Cours et événements à venir

23/09/2021

Health Economic Evaluations for medical devices companies

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28/09/2021

Update on GDPR for medical devices companies

All medical devices companies process personal data. Since the adoption of the General Data Protection Regulation (GDPR) in May 2018, businesses are facing many challenges and must adapt their data protection practice to avoid significant fines imposed by authorities in case of non-compliance or data breaches. This training – focused on the Life Sciences sector – will provide an update on the most recent trends, guidelines, and recommendations since the adoption of the GDPR. It will also cover the relevant provisions under the Belgian Act of 30 July 2018 implementing the GDPR. The training will finally address some data privacy challenges when using new technologies, such as blockchain.
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05/10/2021

Distribution of medical devices under the MDR

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12/10/2021

Towards more value based health care in Belgium?

Our health care system is under great pressure and the COVID-19 crisis makes it even clearer that we need to rethink the current model to ensure a more sustainable, affordable and patient-oriented health care system. The continuous evolution towards a Value-Based Health Care (VBHC) approach will be an essential part of the solution. During this 2 full days conference, expert speakers will share their knowledge on VBHC, dive into the actual state of play in Belgium and other countries and share their views on the way forward for Belgium.
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22/10/2021

Legislation of medical devices (MDR & Belgian law)

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16/11/2021

Health Data for med tech: sources & opportunities

The use of real-world evidence (RWE) based on RWD can support market access decisions, reimbursement strategies, and comparative effectiveness. To reach the full potential of RWD/RWE, however, certain issues must be addressed. Which source data can be used? What about access and interoperability? How can data quality be guaranteed? Will all healthcare partners accept the RWD/RWE outcomes and incorporate them in their decision process? What are the consequences of the General Data Protection Regulation (GDPR)? During this day, we will focus on the first issue and various accessible databases with Belgian health data will be presented. The data owners explain the databases and the concrete procedure to request the data, if applicable. Some use cases will also be discussed.
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19/11/2021

Legislation IVDR + impact new regulation

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23/11/2021

General Assembly

Members only!
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30/11/2021

Advertising of medical devices (including use of social media)

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14/12/2021

Class I medical devices

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