| The Ministry of Health, the Regions, and AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency]. | Lever
> Leversygdomme: de fleste typer | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 10.000 | National | Regularly | 115023591745 |
| Through submissions to AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] via the Technical Health Committee of the Ministry of Health. | HIV
> HIV | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 1.000 | National | Regularly | 115050875230 |
| The organisation represents patients before national and European regulatory bodies, including AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] and EMA [European Medicines Agency]. | Sjælden
> Sjældne sygdomme: metaboliske/lysosomale | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 1.000 | National | Regularly | 115050896715 |
| Agenas [Agenzia Nazionale per i Servizi Sanitari Regionali – National Agency for Regional Health Services], Ministry of Health, Lazio Region. | Respiratorisk
> Luftveje: de fleste tilstande | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 5.000 | National | Sometimes | 115052531440 |
| Yes. The association represents patients' interests before the institutions and regulatory authorities involved in decision-making processes related to healthcare policy, access to therapies, and the sustainability of the healthcare system. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 100.000 | National | Regularly | 115057561938 |
| The association represents patient interests before the institutions and regulatory authorities involved in decision-making processes relating to health policy, access to therapies, and the sustainability of the healthcare system. In particular, it promotes dialogue with regulatory bodies, healthcare institutions, and health system stakeholders with the aim of contributing to the development of policies that ensure equitable and appropriate access to treatments for people living with rheumatological conditions. This encompasses direct engagement with AIFA [Agenzia Italiana del Farmaco — the Italian Medicines Agency], as well as with regional authorities where dedicated regional working groups on rheumatological and rare rheumatological diseases have been established. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 100.000 | National | Regularly | 115057561938 |
| AISC [Associazione Italiana Scompensati Cardiaci – Italian Association of Heart Failure Patients] maintains frequent engagement with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] and with national and regional decision-makers regarding the introduction and adoption of new medicinal products in cardiovascular diseases. | Hjerte
> Hjertesvigt | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 10.000 | National | Regularly | 115057865983 |
| Approval of medicinal products by AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency]. | Respiratorisk
> Pulmonal hypertension | Regulatorisk partnerskab
> Arbejde med regulerende myndigheder | 100 | National | Rarely | 115060569246 |
| Meetings with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] and Agenas [Agenzia Nazionale per i Servizi Sanitari Regionali – National Agency for Regional Health Services]. | Nyre
> Nyresygdomme | Regulatorisk partnerskab
> Deltag i Health Technology Assessment (HTA) og refusionsgennemgange | 1.000 | Regional | Sometimes | 114997535217 |
| AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency], CNS [Consiglio Nazionale della Sanità - National Health Council], the Ministry, Parliament, the Regions, and regulatory bodies. | Immun
> Primære immundefekter | Regulatorisk partnerskab
> Deltag i Health Technology Assessment (HTA) og refusionsgennemgange | 10.000 | National | Regularly | 115020417471 |
| AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency]. | Kræft
> Kræft: bryst | Regulatorisk partnerskab
> Deltag i Health Technology Assessment (HTA) og refusionsgennemgange | We do not communicate with patients directly | National | Sometimes | 115035044046 |
| Letters were co-authored and submitted to AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] at the request of paediatric nephrologists, seeking compassionate use authorisation for investigational medicinal products. | Sjælden
> Sjældne sygdomme: nyre | Regulatorisk partnerskab
> Deltag i Health Technology Assessment (HTA) og refusionsgennemgange | 100 | National | Rarely | 115057369547 |
| The association represents patient interests before the institutions and regulatory authorities involved in decision-making processes relating to health policy, access to therapies, and the sustainability of the healthcare system. In particular, it promotes dialogue with regulatory bodies, healthcare institutions, and health system stakeholders with the aim of contributing to the development of policies that ensure equitable and appropriate access to treatments for people living with rheumatological conditions. This encompasses direct engagement with AIFA [Agenzia Italiana del Farmaco — the Italian Medicines Agency], as well as with regional authorities where dedicated regional working groups on rheumatological and rare rheumatological diseases have been established. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Regulatorisk partnerskab
