Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
WHO position paper on malaria vaccines, Weekly Epidemiological Record 10 May 2024
Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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Today, patient harm due to unsafe care is a large and growing global public health challenge and is one of the
leading causes of death and disability worldwide. Most of this patient harm is avoidable. As countries strive to
achieve universal health coverage and the Sustainable Development Goals, t...he beneficial effects of improved
access to health services can be undermined by unsafe care. Patient safety incidents can cause death and
disability, and suffering for victims and their families. The financial and economic costs of safety lapses are high.
There is often reduced public confidence and trust in local health systems when such incidents are publicized.
Health workers involved in serious incidents involving death or serious harm to a patient can also suffer lasting
psychological harm and deep-seated feelings of guilt and self-criticism.
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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an operational guide to support all those responsible for planning and implementing the rollout of COVID-19 vaccine to refugees and migrants at national and local levels, 14 March 2022
10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto...r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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orientations provisoires, première publication le 25 janvier 2021, mise à jour le 15 juin 2021, mise à jour le 19 novembre 2021
The position papers are intended for use by national public health officials and managers of immunization programmes. They may also be of interest to international funding agencies, vaccine advisory groups, vaccine manufacturers, health professionals, researchers, the scientific media and the genera...l public.
Les notes de synthèse s’adressent aux responsables nationaux de la santé publique et aux administrateurs des programmes de vaccination, mais elles peuvent également présenter un intérêt pour les organismes internationaux de financement, les groupes consultatifs sur la vaccination, les fabricants de vaccins, les professionnels de la santé, les chercheurs, les médias scientifiques et le grand public.
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The Access to COVID-19 Tools (ACT) Accelerator’s Country Readiness and Delivery workstream has released guidance on developing a national deployment and vaccination plan (NDVP) for COVID-19 vaccines. This course is intended to help national and sub-national focal points in countries develop the ND...VP and prepare for COVID-19 vaccine introduction.
Available in English and Macedonian
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This drill package is part of a broader COVID-19 simulation exercise package, including vaccine tabletop exercises(TTX). For exercises to be most effective, it is recommended they should be part of a comprehensive programme made up of progressively complex exercises, each exercise ... building on the previous one until they are as close to reality as possible
Available in English, Arabic, Chinese, French, Russian, Spanish and Portuguese
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Overview
16 Dec 2021. This interim guidance pertains to heterologous primary and heterologous boosting schedules of Covid-19 vaccines. It focuses on heterologous schedules combining multiple vaccine platforms (e.g. a vectored vaccine followed by an mRNA vaccine).
The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the use of placebo controls and unblinding of trial participants in current and future COVID-19 vaccine trials. This... policy brief was developed by the WHO Access to COVID-19 Tools (ACT) Accelerator Ethics & Governance Working Group, to provide guidance for researchers, sponsors, regulators, research ethics committees, and policy-makers, on these and related issues.
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Rivercess, Liberia, April 25, 2024 - Liberia marks a monumental milestone in its battle against malaria
as it launches the highly anticipated RTS,S malaria vaccine today, coinciding with World Malaria Day,
commemorated under the theme: Health Equity, Gender, and Human Rights: Accelerating the Figh...t
Against Malaria for a More Equitable World. The launch ceremony, held in Rivercess County, signals a
significant step forward in the nation's commitment to safeguarding the health of its children and
communities.
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This informational guide presents six strategies for immunization coordinators.
It includes tangible actions to promote confidence, communication, and uptake of COVID-19 vaccine, which can help support confidence among providers and patients.
The purpose of this Standard Operating Procedure (SOP) is to describe the detailed process on how to manage discarded COVID-19 vaccine vials and associated waste after COVID-19 vaccination activities end. The SOP provides clear instructions on how to perform the appropriate treatment and safe dispos...al of these wastes to minimize any associated health risk with consideration to local context.
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