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Author: admi nistrato

Medicines Agencies schedule in the CIS countries due to COVID-19 pandemic

31/03/2020 admi nistrato

Please, note the changes in the schedule of some Expert Centres: Ukraine – State Expert Centre of the Ministry of…

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Basic documents in the framework of PV in the EAEU. Practical peculiarities of PSUR preparation

27/03/2020 admi nistrato Leave a comment

Given the evolving situation with coronavirus (COVID-19), SmartPharma Group is forced to postpone the training сourse, сonsisting of 3 webinars…

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New Chairman of the EAEU Pharmacopoeia Committee

admi nistrato

Ardak Tulegenova, a new Chairman of the EAEU Pharmacopoeia Committee who was elected on March 18, 2020, announced the release…

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Basic documents in the framework of pharmacovigilance in the EAEU. Practical peculiarities of PSUR preparation

10/03/2020 admi nistrato Leave a comment

SmartPharma Group is delighted to invite you to participate  in a training сourse, сonsisting of 3 webinars and training workshop devoted…

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National Centre for Expertise of Medicines and Medical Devices of the Republic of Kazakhstan has indefinitely suspended production and quality assurance inspections from February 27, 2020.

04/03/2020 admi nistrato

The decision was made considering current situation with the spread of coronavirus in the world and will obviously impact marketing…

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An audit of pharmacovigilance in health facilities will cause increased reports of adverse reactions.

02/03/2020 admi nistrato

Roszdravnadzor sent letters  to medical organizations about the organization of pharmacovigilance work, including criteria for auditing the pharmacovigilance system. These…

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Filed under: auditing the pharmacovigilance system, pharmaceuticals registered, pharmacovigilance

In July 2020, new ICH guidelines should come into force

admi nistrato Leave a comment

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted 2 annexes to the guidelines…

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Filed under: annex ICH E9 (R1), Committee for Medicinal Products for Human Use, guidelines ICH S5 (R3), ICH EMA

Training event “Management and operation of pharmacovigilance system in EAEU

24/02/2020 admi nistrato Leave a comment

Training event “Management and operation of pharmacovigilance system in EAEU. Critical aspects” was held by SmartPharma Group, on the 20-21…

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A number of permits in the sphere of MP circulation will be available in electronic form

18/02/2020 admi nistrato Leave a comment

The Government of the Russian Federation has approved the plan of transition of federal executive bodies to the implementation of…

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Filed under: medical devices, medicinal products, permits for import, state registration

Criteria for assigning software to medical devices

17/02/2020 admi nistrato

The Commission of the Federal State Budgetary Institution “VNIIMT” of Roszdravnadzor for issuing conclusions on requests related to the circulation…

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Filed under: Criteria for assigning, medical devices, software

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