hpra compassionate use - SERP Analysis

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

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

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

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

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

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

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.fda.gov/news-events/expanded-access/expanded-access-information-industry

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

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

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

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

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

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

https://in2pharma.com/new-policy-for-compassionate-use-programs/

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

https://www.lexology.com/library/detail.aspx?g=263cf9d6-e6fc-42ab-890d-dc9cd628787c

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

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

https://everyone.org/guides/country?code=IE

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

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

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

https://pci.com/wp-content/uploads/2020/05/PCI-European-Compassionate-Use-Programs.pdf

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

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

https://pubmed.ncbi.nlm.nih.gov/36605403/

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

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

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

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

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

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

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

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

https://www.statnews.com/2018/06/05/right-to-try-compassionate-use-pharma-compliance/

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

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

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

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

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

https://www.linkedin.com/pulse/life-science-leader-article-new-approaches-support-use-ray-m-d-?trk=articles_directory

https://eco-cdn.iqpc.com/eco/files/event_content/emaps-content-piece_39jiUfAd2H3o97RtBIqaM1WVgkk07f1NQOV0M7Tc.pdf

https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-003879-12/IE

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

https://trial-in.com/glossary/compassionate-use-early-access-program-named-patient-program-2/

https://www.escardio.org/static-file/Escardio/Advocacy/Initiatives/Cardiovascular%20Round%20Table/Documents/Plenary%20meeting%20Devices%2017-18%20April%202024%20Slides/Gearo%CC%81id%20McGauran.pdf

https://www.researchgate.net/publication/376017704_Efficacy_and_safety_of_compassionate_use_for_rare_diseases_a_scoping_review_from_1991_to_2022

https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.01604/pdf

https://www.drugsandalcohol.ie/30718/

https://cancercommons.org/latest-insights/encouraging-and-paying-for-clinical-trials-right-to-try-and-expanded-access-part-three/

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

https://www.bfarm.de/EN/Home/_node.html

https://static.jnjinnovativemedicine.com/91/e7/bad039c64865a9d7dfa3a475725e/j-j-paa-exanded-access-guide-june-2024.pdf

https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams

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

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

https://www.epilepsy.ie/sites/www.epilepsy.ie/files/HPRA%20-%20Cannabis%20for%20medical%20use.pdf

https://hrb.newsweaver.ie/drugnet/em12rymkws9?a=1&p=52233202&t=29019325

https://www.ms-society.ie/sites/default/files/2019-06/MS%20Ireland%20-%20Process%20for%20Licensing%20and%20Reimbursement%20of%20New%20Medications.pdf

https://www.insideeulifesciences.com/page/16/

https://www.researchgate.net/publication/353228999_The_Economic_Impact_of_Compassionate_Use_of_Medicines

https://www.pharmaceuticalonline.com/doc/fda-s-compassionate-use-gets-simpler-what-will-this-mean-for-drug-manufacturers-0001

https://www.thejournal.ie/temple-street-hpra-springs-6175491-Sep2023/

https://www.drugsandalcohol.ie/26061/1/hpra-annual-report-2015.pdf

https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-003881-32/IE

https://www.nrecoffice.ie/preparing-for-new-eu-clinical-trials-regulation-in-partnership-with-the-hpra/

https://www.williamfry.com/knowledge/regulatory-flexibility-key-measures-to-support-availability-of-medicines-and-medical-devices-during-covid-19/

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

https://www.ncpe.ie/for-patients/glossary-of-terms/

https://www.fagg.be/sites/default/files/QnA_repurposing_pilot_project_0.pdf

https://www.drugs.ie/news/article/minister_harris_publishes_milestone_report_on_cannabis_for_medical_use

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://www.irishexaminer.com/news/arid-20444059.html

https://www.ddregpharma.com/what-is-compassionate-use

https://gov.ie/en/department-of-health/press-releases/minister-for-health-announces-provision-for-the-delivery-and-funding-of-the-medicinal-cannabis-access-programme/

https://health.ec.europa.eu/document/download/085634a9-817d-4f6a-88f2-194ba5f3561e_en?filename=mp_swd_2024_49_en.pdf

https://www.hiqa.ie/sites/default/files/2023-11/HIQA-TOR-CHI-Review.pdf

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

https://www.cqc.org.uk/sites/default/files/20150716_safer_management_controlled_drugs_annual_report_2014.pdf

https://www.irishexaminer.com/news/arid-30776453.html

https://www.rezoomo.com/contentFiles/jobs/47452/attachments/28425_47452%20Senior%20Pharmacist%20%20Job%20Description%20April%202023.pdf

https://www.aurorahealthcare.org/rspp-irb/downloads/research-forms/compassionate-use

https://www.gmp-compliance.org/gmp-news/irelands-hpra-guide-for-sponsors-of-clinical-trials

https://everyone.org/zeposia-ozanimod

https://ie.linkedin.com/in/cecilia-gomes-0192a2100

https://www.rcsi.com/dublin/about/faculty-of-nursing-and-midwifery/education/overseas-aptitude-test/preparation

https://www.gsk.com/en-gb/locations/ireland/

https://akumin.com/

https://www.fda.gov/international-programs/confidentiality-commitments/ireland-health-products-regulatory-authority-hpra-fda-confidentiality-commitment

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

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

https://assets.hpra.ie/data/docs/default-source/corporate/consultations/public-consultation-proposed-fees-for-2025-human-medicines-compliance-activities-blood-tissue-establishments-organs-an.pdf?sfvrsn=d5287b19_5

https://assets.hpra.ie/data/docs/default-source/external-guidance-document/fin-g0002-guide-to-fees-for-human-products-v35.pdf?sfvrsn=dd51febb_23

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

https://assets.hpra.ie/data/docs/default-source/corporate/consultations/public-consultation-proposed-fees-for-2024-human-medicines-compliance-activities-blood-tissue-establishments-organs-an.pdf?sfvrsn=98fddaf0_5

https://assets.hpra.ie/data/docs/default-source/corporate/annual-reports/hpra-annual-report-2023.pdf?sfvrsn=1baa79f8_28