> Deltag i Health Technology Assessment (HTA) og refusionsgennemgange | 100.000 | National | Regularly | 115057561938 |
| We are members of the EMA [European Medicines Agency] multi-stakeholder advisory board, and we are frequently invited to participate in the scientific advice committee for the approval of medicines for mitochondrial diseases. | Sjælden
> Sjældne sygdomme: genetisk | Regulatorisk partnerskab
> Bidrag til ansøgninger om markedsføringstilladelse | 100.000 | International | Regularly | 119078073632 |
| Our regional representatives participate in the regional diabetes technical working groups. | Endokrin
> Diabetes (både type 1 og type 2) | Regulatorisk partnerskab
> Involvering med organer for kliniske retningslinjer | 10.000 | National | No | 115028521635 |
| We requested meetings with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] on two occasions; one such request, in 2023, was successful. | Kræft
> Kræft: galdegang | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 100.000 | National | Rarely | 114996625156 |
| Meetings with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] and Agenas [Agenzia Nazionale per i Servizi Sanitari Regionali – National Agency for Regional Health Services]. | Nyre
> Nyresygdomme | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 1.000 | Regional | Sometimes | 114997535217 |
| We request meetings with regional authorities and hospital management bodies responsible for pharmaceutical distribution. | Blødning
> Blødningsforstyrrelser: de fleste typer | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 100 | Regional | Sometimes | 114997584898 |
| Through meetings with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] to safeguard the continued availability of medicines. | Sjælden
> Cystisk fibrose | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 10.000 | National | Regularly | 115005109524 |
| Through the Ministry of Health and the Lombardy Region. | HIV
> HIV | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 1.000 | Local | Regularly | 115006694528 |
| AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency], CNS [Consiglio Nazionale della Sanità - National Health Council], the Ministry, Parliament, the Regions, and regulatory bodies. | Immun
> Primære immundefekter | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 10.000 | National | Regularly | 115020417471 |
| We engage in dialogue with the Regional Authority and with the ASP [Aziende Sanitarie Provinciali – Provincial Health Authorities]. | Blødning
> Hæmofili | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 100 | Regional | Regularly | 115037242647 |
| Participation in public consultations of AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency], regional diabetes working groups, and contributions on access to CGM [Continuous Glucose Monitoring sensors sensors], insulin pumps, and innovative medicines. | Endokrin
> Diabetes (både type 1 og type 2) | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 100 | Local | Sometimes | 115037371533 |
| Audit and relationship with Italian regulatory AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency]. | Neurologisk
> Multipel sklerose | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 100.000 | National | Regularly | 115038849633 |
| Through submissions to AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] via the Technical Health Committee of the Ministry of Health. | HIV
> HIV | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 1.000 | National | Regularly | 115050875230 |
| The organisation represents patients before national and European regulatory bodies, including AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] and EMA [European Medicines Agency]. | Sjælden
> Sjældne sygdomme: metaboliske/lysosomale | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 1.000 | National | Regularly | 115050896715 |
| The association represents patient interests before the institutions and regulatory authorities involved in decision-making processes relating to health policy, access to therapies, and the sustainability of the healthcare system. In particular, it promotes dialogue with regulatory bodies, healthcare institutions, and health system stakeholders with the aim of contributing to the development of policies that ensure equitable and appropriate access to treatments for people living with rheumatological conditions. This encompasses direct engagement with AIFA [Agenzia Italiana del Farmaco — the Italian Medicines Agency], as well as with regional authorities where dedicated regional working groups on rheumatological and rare rheumatological diseases have been established. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 100.000 | National | Regularly | 115057561938 |
| The organisation [in Italy] actively engaged in challenging the withdrawal of a marketing authorisation for a medicinal product. It contributed to the submission of formal representations to the European Commission urging reconsideration of the withdrawal. | Sjælden
