Real world data collection on the efficacy and drug usage of Raxone 150 mg 180 film-coated tablets for treatment of reduced vision in adolescent and adult patients with Leber’s hereditary optic neuropathy
Real world data collection on the efficacy and drug usage of Raxone 150 mg 180 film-coated tablets for treatment of reduced vision in adolescent and adult patients with Leber’s hereditary optic neuropathyWelcome to the technical documentation pages for the project "Real world data collection on the efficacy and drug usage of Raxone 150 mg 180 film-coated tablets for treatment of reduced vision in adolescent and adult patients with Leber’s hereditary optic neuropathy", provided by the service healthdata.be (Sciensano).
These pages provide information about the technical processes of the project. The following sections are (will be) provided:
- General project information
- The data collection
For scientific information of the project, please contact the primary organization that oversees implementation of project (see section "General project information").
This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a support ticket via our portal (https://healthdatabe.atlassian.net/servicedesk/customer/portals) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!General RAXONE project information
General RAXONE project informationProject name
Real world data collection on the efficacy and drug usage of Raxone 150 mg 180 film-coated tablets for treatment of reduced vision in adolescent and adult patients with Leber’s hereditary optic neuropathy
Project abbreviation
Raxone MEA
Project code
HDP0239
Primary organization that oversees implementation of project
- Chiesi Pharmaceuticals
Partner organization participating in project
- Not applicable
Organization that commissioned this project
- National Institute for Health and Disability Insurance (RIZIV-INAMI)
Organization providing monetary or material support
- Chiesi Pharmaceuticals
Brief project description
"Leber’s hereditary optic neuropathy (LHON) is a genetic disease that leads to sudden vision loss during young adult life. LHON is a disorder caused by mutations in the genetic code of the mitochondria, which are small subunits that reside within the cell. Mitochondria constantly convert energy locked in our food into energy that the cell can use.
Brain cells, including the optic nerves, which are particularly energy-demanding, are therefore, more prone to damage if the mitochondria are not able to produce energy properly. A lack of energy production can lead to degeneration and death of retinal ganglion cells (RGCs), which are the nerve cells that communicate visual information to the brain. Loss of these cells leads to subsequent degeneration of the optic nerve and visual loss.
An agreement with Chiesi for the temporary registration of a proprietary medicinal product on the list of reimbursable proprietary medicinal products, in accordance with the provisions of articles 112 to 117 inclusive of the royal decree of 1 February 2018 has been established with the working group for agreements (RIZIV/INAMI) and the Minister of Social Affairs. During the temporary reimbursement of 2 years, the company has to answer 6 questions (included in the agreement) to give an answer to the uncertainties that there are today."
Regulatory framework of this project
Consult the regulatory framework information published on the fair.healthdata.be pages.
The RAXONE data collection
The RAXONE data collectionOrganizations and/or individuals that provide data
Text organizations and/or individuals that provide data
Start date of the data collection
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End date of the data collection
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Periodicity of the data collection
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The RAXONE Dataflow description
The RAXONE Dataflow description manager Wed, 11/06/2024 - 18:53Support service for HD4DP v2
Support service for HD4DP v2 manager Wed, 08/07/2024 - 21:52How to report an incident
How to report an incidentThe healthdata.be service (Sciensano) processes each incident report according to a Standard Operating Procedure (SOP). A public version of this SOP "HD Incident Management Process" is also available on this portal docs.healthdata.be.
To submit an incident related to registries and applications in production and facilitated or managed by Sciensano's healthdata.be service, you must first log into the HD Service and Support portal: Jira Service Management (JSM).
More info concerning how to request an account is available here.
After the login step, you will arrive at the main page of the portal
To create a ticket click on "Create a Support ticket"' on the main page.
You will see the page below. Once you have filled in all the mandatory fields, click on "Send".
Support service of healthdata.be
Support service of healthdata.beThe Service Desk of healthdata.be (Sciensano) helps users of our applications and services and deals with requests and incidents.
