Results 1 to 10 of about 3,266 (173)

Risk of plan management of the Chinese economy [PDF]

open access: yesEkonomski Signali, 2023
Based on official PRC statistics and analytical data obtained from modern scientific and public research, it follows that the so-called Chinese economic miracle has ended.
Skoropad Vladimir
doaj   +1 more source

Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system

open access: yesHuman Vaccines & Immunotherapeutics, 2022
Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages.
Miguel Betancourt-Cravioto   +4 more
doaj   +1 more source

Methodological Approaches to Risk Management of Advanced Therapy Medicinal Products

open access: yesРазработка и регистрация лекарственных средств, 2023
Introduction. Advanced therapy medicinal products (ATMPs) rely on recent advances in medical science, but alongside with potential benefits they may also bring safety concerns for patients. The inherent complexity of the ATMP production and use calls for
A. A. Taube, N. Yu. Velts
doaj   +1 more source

Risk Management Plan: An Expert Analysis of Changes to the EAEU Good Pharmacovigilance Practice Requirements for the Content and Submission of the Document

open access: yesБезопасность и риск фармакотерапии, 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.
T. M. Bukatina, E. V. Shubnikova
doaj   +1 more source

Analysis of Errors Identified during Regulatory Review of Risk Management Plans Submitted as Part of Registration Dossiers

open access: yesБезопасность и риск фармакотерапии, 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.
A. O. Lovkova   +3 more
doaj   +1 more source

Risk Management in Museums in Czech Republic

open access: yesChemical Engineering Transactions, 2020
Risk management in museums of the Czech Republic is inadequate and is not implemented in most museums. The presented issue of risk management in museums is only the first step towards introducing this knowledge into museums.
Marek Tomastik   +3 more
doaj   +1 more source

Critical Overview of the Contents of Risk Management Plans for Medicines

open access: yesБезопасность и риск фармакотерапии, 2022
The pharmacovigilance system plays one of the key roles in ensuring safety and efficacy of medicine use. The risk management process helps to ensure the most favourable benefit/risk ratio of a medicine or combination of medicines both for the target ...
T. M. Bukatina, E. V. Shubnikova
doaj   +1 more source

Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post‐approval in Japan

open access: yesPharmacology Research & Perspectives, 2023
Recently, post‐marketing safety measures have been considered critical in Japan due to the globalization of drug development and the introduction of new drug approval systems.
Rieko Saito, Seiko Miyazaki
doaj   +1 more source

Compliance with risk management plan recommendations on laboratory monitoring of antitumor necrosis factor-α therapy in clinical practice

open access: yesJournal of the Formosan Medical Association, 2016
A risk management plan (RMP) was introduced to monitor the association between initiation of antitumor necrosis factor-α (anti-TNF-α) therapy and tuberculosis (TB) and viral hepatitis infections.
Meng-Ju Chan   +6 more
doaj   +1 more source

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