The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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The Guidelines for the Diagnosis, Treatment and Prevention of Leprosy provide state-of-the-art knowledge and evidence on leprosy diagnosis, treatment and prevention based on a public health approach in endemic countries. The target audience of this document includes policy-makers in leprosy or infec...tious diseases in the ministries of health (especially but not limited to endemic countries), nongovernmental organizations, clinicians, pharmaceutical companies, donors and affected persons
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The purpose of this guideline is to explain to healthcare professionals and administrative employees what their records management obligations are in terms of the National Archives and Records Service of South Africa
Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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These guidelines for the National Pharmacovigilance and Medicine Information System in Rwanda have been developed to ensure that safe, efficacious and quality medicines are made available to all Rwandans.
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.
Confronted with the important issue of patient safety, in 2002 the Fifty-fifth World Health Assembly adopted a resolution urging countries to pay the closest possible attention to the problem and to strengthen safety and monitoring systems. In May 2004, the Fifty-seventh World Health Assembly approv...ed the creation of an international alliance as a global initiative to improve patient safety. The World Alliance for Patient Safety was launched in October 2004 and currently has its place in the WHO Patient Safety programme included in the Information, Evidence and Research Cluster.
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This guideline is for:
• health and care practitioners
• health and care staff involved in planning and delivering services
• commissioners.
The recommendations bring together:
• existing national and international guidance and policies
• advice from specialists working in the NHS fr...om across the UK. These include people with
expertise and experience of treating patients for the specific health conditions covered by the
guidance during the current COVID-19 pandemic.
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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Glaucoma is a leading cause of irreversible blindness globally. In Malawi, glaucoma accounts for 15.8% of the blindness among people aged 50 years and above. Blindness from glaucoma is preventable with early detection and timely treatment. However, glaucoma management remains a challenge to eye care... providers due to its asymptomatic progression.
These guidelines inform eye care providers about the requirements for early detection of glaucoma, and the appropriate assessment and management of glaucoma patients. The guidelines also demonstrate the need for ophthalmologists to work with secondary-level eye care providers. With
glaucoma being a permanently blinding condition, it is vital to ensure that all eye care providers are adequately equipped with skills and resources for the early detection and management of glaucoma.
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