Zobrazeno 1 - 10
of 166
pro vyhledávání: '"gvp"'
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 4, Pp 463-472 (2023)
Scientific relevance. On 6 December 2022, an updated version of the Rules for Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP) came into force. The greatest changes were made to the requirements for pharmacovigilance document
Externí odkaz:
https://doaj.org/article/e8004f3c093145b6b68709628882ed19
Autor:
B. K. Romanov
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 1, Pp 14-21 (2023)
By Decision No. 81 of 19.06.2022, the Council of the Eurasian Economic Commission amended the Guideline on Good Pharmacovigilance Practices of the Eurasian Economic Union (EAEU GVP Guideline), the core regulatory document on pharmacovigilance require
Externí odkaz:
https://doaj.org/article/6332103c831140b58981036a69fcd34b
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 1, Pp 22-29 (2023)
The development of international regulatory practices and the accumulation of new experience in pharmacovigilance prompted the need to amend the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline), first ado
Externí odkaz:
https://doaj.org/article/8685ecadd6b14595844ddc25f7bbee54
Autor:
T. M. Bukatina, E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 1, Pp 30-37 (2023)
The Council of the Eurasian Economic Commission published Decision No. 81 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” on 19 June 2022 and enacted it on 6 December 2022. A risk management plan (RM
Externí odkaz:
https://doaj.org/article/d4c7ef2297034442b9c3ec0d9c4a8568
Publikováno v:
Безопасность и риск фармакотерапии, Vol 0, Iss 4, Pp 23-28 (2022)
The article presents the results of a comparative analysis of Goodpharmacovigilance practices (GVP), developed by experts of the regulatory bodiesof the European Union (EU) and the United States. It is shown that the EU GVP cover almost all possible
Externí odkaz:
https://doaj.org/article/2e8d10becbd14d1ab34f58252937bf9f
Publikováno v:
Безопасность и риск фармакотерапии, Vol 10, Iss 1, Pp 13-18 (2022)
The inspection of pharmacovigilance systems is regulated by the Good Pharmacovigilance Practices (GVP) and local laws and regulations. Inspections may be carried out by audit teams of competent authorities as part of regulatory activities or business
Externí odkaz:
https://doaj.org/article/e95c45c62f6c44d9a551c2829bcd6bc2
Publikováno v:
Безопасность и риск фармакотерапии, Vol 9, Iss 4, Pp 185-190 (2021)
Since 1 January 2021 the authorisation of medicines in the Russian Federation has to be performed according to the Eurasian Economic Union (EAEU) procedure. The Pharmacovigilance System Master File (PSMF) is the main document describing the pharmacov
Externí odkaz:
https://doaj.org/article/024e9db267684f748cdb8e2cc3a7f0c5
Autor:
B. K. Romanov
Publikováno v:
Безопасность и риск фармакотерапии, Vol 9, Iss 3, Pp 111-116 (2021)
The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations. These inspection processes apply mainly to marketing authoris
Externí odkaz:
https://doaj.org/article/5c678024a5c7448f8eacc1753db9057d
Autor:
Tatiana I. Shashkova, Dmitriy Umerenkov, Mikhail Salnikov, Pavel V. Strashnov, Alina V. Konstantinova, Ivan Lebed, Dmitriy N. Shcherbinin, Marina N. Asatryan, Olga L. Kardymon, Nikita V. Ivanisenko
Publikováno v:
Frontiers in Immunology, Vol 13 (2022)
One of the primary tasks in vaccine design and development of immunotherapeutic drugs is to predict conformational B-cell epitopes corresponding to primary antibody binding sites within the antigen tertiary structure. To date, multiple approaches hav
Externí odkaz:
https://doaj.org/article/c3c8b83e19044717be83a4edba248e81
Publikováno v:
Безопасность и риск фармакотерапии, Vol 9, Iss 2, Pp 75-84 (2021)
Good pharmacovigilance practices (GVP) of the Eurasian Economic Union (EAEU) were prepared based on the GVP of the European Medicines Agency that have been in force in the European Union (EU) since 2012. The EAEU GVP have been in force in the Russian
Externí odkaz:
https://doaj.org/article/6f22f46453bd4c47bcd4283b7964942a