The Service Desk focuses on those services run by our IT Services (HD4DP, HD4RES, healthstat.be,...) and helps you with accounts and passwords. For questions about the content and objective(s) of the projects, we kindly refer users to the managing research organizations.
For most efficient processing of your request, we advise you to use our service portal: Jira Service management (JSM).
Please find below our support window hours:
How to report an incident
How to report an incidentThe healthdata.be service (Sciensano) processes each incident report according to a Standard Operating Procedure (SOP). A public version of this SOP "HD Incident Management Process" is also available on this portal docs.healthdata.be.
To submit an incident related to registries and applications in production and facilitated or managed by Sciensano's healthdata.be service, you must first log into the HD Service and Support portal: Jira Service Management (JSM).
More info concerning how to request an account is available here.
After the login step, you will arrive at the main page of the portal
To create a ticket click on "Create a Support ticket"' on the main page.
You will see the page below. Once you have filled in all the mandatory fields, click on "Send".
Submit a request for information about HD
Submit a request for information about HDTo request information about the healthdata.be platform, you first need to log in to the HD Service and Support portal: https://sciensano.service-now.com/sp.
Om informatie op te vragen over het healthdata.be platform, moet u eerst inloggen op het HD Service- en Supportportaal: Jira Service Management (JSM) portal
Email security policy
Email security policyWHAT IS THE PROBLEM?
Sciensano blocks e-mails from organizations if the configuration of their e-mail and/or DNS services allow potential abuse by spammers/attackers. More specifically, if the configuration enables other senders to impersonate your organization by allowing them to mimic your organization’s e-mail “Header From”.
In other words, they can send phishing and spam mails that cannot be distinguished from genuine mails from your organization.
If you’re responsible for managing your ICT infrastructure, keep reading. If not, pass this message on to your ICT department or to the ICT service that’s managing your ICT infrastructure.
HOW TO SOLVE IT?
You’ll have to verify that your configuration complies with “Sender Alignment” security requirements.
More specifically, your mail services and DNS will have to be configured according to ICT standards.
These configurations are common, well-documented and supported by hosting companies. Some useful links:
- https://dmarcian.com/alignment/
- https://mxtoolbox.com/dmarc/spf/spf-alignment
- https://o365info.com/how-does-sender-verification-work-how-we-identify-spoof-mail-the-fiveheros-spf-dkim-dmarc-exchange-and-exchange-online-protection-part-9-of-9/
We’ve noticed that this issue frequently occurs in organizations which moved their ICT infrastructure to cloud services such as Microsoft (O365), Amazon, Google, and MS Azure without properly configuring the ICT infrastructure which is not managed by these providers.
The configurations and recommendations need to be implemented on the customer’s ICT infrastructure, either internally or externally. DNS and Mail services are the main ICT platforms for these actions.
THE USE OF DIFFERENT DOMAINS IN THE MAIL SENDING PROCESS
E-mails contain an “Envelope From” and a “Header From”. Both need to match to avoid that the mail is blocked.
Some examples:
- A public service is using its new domain name in the “Header From” and its old domain name in the “Envelope From”.
- Envelope From = noreply@publicservice.fgov.be
- Header From = noreply@publicservice.belgium.be
➔ These e-mails will be blocked.
Remark: Because it’s a noreply address, the sender will not even be aware of us rejecting the e-mail …
2. An organization is using a cloud service (Freshservice) for its helpdesk tool and the “Envelope From” has not been customised.
• EnvelopeFrom = bounces+us.3.52773-helpdesk=organisation.be@emailus.freshservice.com
• Header From = helpdesk@organisation.be
➔ These e-mails will be blocked.
3. A company uses a cloud service (Amazon SES) to send the delivery notification and the “Envelope From” has not been customized.
- Envelope From = 01020188573f374-96de6437-9134-45f4-8aa6-3e9ac18d5848-000000@euwest-1.amazonses.com
- Header From = noreply@company.be
➔ These e-mails will be blocked.