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Free scientific and practical webinar on pharmacovigilance issues
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Free scientific and practical webinar on pharmacovigilance issues

Елена Матвеева2021-11-13T19:32:50+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 issuesЕлена Матвеева2021-11-13T19:32:50+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

Елена Матвеева2021-11-13T19:27:39+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 / 0026Елена Матвеева2021-11-13T19:27:39+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

Елена Матвеева2021-11-13T19:25:34+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 mgЕлена Матвеева2021-11-13T19:25:34+03:00

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

Елена Матвеева2021-11-13T19:24:41+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-00000539-202012Елена Матвеева2021-11-13T19:24:41+03:00

Warfarin — anticoagulant-related nephropathy

Елена Матвеева2021-11-13T19:21:43+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 nephropathyЕлена Матвеева2021-11-13T19:21:43+03:00

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

Елена Матвеева2021-11-13T19:18:43+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)Елена Матвеева2021-11-13T19:18:43+03:00

PRACTICAL ASPECTS OF PHARMACOVIGILANCE IN THE EAEU. IV Scientific and Practical online Conference
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PRACTICAL ASPECTS OF PHARMACOVIGILANCE IN THE EAEU. IV Scientific and Practical online Conference

Елена Матвеева2021-11-09T20:19:49+03:00

Dear colleagues! We invite you on December 15, 2021 to the annual scientific and practical online conference on pharmacovigilance, organized by the Pirogov Russian National Research Medical University, an autonomous non-profit organization "National Scientific Center for Pharmacovigilance", with the support of the company "Aforum". Within the framework of the conference, it is planned to [...]

PRACTICAL ASPECTS OF PHARMACOVIGILANCE IN THE EAEU. IV Scientific and Practical online ConferenceЕлена Матвеева2021-11-09T20:19:49+03:00

5-fluorouracil (intravenous) — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000007-202012

Елена Матвеева2021-11-09T14:55:56+03:00

Taking into account the available data on risk (s) from the literature and spontaneous reports, including in some cases a close temporal relationship, positive challenge-response, and/or re-challenge, PRAC consider that - the relationship between 5-fluorouracil (IV) and cutaneous lupus erythematosus - the relationship between 5-fluorouracil (IV) and stress cardiomyopathy (takotsubo syndrome) - the relationship between [...]

5-fluorouracil (intravenous) — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000007-202012Елена Матвеева2021-11-09T14:55:56+03:00

Composition of a registration dossier

Елена Матвеева2021-11-09T14:35:44+03:00

Our company can perform:- preparation of drug samples for evaluation during state registration,- writing sections 2,4-2,7 of the registration dossier,- amending the already submitted documents,- advising on the preparation of the dossier,- if necessary, to finalize the documents.At the time of submitting an application for state authorization of a medicinal product to the Ministry of [...]

Composition of a registration dossierЕлена Матвеева2021-11-09T14:35:44+03:00

Kazakhstan has introduced the practice of inspection of medical devices prior to state registration

Елена Матвеева2021-11-08T17:20:17+03:00

Medical devices with a medium (e.g., sterile injectable medical devices), high (dental implants, stents), or very high (implantable pacemakers, absorbable suture material) potential risk of use are subject to inspection. The national regulatory agency inspects not only the functioning of the quality management system of medical devices but also evaluates the measures taken by the [...]

Kazakhstan has introduced the practice of inspection of medical devices prior to state registrationЕлена Матвеева2021-11-08T17:20:17+03:00