> Sjældne sygdomme: Lever | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 100 | National | Rarely | 115057832320 |
| AISC [Associazione Italiana Scompensati Cardiaci – Italian Association of Heart Failure Patients] maintains frequent engagement with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] and with national and regional decision-makers regarding the introduction and adoption of new medicinal products in cardiovascular diseases. | Hjerte
> Hjertesvigt | Regulatorisk partnerskab
> Deltag i/faciliter møder med politiske beslutningstagere/regulatorer | 10.000 | National | Regularly | 115057865983 |
| We collaborate with other patient associations of a similar nature to advocate for the approval and release of medicines required for our condition. | Kræft
> Kræft: blod | Regulatorisk partnerskab
> Med andre sundhedsforkæmpere | 1.000 | National | Rarely | 115006753491 |
| Through the UNIAMO [Unione Italiana delle Associazioni di Malati – Italian Federation of Rare Disease Patient Organisations] Federation, with which we are affiliated. | Sjælden
> Sjældne sygdomme: de fleste typer | Regulatorisk partnerskab
> Med andre sundhedsforkæmpere | 100 | National | Regularly | 115055436186 |
| Through a network of associations. | Kræft
> Kræft: de fleste typer | Regulatorisk partnerskab
> Med andre sundhedsforkæmpere | 100 | National | Regularly | 115057092350 |
| We are actively campaigning for the amendment or abolition of Nota 99 [Nota 99 is the Italian Medicines Agency (AIFA) reimbursement guideline for Chronic Obstructive Pulmonary Disease (COPD) maintenance therapies. It regulates the prescription of inhalers, ensuring appropriate diagnosis through spirometry while detailing which treatments GPs can initiate or repeat]. We are also campaigning for vaccination against Respiratory Syncytial Virus (RSV). | Respiratorisk
> Astma og KOL | Indflydelse på politik og lovgivning
> Påvirk sundhedspolitik og lovgivning | 5.000 | National | Regularly | 114996865765 |
| Active participation in the drafting and approval of legislation in support of the disease area. | Generelt helbred
> Fedme | Indflydelse på politik og lovgivning
> Påvirk sundhedspolitik og lovgivning | 10.000 | National | Regularly | 115012927513 |
| Cardiovascular Alliance — Ministry of Health. | Kardiovaskulær
> Kardiovaskulær: de fleste typer | Indflydelse på politik og lovgivning
> Påvirk sundhedspolitik og lovgivning | 100 | Regional | Sometimes | 115028352096 |
| By participating in regional and national policy-setting forums on rare diseases and skeletal dysplasia conditions more broadly. | Knogle
> Knogle: andet | Indflydelse på politik og lovgivning
> Påvirk sundhedspolitik og lovgivning | 100 | National | Regularly | 115037246562 |
| Yes. The association represents patients' interests before the institutions and regulatory authorities involved in decision-making processes related to healthcare policy, access to therapies, and the sustainability of the healthcare system. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Indflydelse på politik og lovgivning
> Påvirk sundhedspolitik og lovgivning | 100.000 | National | Regularly | 115057561938 |
| By participating in regional and national policy-setting forums on rare diseases and skeletal dysplasia conditions more broadly. | Knogle
> Knogle: andet | Indflydelse på politik og lovgivning
> Deltag i offentlige høringer og konsultationer | 100 | National | Regularly | 115037246562 |
| Participation in public consultations of AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency], regional diabetes working groups, and contributions on access to CGM [Continuous Glucose Monitoring sensors sensors], insulin pumps, and innovative medicines. | Endokrin
> Diabetes (både type 1 og type 2) | Indflydelse på politik og lovgivning
> Deltag i offentlige høringer og konsultationer | 100 | Local | Sometimes | 115037371533 |
| Audit and relationship with Italian regulatory AIFA [Agenzia Italiana del Farmaco - Italian Medicines Agency]. Relationship with regional health authorities. Reference clinical care pathways. Relationship with Ministries (Health, Welfare, Disability). | Neurologisk
> Multipel sklerose | Indflydelse på politik og lovgivning
> Mobiliser parlamentarikere og politiske ledere | 100.000 | National | Regularly | 115038849633 |
| Cross-Party Parliamentary Group — IVT [Intravitreal Therapy] Technical Working Group. Cataract Technical Working Group — Regional Partnerships — Local Activities. | Synshandicap
> Synshandicap | Indflydelse på politik og lovgivning
> Mobiliser parlamentarikere og politiske ledere | 1.000 | National | Regularly | 115056238448 |
| Active participation in the drafting and approval of legislation in support of the disease area. | Generelt helbred
> Fedme | Indflydelse på politik og lovgivning
> Bidrage til udarbejdelsen af folkesundhedslovgivning | 10.000 | National | Regularly | 115012927513 |
