hpra compassionate use application - SERP Analysis

https://www.hpra.ie/regulation/medical-devices/common-aspects-of-the-regulations/compassionate-use-applications

https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0231-manufacturer-application-for-compassionate-use-of-a-non-ce-marked-medical-device-v3.docx?sfvrsn=afbc03ba_5

https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0170-consultant-application-for-compassionate-use-of-a-non-ce-marked-medical-device-or-ivd-v3.docx?sfvrsn=9830e666_5

https://www.hpra.ie/make-a-submission/medical-devices

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compassionate-use

https://www.hpra.ie/regulation/human-medicine/patients-and-healthcare-professionals/access-to-medicines-before-authorisation

https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry

https://www.gov.ie/en/department-of-health/press-releases/medical-cannabis-access-programme-launch-enables-compassionate-access-to-cannabis-for-medical-reasons/

https://pmc.ncbi.nlm.nih.gov/articles/PMC5116859/

https://www.pfizer.com/science/clinical-trials/expanded-access

https://www.appliedclinicaltrialsonline.com/view/technology-s-role-managing-compassionate-use-program

https://www.insideeulifesciences.com/2021/01/15/belgium-amends-compassionate-use-and-medical-need-program-rules-to-expand-access/

https://innovativemedicine.jnj.com/file/22951

https://www.lanternpharma.com/compassionate-use

https://www.wepclinical.com/what-is-a-compassionate-use-program/

https://www.hpra.ie/regulation/medical-devices/common-aspects-of-the-regulations

https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine.html

https://www.sciencedirect.com/science/article/pii/S2352320415000553

https://mytomorrows.com/blog/biopharma/expanded-access-program-compassionate-use-frameworks-europe/

https://www.clinigengroup.com/insight/insights/2016/preapproval-access-exploring-the-landscape-for-compassionate-use-expanded-access-right-to-try-and-how-companies-can-prepare-and-take-action/

https://www.sma-europe.eu/news/roche-announces-global-pre-approval-access-compassionate-use-paa-cu-plans-for-risdiplam

https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.1095860/full

https://ojrd.biomedcentral.com/articles/10.1186/s13023-023-02978-x

https://www.gmp-journal.com/current-articles/details/the-ideal-managed-access-compassionate-use-legislation.html

https://www.arthurcox.com/wp-content/uploads/2024/01/Life-Sciences-Regulation-in-Ireland-Overview.pdf

https://www.osborneclarke.com/system/files/documents/22/03/30/Compassionate%20use%20product%20OCI%20-%20March%202022%28114177089.4%29.pdf

https://www.southsoundcarefoundation.org/open-trials/expanded-access-trials

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-treatment-expanded-access-overview

https://corex-logistics.com/news/named-patient-program-vs-compassionate-use-program/

https://www.sciensus.com/knowledge-hub/compassionate-use-programs-in-europe-all-you-need-to-know/

https://jamanetwork.com/journals/jama-health-forum/fullarticle/2799530

https://telixpharma.com/wp-content/uploads/Policy-on-Offering-Compassionate-Use-to-Investigational-Medicines.pdf

https://innovativemedicine.jnj.com/how-we-work/pre-approval-access

https://www2.healthservice.hse.ie/documents/3348/HSENPSA_0022023_Supplementary_Information_Medical_Device_Regulation_P2xdhOF.pdf

https://www.pei.de/EN/regulation/clinical-trials/compassionate-use/compassionate-use-node.html

https://www.interceptpharma.com/our-research/pipeline/expanded-access/

https://pmc.ncbi.nlm.nih.gov/articles/PMC9810195/

https://www.wepclinical.com/when-is-compassionate-use-a-viable-treatment-option/

https://www.clinicalleader.com/doc/compassionate-use-program-cup-benefits-strategies-in-rare-disease-0001

https://catalystpharma.com/wp-content/uploads/2021/06/Compassionate_Use_Policy_Ver_2_Final_03_Mar_2021.pdf

https://www.mereobiopharma.com/media/ldaoglot/mereo-expanded-access-policy.pdf

https://nuvalent.com/expanded-access-policy/

https://www.arthurcox.com/wp-content/uploads/2020/04/007_IRELAND.pdf

https://jamanetwork.com/journals/jama-health-forum/fullarticle/2791197

https://www.fiercebiotech.com/cro/parexel-launches-end-to-end-compassionate-use-service

https://earlyaccesscare.com/news/compassionate-use-and-expanded-access-programs

https://www.linkedin.com/pulse/expanded-access-programs-101-why-so-many-names-cisiv-ltd

https://www.researchgate.net/publication/294733593_Compassionate_use_of_drugs_and_medical_devices_in_the_United_States_the_European_Union_and_Japan

