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Medicines Agencies schedule in the CIS countries due to COVID-19 pandemic
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
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
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
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.
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.
Roszdravnadzor sent letters to medical organizations about the organization of pharmacovigilance work, including criteria for auditing the pharmacovigilance system. These…
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In July 2020, new ICH guidelines should come into force
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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Training event “Management and operation of pharmacovigilance system in EAEU
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
The Government of the Russian Federation has approved the plan of transition of federal executive bodies to the implementation of…
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Criteria for assigning software to medical devices
The Commission of the Federal State Budgetary Institution “VNIIMT” of Roszdravnadzor for issuing conclusions on requests related to the circulation…
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