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Month: March 2020

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

March 31, 2020 Valeriia zhelieva Leave a comment

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

March 27, 2020 Valeriia zhelieva 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

Valeriia zhelieva

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

March 10, 2020 Valeriia zhelieva 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.

March 4, 2020 Valeriia zhelieva

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.

March 2, 2020 Victoriia Onuchko

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

Victoriia Onuchko 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

Recent Posts

  • The Russian side opposed to postpone Implementation period of the EAEU Rules of marketing authorisation December 3, 2020
  • MedSafety app launch in the Kyrgyz Republic November 25, 2020
  • Important amendments to the EAEU legislative acts October 20, 2020

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