| AISC [Associazione Italiana Scompensati Cardiaci – Italian Association of Heart Failure Patients] maintains frequent engagement with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] and with national and regional decision-makers regarding the introduction and adoption of new medicinal products in cardiovascular diseases. | Hjerte
> Hjertesvigt | Indflydelse på politik og lovgivning
> Håndtering af barrierer/anomalier i medicinsk behandling | 10.000 | National | Regularly | 115057865983 |
| Market authorisation for "Koselugo" [used to treat neurofibromatosis type 1 (NF1)] should be extended to adult patients, given that it is currently approved only for paediatric cases where surgery is not an option. | Neurologisk
> Neurofibromatose (NF) | Indflydelse på politik og lovgivning
> Håndtering af barrierer/anomalier i medicinsk behandling | 1.000 | National | Sometimes | 115060431887 |
| Organisation of educational camps, disease prevention, regulatory-compliant monitoring [in Italy], and waiting list management. | Ikke angivet
> Ikke angivet | Prisfastsættelse og overkommelighed
> Sporing og overvågning af lægemiddelpriser/lægemiddelmangler | 100 | Local | Regularly | 115037563159 |
| Specifically at the level of the regional health authority, we have engaged in advocacy for the extension of the prescribability of Baqsimi (nasal glucagon) to be also reimbursable for adult diabetic patients. | Endokrin
> Diabetes (både type 1 og type 2) | Prisfastsættelse og overkommelighed
> Fortalelse af optagelse af produktet på refusionslister/nationale formularer | 1.000 | Local | Sometimes | 115023236354 |
| Participation in public consultations of AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency], regional diabetes working groups, and contributions on access to CGM [Continuous Glucose Monitoring sensors sensors], insulin pumps, and innovative medicines. | Endokrin
> Diabetes (både type 1 og type 2) | Prisfastsættelse og overkommelighed
> Fortalelse af optagelse af produktet på refusionslister/nationale formularer | 100 | Local | Sometimes | 115037371533 |
| Our work focuses on securing reimbursement for medicines, not on pricing. | Neurodegenerativ
> Demens | Prisfastsættelse og overkommelighed
> Fortalelse af optagelse af produktet på refusionslister/nationale formularer | 100.000 | National | Rarely | 115060441597 |
| Organisation of educational camps, disease prevention, regulatory-compliant monitoring [in Italy], and waiting list management. | Ikke angivet
> Ikke angivet | Prisfastsættelse og overkommelighed
> Deltage i oplysningskampagner | 100 | Local | Regularly | 115037563159 |
| Competitive tender for diabetes medical devices and supplies. | Endokrin
> Diabetes (både type 1 og type 2) | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 1.000 | Regional | Rarely | 114997517950 |
| We request meetings with regional authorities and hospital management bodies responsible for pharmaceutical distribution. | Blødning
> Blødningsforstyrrelser: de fleste typer | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 100 | Regional | Sometimes | 114997584898 |
| Through meetings with AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] to safeguard the continued availability of medicines. | Sjælden
> Cystisk fibrose | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 10.000 | National | Regularly | 115005109524 |
| We collaborate with other patient associations of a similar nature to advocate for the approval and release of medicines required for our condition [blood cancers]. | Kræft
> Kræft: blod | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 1.000 | National | Rarely | 115006753491 |
| Extension of the indications for the use of Baqsimi, indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged one year and above with diabetes mellitus. | Endokrin
> Diabetes (både type 1 og type 2) | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 1.000 | Regional | Sometimes | 115021346889 |
| At the regional health authority level in particular, advocacy efforts were undertaken to extend the prescribability of Baqsimi (nasal glucagon) to include reimbursement for adult patients with diabetes. Additionally, participation in the competitive tendering process for diabetes medical devices and supplies — including reagent test strips, continuous glucose monitoring sensors, and insulin pumps — was pursued. | Endokrin
> Diabetes (både type 1 og type 2) | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 1.000 | Local | Sometimes | 115023236354 |
| At the regional health authority level in particular, advocacy efforts were undertaken to extend the prescribability of Baqsimi (nasal glucagon) to include reimbursement for adult patients with diabetes. Additionally, participation in the competitive tendering process for diabetes medical devices and supplies — including reagent test strips, continuous glucose monitoring sensors, and insulin pumps — was pursued. | Endokrin
> Diabetes (både type 1 og type 2) | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 1.000 | Local | Sometimes | 115023236354 |
| The association is at the forefront of efforts to ensure that all patients receive the appropriate therapy and that treatment is applied consistently at the national level. | Synshandicap
