM

European Regulation and AI ACT

Ana BritoIPN

Topics:

  • AI ACT and its implications for medical devices, including SaMD.

  • Similarities/Complementarities between AI ACT with MDR/IVDR requirements:

  • Requirements for bringing MDs/IVDs with AI systems to the European market

  • Conformity assessment and obtaining CE Marking for MDs/IVDs with AI components 

03:45 PM

Q&A

03:55 PM

Real world Example: Peeking Window 

Cristiana Braga, Filipe SoaresFraunhofer Portugal

 

04:05 PM

Real world Example: Digestaid

Miguel Mascarenhas

04:15 PM

Q&A and general discussion with the speakers

04:30 PM

Closing

02:30 PM

Mastering Clinical evaluation for Medical Devices

Opening 

  • Patrícia Patrício, Health Cluster Portugal
  • Marta Passadouro, EIT Health Innostars

 

02:35 PM

Understanding regulatory requirements for clinical evaluation

Sandra Balseiro/Celeste Oliveira, Instituto Pedro Nunes

Topics:

  • Definition and importance of clinical evaluation in medical device development
  • Clinical evaluation considerations integrated into the design and development process
  • Regulatory requirements and guidelines for clinical evaluation
  • Strategies for achieving regulatory compliance throughout the clinical evaluation process.
03:00 PM

Clinical Investigation with Medical Devices: Life-cycle phases

Lúcia Domingues/Catarina Silvério, NOVA CRU

Topics:

  • Overview of the clinical investigation life-cycle phases 
  • Key factors of each phase
  • Safety assessment and management throughout the clinical investigation
03:25 PM

Q & A

03:40 PM

Real-world Experience of Insparya

João Leite, Insparya

 

03:55 PM

Real-world Experience of C-mo Medical Solutions

Sara Lobo, C-mo Medical Solutions

 

04:10 PM

Q & A and general discussion with the speakers

04:30 PM

Closing

Organização

Co-financiado por