Jul 5, 2020 06:56
3 yrs ago
20 viewers *
English term
12+ years of experience
Native in: Russian 
Works in: Russian to English, English to Russian
EPITT
English to Russian
Medical
Medical: Pharmaceuticals
PRAC PSUR assessment repo
Long-term Follow-up
A post-authorisation long-term retrospective safety cohort study of arsenic trioxide (Trisenox®) in first line low-to-intermediate risk acute promyelocytic leukaemia (APL) patients is planned and the protocol is currently under discussion by EMA.
The study will be aiming to assess the long-term safety of ATRA+ATO in newly diagnosed low to intermediate risk APL patients in a real-world clinical practice setting.
Rapporteur assessment comment:
This PASS remains expected.
To be noted, On 09 jun 2017, an EPITT signal was raised regarding this expected PASS with the following EPITT scope:
“Submission of a protocol for a post-authorisation long term safety cohort study in acute promyelocytic leukaemia (APL) patients treated with Trisenox to assess the long-term safety of all-trans retinoic acid (ATRA) + arsenic trioxide (ATO) in newly diagnosed low to intermediate risk APL patients in a real-worcheck ld clinical practice setting as requested in the conclusions of variation II/0058 finalised in October 2016”
A post-authorisation long-term retrospective safety cohort study of arsenic trioxide (Trisenox®) in first line low-to-intermediate risk acute promyelocytic leukaemia (APL) patients is planned and the protocol is currently under discussion by EMA.
The study will be aiming to assess the long-term safety of ATRA+ATO in newly diagnosed low to intermediate risk APL patients in a real-world clinical practice setting.
Rapporteur assessment comment:
This PASS remains expected.
To be noted, On 09 jun 2017, an EPITT signal was raised regarding this expected PASS with the following EPITT scope:
“Submission of a protocol for a post-authorisation long term safety cohort study in acute promyelocytic leukaemia (APL) patients treated with Trisenox to assess the long-term safety of all-trans retinoic acid (ATRA) + arsenic trioxide (ATO) in newly diagnosed low to intermediate risk APL patients in a real-worcheck ld clinical practice setting as requested in the conclusions of variation II/0058 finalised in October 2016”
Proposed translations
(Russian)
| 3 | Европейская система отслеживания проблем в сфере фармаконадзора |
Evgeni Kushch
|
Proposed translations
54 mins
Evgeni Kushch
Ukraine
Ukraine
Native in Russian
Specializes in field
Ukraine
MD with 12+ years in medical translation
Native in: Russian (Variant: Standard-Russia) , Ukrainian (Variant: Standard-Ukraine)
Works in: English to Russian, English to Ukrainian, Russian to English, and 3 more.
Related KudoZ points
:
1735
Selected
Европейская система отслеживания проблем в сфере фармаконадзора
EPITT: European Pharmacovigilance Issues Tracking Tool. A database developed by the EMA to promote the rapid communication of pharmacovigilance and risk management issues between the EMA, all National Competent Authorities (NCAs) of the European Economic Area (EEA), the Committee for Medicinal Products for Human use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human [CMD(h)] and (Co-) Rapporteurs.
«Средство», «инструмент» мне как-то не звучат. По определению можно и «база данных», возможно, написать.
«Средство», «инструмент» мне как-то не звучат. По определению можно и «база данных», возможно, написать.
4 KudoZ points awarded for this answer.
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