https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.2641

https://www.pharmexec.com/view/compassionate-use-requests-complicate-drug-development

https://www.hpra.ie/regulation/medical-devices/medical-devices-regulation/what-is-a-drug-device-consultation

https://www.oireachtas.ie/en/debates/question/2020-11-10/676/

https://health.ec.europa.eu/document/download/511462ac-f888-43dc-a326-b7288a334cef_en?filename=stamp_stamp_agenda_point_4_es_aemps_en.pdf

https://www2.healthservice.hse.ie/organisation/nqpsd/pst/safety-alerts/medical-device-regulation-and-ce-marking/

https://www.clinicalleader.com/doc/the-key-differences-between-expanded-access-programs-and-investigator-sponsored-trials-0001

http://www.ipharminc.com/expanded-access-and-compassionate-use

https://www.biopharmadive.com/news/fda-simplifies-compassionate-use-process-in-a-big-way/361462/

https://telixpharma.com/wp-content/uploads/2023/12/BPOL-0045-Policy-on-Managed-Access-to-investigational-medicines_PUBLIC.pdf

https://www.sciencedirect.com/science/article/pii/S2452302X17302917

https://www.gmp-journal.com/current-articles/details/compassionate-use-and-other-managed-access-concepts.html

https://www.youtube.com/watch?v=xlWsi30pcj4

https://www.hpra.ie/regulation/human-medicine/marketing-authorisation-holders/guidance-documents

https://www.everycrsreport.com/reports/R44134.html

https://med.nyu.edu/departments-institutes/population-health/divisions-sections-centers/medical-ethics/research/working-group-compassionate-use-preapproval-access/frequently-asked-questions

https://arrowheadpharma.com/about/corporate-governance/compassionate-use/

https://www.hpra.ie/regulation/veterinary-medicines/medicines-authorisation/accessing-unauthorised-veterinary-medicines

https://www.jazzpharma.com/science/expanded-access

https://www.roche.com/innovation/process/clinical-trials/investigational-medicines

https://lumos-pharma.com/compassionate-use-policy/

https://pink.citeline.com/-/media/supporting-documents/pink-sheet/2023/02/p0223ire_4a.pdf

https://atyrpharma.com/patients/expanded-access-policy/

https://marinuspharma.com/managed-access-program-use/

https://www.matinasbiopharma.com/lnc-technology/mat2203-expanded-access-policy

https://www.ternspharma.com/expanded-access

https://www.mt-pharma-america.com/expanded-access-policy

https://catalystpharma.com/clinical-trials/

https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0067-guide-to-refusals-and-appeals-v7.pdf?sfvrsn=9ef39d75_7

https://www.pharmaceuticalcommerce.com/view/fda-streamlines-compassionate-use-process

https://www.ahpra.gov.au/

https://www.gilead.com/medicines/medication-access/managed-access

https://www.vetsurgeon.org/b/veterinary-news?pi3983=143&pifragment-7128=2&pifragment-7749=3

https://www.hpra.ie/regulation/medical-devices/common-aspects-of-the-regulations/certificates-of-free-sale

https://www.hpra.ie/regulation/human-medicine/patients-and-healthcare-professionals/clinical-trials

https://globalforum.diaglobal.org/issue/october-2022/patients-need-not-wait-evolving-compassionate-use-and-named-patient-programs-across-asia-pacific/

https://researchservices.georgetown.edu/irb-knowledge-center/compassionate-expanded-access-and-emergency-use-of-drugs-devices/

https://www.hpra.ie/regulation/human-medicine/marketing-authorisation-holders/new-applications

https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/compassionate-drug-use.html

https://assets.hpra.ie/data/docs/default-source/corporate/hpra-functions-matrix.pdf?sfvrsn=1c176d18_0

https://www.hpra.ie/regulation/human-medicine/patients-and-healthcare-professionals/generic---interchangeable-medicines

https://assets.hpra.ie/data/docs/default-source/external-guidance-document/fin-g0002-guide-to-fees-for-human-products-v35.pdf?sfvrsn=dd51febb_31

https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0067-guide-to-refusals-and-appeals-v7-changes-trackedab7adf1d-42e6-4cd3-8231-3c6193427ca5.pdf?sfvrsn=bf3583a5_3

https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0147-guide-to-electronic-submissions---medical-devices-v1.pdf?sfvrsn=dd85857c_5

https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0090-guide-to-the-notification-system-for-exempt-medicinal-products-v5.pdf?sfvrsn=cb8b4578_7

https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0170-guide-to-clinical-trials-conducted-under-the-ctr-in-ireland-v4.pdf?sfvrsn=acffec7d_9