The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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The object of this bill is to provide for a legal framework to promote the existence of Community Health Workers (CHWs) and to provide for clarity in the role and responsibilities assigned to CHWs in the Health sector and to promote and strengthen service delivery at the Community level. ... The law will regulate training, certification and registration and set minimum qualifications and standards and working conditions for the CHWs.
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Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
Guidelines for the registration of microbial, botanical and semiochemical pest control agents for plant protection and public health uses.
These guidelines are intended to guide pesticide regulatory authorities in the registration of microbial, botanical, and semiochemical pest control agents for p...lant protection and public health uses.
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(You need free registration to download the book)
Disasters and public health emergencies can stress health care systems to the breaking point and disrupt delivery of vital medical services. During such crises, hospitals and long-term care facilities may be without power; trained staff, ambulances,... medical supplies and beds could be in short supply; and alternate care facilities may need to be used. Planning for these situations is necessary to provide the best possible health care during a crisis and, if needed, equitably allocate scarce resources
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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A.55 Medicines and Related Substances Act, 2013 | No. 8 of 2013 | An Act to provide for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
The document introduces a simple classification, minimums standards and a registration form for Foreign Medical Teams (FMTs) that may provide surgical and trauma care arriving within the aftermath of a sudden onset disaster. These can serve as tools to improve the coordination of the foreign medical... team response, and be the reference for registration on arrival as well as a possible global registration mechanism similar to what exists for urban search and rescue teams
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More than 700 000 people lose their life to suicide every year. A core foundation of suicide prevention is the timely registration and regular monitoring of suicide and self-harm. Surveillance data can be used to show important progress towards reaching global targets, such as reducing the suicide r...ate by one third by 2030 as articulated in the UN SDGs and in the WHO Mental Health Action Plan 2013-2030. However, there are considerable discrepancies in the quality of data on suicide and self-harm globally. The aim of this training manual is to equip fieldworkers and supervisors with the skills to collect and manage data on suicide and self-harm in the community via key informants, health-care facilities and police records. In doing so, the value and overall goal is to strengthen the surveillance of suicide and self-harm in communities, particularly in LMICs and hard-to-reach communities where CRVS systems are weak or absent.
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Case Study. The surprising link between logging and healthcare in Indonesia. You can download the teaching material and the case study after filling in a free registration form.
his case study examines a connection between rainforest conservation and affordable healthcare access in communities surr...ounding Gunung Palung National Park (GPNP) in West Kalimantan, Indonesia. It recognizes that human and environmental wellbeing cannot be seen as separate from one another. Specifically, it explores how deforestation impacts human health and well-being, and how implementing co-beneficial solutions can improve human health while protecting natural ecosystems. Finally, this case study highlights the importance of collaboration to achieve planetary health, both within communities and within organizational teams.
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This policy document is to guide the Traditional, Complimentary and Alternative Medicine practices in Rwanda. The various elements examined under the policy include, legislation and regulatory control, registration, manufacture, procurement and supply management, rational use, quality assurance, co-...ordination, monitoring and evaluation of Traditional, Complementary and Alternative Medicine practices.
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The purpose of adding the books to the website of MCAI for download, is to make this life-saving, up-to-date information available to all who need it. Fill in a short registration field and you can download the pdf-files.
If you work in a hospital in a low income country - providing free care - y...ou are probably intitled to FREE copies of these books. MCAI will send them to you, all you have to do is to read our Flyer and fill in the request form.
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The Lancet, Early Online Publication, 11 July 2014
doi:10.1016/S0140-6736(14)60934-X
*Free registration is required to view this article
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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The Story of Cholera is seen as a great tool to promote basic hygiene practices and has been narrated in Arabic to be shown in these Settlements. It is seen as both a prevention measure against potential cholera outbreak and/or other type of diarrheal diseases. Tested on site it has received a great... welcome from the refugee community and is expected to have a major impact in the hygiene promotion response.
Download flashcards, video and mobile phone version at: http://globalhealthmedia.org/story-of-cholera/videos/registration/
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General tips:
1- Make sure to assign a staff member to be the focal point to support persons with disabilities in every location/project. (The focal point should know the evacuation procedures).
2- The focal point should coordinate the evacuation and support persons with disabilities in case of an... evacuation/emergency.
3- Communicate clearly verbally and through other communication channels who the focal point is and support options available.
4- Make sure persons with disabilities/older persons are prioritized during evacuation.
5- Always inform everyone about the availability of specific services -remember that not all disabilities are visible.
6- Don’t make assumptions about the needs and priorities of persons with disabilities - Always ask them.
7- Make sure persons with disabilities/older persons are regularly updated and informed about the situation using different communication methods.
8- Look at the place/environment and think about other barriers persons with disabilities might face and address them.
9- Make sure that persons with disabilities, older persons, and those with sever medical conditions are identified when registering new arrivals or when doing door-to-door registration.
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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