Glossary entry (derived from question below)
English term or phrase:
compassionate
Romanian translation:
(acces) extins / compasional
Added to glossary by
Mara Cojocaru
Apr 4 09:55
2 mos ago
20 viewers *
English term
compassionate
English to Romanian
Medical
Medical (general)
Access to radiation therapies is not the same across the EU Member States, especially in the development and pilot phases.
This applies to compassionate and faster access to research drugs, and access for small hospitals that may lack expertise and infrastructure.
This applies to compassionate and faster access to research drugs, and access for small hospitals that may lack expertise and infrastructure.
Proposed translations
(Romanian)
4 +2 | (acces) extins / compasional | Éva Krecht |
5 | de urgență/în circumstanțe excepționale | Cristina Ciublan |
References
compassionate use | Alina O. |
Proposed translations
+2
3 hrs
Selected
(acces) extins / compasional
„Contrary to common usage, the terms “emergency use” and “compassionate use” are not synonymous. Become aware of the specific, separate standards for emergency use and compassionate use/expanded use to avoid violating federal regulations and UCSF policy regarding the use of unapproved drugs, biologics and devices.
Different FDA regulations apply to the different types of test article use, and the terminology can be confusing. Use the following definitions: (...)
Emergency use
Use of an investigational drug, biological product, or medical device generally requires either an IND (for unapproved drugs and biologics) or an IDE (for unapproved devices). (...)
Expanded access
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product. A patient may be able to receive the product (when appropriate) through expanded access when enrollment in a clinical trial is not possible, e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials.”
https://irb.ucsf.edu/emergency-use-and-compassionate-use-exp...
„An unlicensed medicine is not available on the market and it can only be used in clinical studies or in a compassionate use/expanded access setting.”
https://toolbox.eupati.eu/resources/off-label-use/
„Compassionate Use
Method of providing an unlicensed medicine prior to final approval by a regulatory (competent) authority for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained for compassionate use of a medicine or therapy.”
https://toolbox.eupati.eu/glossary/compassionate-use/
„Un medicament neautorizat nu este disponibil pe piață și poate fi utilizat numai în studii clinice sau în situații de uz compasional/acces extins.”
https://toolbox.eupati.eu/resources/utilizarea-in-alte-modur...
„Uz compasional
Metodă de furnizare a unui medicament neaprobat, înainte de autorizarea finală a acestuia de către o autoritate (competentă) de reglementare a medicamentelor de uz uman. Această procedură este utilizată în cazul persoanelor foarte bolnave, care nu au alte opțiuni de tratament. În numeroase circumstanțe, este necesară obținerea unei aprobări separate pentru fiecare caz de uz compasional al unui medicament sau al unei terapii.Ć
https://toolbox.eupati.eu/glossary/uz-compasional/?lang=ro
„Acest program este conceput pentru a oferi acces compasional la cannabis în scopuri medicale acolo unde tratamentele convenționale au eșuat,”
https://ro.formulaswiss.com/blogs/știri-din-industrie/pasul-...
Uzul compasional – sau utilizarea compasională – înseamnă permisiunea acordată de autoritățile de reglementare în cazul unui medicament neautorizat (experimental) la un grup extins de pacienți care nu au opțiuni de tratament ...”
https://www.monitorulbt.ro/localbt/2020/05/24/moartea-asiste...
https://ro.wikipedia.org/wiki/Uz_compasional
Different FDA regulations apply to the different types of test article use, and the terminology can be confusing. Use the following definitions: (...)
Emergency use
Use of an investigational drug, biological product, or medical device generally requires either an IND (for unapproved drugs and biologics) or an IDE (for unapproved devices). (...)
Expanded access
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product. A patient may be able to receive the product (when appropriate) through expanded access when enrollment in a clinical trial is not possible, e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials.”
https://irb.ucsf.edu/emergency-use-and-compassionate-use-exp...
„An unlicensed medicine is not available on the market and it can only be used in clinical studies or in a compassionate use/expanded access setting.”
https://toolbox.eupati.eu/resources/off-label-use/
„Compassionate Use
Method of providing an unlicensed medicine prior to final approval by a regulatory (competent) authority for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained for compassionate use of a medicine or therapy.”
https://toolbox.eupati.eu/glossary/compassionate-use/
„Un medicament neautorizat nu este disponibil pe piață și poate fi utilizat numai în studii clinice sau în situații de uz compasional/acces extins.”
https://toolbox.eupati.eu/resources/utilizarea-in-alte-modur...
„Uz compasional
Metodă de furnizare a unui medicament neaprobat, înainte de autorizarea finală a acestuia de către o autoritate (competentă) de reglementare a medicamentelor de uz uman. Această procedură este utilizată în cazul persoanelor foarte bolnave, care nu au alte opțiuni de tratament. În numeroase circumstanțe, este necesară obținerea unei aprobări separate pentru fiecare caz de uz compasional al unui medicament sau al unei terapii.Ć
https://toolbox.eupati.eu/glossary/uz-compasional/?lang=ro
„Acest program este conceput pentru a oferi acces compasional la cannabis în scopuri medicale acolo unde tratamentele convenționale au eșuat,”
https://ro.formulaswiss.com/blogs/știri-din-industrie/pasul-...
Uzul compasional – sau utilizarea compasională – înseamnă permisiunea acordată de autoritățile de reglementare în cazul unui medicament neautorizat (experimental) la un grup extins de pacienți care nu au opțiuni de tratament ...”
https://www.monitorulbt.ro/localbt/2020/05/24/moartea-asiste...
https://ro.wikipedia.org/wiki/Uz_compasional
Note from asker:
Mulțumesc, așa am găsit și eu. https://eur-lex.europa.eu/RO/legal-content/summary/driving-patient-oriented-innovations-in-eu-health-systems.html |
4 KudoZ points awarded for this answer.
Comment: "Mulțumesc"
52 mins
de urgență/în circumstanțe excepționale
Note from asker:
mulțumesc! |
Reference comments
21 hrs
Reference:
compassionate use
https://eur-lex.europa.eu/legal-content/EN-RO/TXT/?from=EN&u...
folosire în tratamente de ultima instanță
folosire în tratamente de ultima instanță
Note from asker:
Mulțumesc. Este și aceasta o variantă. |
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