> Neuromyelitis optica | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 100 | National | Regularly | 115024933081 |
| Meetings with FG [Focus Group] to improve community-based diabetology services. | Endokrin
> Diabetes (både type 1 og type 2) | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 100 | Local | Sometimes | 115032223368 |
| We are seeking early access for the drug vorasidenib [oral cancer therapy for people with gliomas]. | Kræft
> Kræft: hjerne | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 100 | National | Sometimes | 115050882510 |
| Formal request letters to expedite access to medicines. | Kræft
> Cancer: gynækologisk | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 1.000 | National | Sometimes | 115055638865 |
| The association represents patient interests before the institutions and regulatory authorities involved in decision-making processes relating to health policy, access to therapies, and the sustainability of the healthcare system. In particular, it promotes dialogue with regulatory bodies, healthcare institutions, and health system stakeholders with the aim of contributing to the development of policies that ensure equitable and appropriate access to treatments for people living with rheumatological conditions. This encompasses direct engagement with AIFA [Agenzia Italiana del Farmaco — the Italian Medicines Agency], as well as with regional authorities where dedicated regional working groups on rheumatological and rare rheumatological diseases have been established. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 100.000 | National | Regularly | 115057561938 |
| AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] or regional health authorities regarding delays in the market access of medicines. | Kræft
> Cancer: gynækologisk | Forbedring af adgangsveje
> Fremme retfærdig adgang til medicin/sundhedspleje | 1.000 | National | Rarely | 115060470442 |
| We are campaigning for vaccination against Respiratory Syncytial Virus (RSV) [in Italy]. | Respiratorisk
> Astma og KOL | Forbedring af adgangsveje
> Fortaler for bredere vaccinationsadgang | 5.000 | National | Regularly | 114996865765 |
| Specifically at the level of the regional health authority, we have engaged in advocacy for the extension of the prescribability of Baqsimi (nasal glucagon) to be also reimbursable for adult diabetic patients. | Endokrin
> Diabetes (både type 1 og type 2) | Forbedring af adgangsveje
> Håndter uligheder i adgang og administration | 1.000 | Local | Sometimes | 115023236354 |
| The association is at the forefront of efforts to ensure that all patients receive the appropriate therapy and that treatment is applied consistently at the national level. | Synshandicap
> Neuromyelitis optica | Forbedring af adgangsveje
> Håndter uligheder i adgang og administration | 100 | National | Regularly | 115024933081 |
| We are an integral part of the Innovative Medicines Group of the Veneto Region [part of Veneto Region's governance structure for evaluating and managing access to innovative medicines]. | Kræft
> Kræft: blod | Forbedring af adgangsveje
> Håndter uligheder i adgang og administration | 1.000 | National | Regularly | 115053421236 |
| Regional disparities in access to treatment and enrolment in therapeutic management plans. | Neurologisk
> Epilepsi | Forbedring af adgangsveje
> Håndter uligheder i adgang og administration | 1.000 | Regional | Sometimes | 115063172483 |
| By participating in regional and national policy-setting forums on rare diseases and skeletal dysplasia conditions more broadly. | Knogle
> Knogle: andet | Forbedring af adgangsveje
> Forbedring af adgangen til sjældne/ultrasjældne behandlinger | 100 | National | Regularly | 115037246562 |
| Letters were co-authored and submitted to AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency] at the request of paediatric nephrologists, seeking compassionate use authorisation for investigational medicinal products [for rare kidney conditions]. | Sjælden
> Sjældne sygdomme: nyre | Forbedring af adgangsveje
> Forbedring af adgangen til sjældne/ultrasjældne behandlinger | 100 | National | Rarely | 115057369547 |
| The organisation [in Italy] actively engaged in challenging the withdrawal of a marketing authorisation for a medicinal product. It contributed to the submission of formal representations to the European Commission urging reconsideration of the withdrawal. | Sjælden
> Sjældne sygdomme: Lever | Diagnose og medicinlevering
> Sikr sikker og effektiv medicinbrug | 100 | National | Rarely | 115057832320 |
| Our regional representatives participate in the regional diabetes technical working groups. | Endokrin
> Diabetes (både type 1 og type 2) | Diagnose og medicinlevering
> Deltag i udvikling af kliniske retningslinjer | 10.000 | National | No | 115028521635 |
| Audit and relationship with Italian regulatory AIFA [Agenzia Italiana del Farmaco - Italian Medicines Agency]. Relationship with regional health authorities. Reference clinical care pathways. | Neurologisk
