About Елена Матвеева

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So far Елена Матвеева has created 886 blog entries.

Typology of problems in the Russian pharmacovigilance system

2021-11-13T20:03:11+03:00

The Russian pharmacovigilance system faces a spectrum of problems on its way to the formation, including fragmented formulation of conclusions and identification of polymorphic "targets" for subsequent adoption of appropriate management decisions in the field of pharmacovigilance. Typologization of existing problems in the field of pharmacovigilance is a method of reducing the variety of objects under study into several systematized groups for subsequent consolidated analysis of directions to optimize the mechanisms of this system and the possibilities of improving its effectiveness.

Typology of problems in the Russian pharmacovigilance system2021-11-13T20:03:11+03:00

FDA approves first drug to treat senile farsightedness

2021-11-13T19:45:33+03:00

Allergan has received FDA approval for the first therapy to treat senile hyperopia. The drug in the form of eye drops is safe and can significantly improve vision for up to six hours. Effective as soon as 15 minutes after application, these eye drops use a specialized formula that combines pilocarpine, a recognized eye therapeutic, [...]

FDA approves first drug to treat senile farsightedness2021-11-13T19:45:33+03:00

Free scientific and practical webinar on pharmacovigilance issues

2021-11-13T19:32:50+03:00

Dear colleagues! We invite you to participate in a free-of-charge scientific and practical webinar on pharmacovigilance, organized by the "National Scientific Center for Pharmacovigilance" on November 26, 2021. The webinar starts at 10.00. The webinar will address current issues: Conducting a monitoring of literary sources; Drug safety risk management; Development of the Pharmacovigilance System Master [...]

Free scientific and practical webinar on pharmacovigilance issues2021-11-13T19:32:50+03:00

Intravenous Iron preparation: CMDh Scientific Conclusions and Reasons for Deviations, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / J / 0026

2021-11-13T19:27:39+03:00

Based on PRAC's review of the final PASS Study Report Version 1.1, PRAC believes that the condition of the PASS to further characterize the safety concerns about hypersensitivity reactions with respect to the safe and effective use of intravenous iron-containing medications can be removed. data source and details

Intravenous Iron preparation: CMDh Scientific Conclusions and Reasons for Deviations, Amendments to Product Information and Implementation Schedule — EMEA / H / N / PSR / J / 00262021-11-13T19:27:39+03:00

Information letter No. 01I-1430/21 of 26.10.2021 on the introduction of new safety data in the instructions for use of the drug Nexium® (INN — Esomeprazole) 10 mg

2021-11-13T19:25:34+03:00

The following sections of the instructions for medical use of the drug have been amended; - "Side Effects." - The information has been updated. Information was added to subsection: "Skin and subcutaneous tissue disorders": acute generalized exanthematous pustulosis and drug rash with eosinophilia and systemic symptoms (DRESS syndrome) with an incidence of "very rare". data [...]

Information letter No. 01I-1430/21 of 26.10.2021 on the introduction of new safety data in the instructions for use of the drug Nexium® (INN — Esomeprazole) 10 mg2021-11-13T19:25:34+03:00

Carbamazepine — Scientific Findings and Basis for Modification of Registration Approval — PSUSA-00000539-202012

2021-11-13T19:24:41+03:00

PRAC proposes the following changes to the Smpc: Interaction with brivaracetam Hyperammonemia Use during pregnancy and in women of childbearing age data source and details

Carbamazepine — Scientific Findings and Basis for Modification of Registration Approval — PSUSA-00000539-2020122021-11-13T19:24:41+03:00

Warfarin — anticoagulant-related nephropathy

2021-11-13T19:21:43+03:00

PRAC analyzed pooled data from spontaneous case reports, clinical trials, and the literature regarding the risk of anticoagulant-associated nephropathy in patients receiving warfarin. PRAC has agreed that MAH of drugs containing warfarin should submit a change within 2 months of publication of the PRAC recommendation to change the product information - where applicable, the proposed [...]

Warfarin — anticoagulant-related nephropathy2021-11-13T19:21:43+03:00

Cefoperazone — Scientific Conclusions and Basis for Modification of Registration Approval Terms — PSUSA-00000597-202101 (Hematuria)

2021-11-13T19:18:43+03:00

In view of the available data on coagulopathy and bleeding from clinical trials, literature, spontaneous reports, and given a plausible mechanism of action, PRAC believes a causal relationship between cefoperazone and hematuria to be at least reasonably possible. PRAC concluded that information about products containing cefoperazone should be changed accordingly. data source and details

Cefoperazone — Scientific Conclusions and Basis for Modification of Registration Approval Terms — PSUSA-00000597-202101 (Hematuria)2021-11-13T19:18:43+03:00

Бесплатный научно-практический вебинар по вопросам фармаконадзора

2021-11-28T22:54:03+03:00

Уважаемые коллеги! Приглашаем Вас 26 ноября 2021 принять участие в бесплатном научно-практическом вебинаре по вопросам фармаконадзора, организатором которого является «Национальный научный центр Фармаконадзора». Начало вебинара в 10.00. В рамках вебинара будут рассмотрены актуальные вопросы: Проведение мониторинга литературных источников; Управление рисками применения лекарственных средств; Разработка Мастер-файла системы фармаконадзора; Особенности организации ПРИБ (пострегистрационных исследований безопасности лекарственных [...]

Бесплатный научно-практический вебинар по вопросам фармаконадзора2021-11-28T22:54:03+03:00

Цель Центра по фармаконадзору

Целью организации является развитие системы фармаконадзора, защита здоровья населения, мониторинг безопасности лекарственных средств, анализ, оценка риска использования лекарственных средств, медицинских изделий, развитие образования и науки в области фармаконадзора и безопасности лекарственных средств, а также содействие развитию системы фармаконадзора на территории Евразийского экономического союза.

КОНТАКТНАЯ ИНФОРМАЦИЯ

  • Российская Федерация. Москва. ул. Бауманская 6, стр. 2
  • 8-800-777-86-04

УСЛУГИ ПО ФАРМАКОНАДЗОРУ

Страница участника Сколково

АНО «Национальный научный центр Фармаконадзора» является резидентом инновационного фонда «Сколково» с 2018 года

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