> Multipel sklerose | Diagnose og medicinlevering
> Deltag i udvikling af kliniske retningslinjer | 100.000 | National | Regularly | 115038849633 |
| By participating in the regional coordination body that sits on the regional working table. | Endokrin
> Diabetes (både type 1 og type 2) | Institutionel styring
> Sikre repræsentation i statslige rådgivende organer | 100 | Regional | Rarely | 115019671886 |
| Regional health councillors, prescribing physicians, hospital pharmacists, regional drug directors, and representation at regional stakeholder forums. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Institutionel styring
> Sikre repræsentation i statslige rådgivende organer | 100.000 | National | Regularly | 115031446886 |
| We collaborate with institutional decision-makers, policymakers, and clinicians within a technical working group. | Endokrin
> Diabetes (både type 1 og type 2) | Institutionel styring
> Sikre repræsentation i statslige rådgivende organer | 100 | Local | Regularly | 115037426004 |
| We maintain regular contact with the relevant offices of the Tuscany Regional Authority. | Blødning
> Hæmofili | Institutionel styring
> Sikre repræsentation i statslige rådgivende organer | 100 | Regional | Regularly | 115043798242 |
| Represent patients before national and European regulatory bodies — including AIFA [Agenzia Italiana del Farmaco, the Italian Medicines Agency] and EMA [European Medicines Agency] — as well as national health institutions and local authorities. | Sjælden
> Sjældne sygdomme: metaboliske/lysosomale | Institutionel styring
> Sikre repræsentation i statslige rådgivende organer | 1.000 | National | Regularly | 115050896715 |
| In an advisory capacity, when consulted by the local and regional health authority (Azienda Sanitaria Locale). | Endokrin
> Diabetes (både type 1 og type 2) | Institutionel styring
> Sikre repræsentation i statslige rådgivende organer | 100 | Local | Rarely | 115060756578 |
| We are members of the EMA [European Medicines Agency] multi-stakeholder advisory board, and we are frequently invited to participate in the scientific advice committee for the approval of medicines for mitochondrial diseases. | Sjælden
> Sjældne sygdomme: genetisk | Institutionel styring
> Sikre repræsentation i statslige rådgivende organer | 100.000 | International | Regularly | 119078073632 |
| By participating in the regional coordination body that sits on the regional working table. | Endokrin
> Diabetes (både type 1 og type 2) | Institutionel styring
> Effektivt arbejde i netværk med flere interessenter | 100 | Regional | Rarely | 115019671886 |
| Participated alongside Public Institutions in the Stroke Observatory. | Cerebrovaskulær
> Streg | Institutionel styring
> Effektivt arbejde i netværk med flere interessenter | 5.000 | National | Regularly | 115019690819 |
| Participated alongside Public Institutions in the Stroke Observatory. | Cerebrovaskulær
> Streg | Institutionel styring
> Effektivt arbejde i netværk med flere interessenter | 5.000 | National | Regularly | 115019690819 |
| Regional health councillors, prescribing physicians, hospital pharmacists, regional drug directors, and representation at regional stakeholder forums. | Reumatisk
> Reumatiske sygdomme: de fleste typer | Institutionel styring
> Effektivt arbejde i netværk med flere interessenter | 100.000 | National | Regularly | 115031446886 |
| Participation in public consultations of AIFA [Agenzia Italiana del Farmaco – Italian Medicines Agency], regional diabetes working groups, and contributions on access to CGM [Continuous Glucose Monitoring sensors sensors], insulin pumps, and innovative medicines. | Endokrin
> Diabetes (både type 1 og type 2) | Institutionel styring
> Effektivt arbejde i netværk med flere interessenter | 100 | Local | Sometimes | 115037371533 |
| We collaborate with institutional decision-makers, policymakers, and clinicians within a technical working group. | Endokrin
> Diabetes (både type 1 og type 2) | Institutionel styring
> Effektivt arbejde i netværk med flere interessenter | 100 | Local | Regularly | 115037426004 |
| Audit and relationship with Italian regulatory AIFA [Agenzia Italiana del Farmaco - Italian Medicines Agency]. Relationship with regional health authorities. Reference clinical care pathways. Relationship with Ministries (Health, Welfare, Disability). | Neurologisk
> Multipel sklerose | Institutionel styring
> Effektivt arbejde i netværk med flere interessenter | 100.000 | National | Regularly | 115038849633 |
| Healthcare protection, consumer protection, and other related areas. | Generelt helbred
> Levering af sundhedsydelser | Opretholdelse af patientrettigheder/forbedring af livskvalitet
> Beskyttelse/forbedring af patientoplevelsen | 1.000 | Regional | Regularly | 115038525050 |
| Documentation requirements for the renewal of driving licences for individuals with diabetes. | Endokrin
> Diabetes (både type 1 og type 2) | Opretholdelse af patientrettigheder/forbedring af livskvalitet
> Beskyttelse/forbedring af patientoplevelsen | Do not know | Regional | Sometimes | 115046244188 |