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 objective of this document is to guide the preparation and implementation of national preparedness plans for the safety of substances of human origin during outbreaks of Zika virus infection, both in affected and non-affected areas.
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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Clinician Outreach and Communication Activity (COCA) Call
April 12, 2016
WHO recommends that pre-exposure prophylaxis (PrEP) be offered as an additional prevention choice for HIV-negative individuals at substantial risk of HIV infection as part of combination prevention approaches.
HIV drug resistance has been rarely reported among PrEP users who tested HIV positive i...n randomized controlled trials or open-label studies. However, PrEP-selected HIV drug resistance could potentially negatively impact the effectiveness of treatment options among PrEP users who acquire HIV, since there is a potential for overlapping resistance profiles between antiretroviral drugs used for both PrEP and first-line antiretroviral therapy.
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Cervical cancer, along with maternal deaths, has been identified as a national priority in
South Africa as well as other Sub-Saharan African countries. Cervical cancer is the
second most common cancer among women in South Africa, after breast cancer. Due
to limited access to prevention, early dia...gnosis and treatment, cervical cancer is often
fatal.
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Para la elaboración de este documento, el grupo de farmacovigilancia de la Red Panamericana para la Armonización Farmacéutica (PARF) se basó en la perspectiva de la OPS/OMS, que considera que la farmacovigilancia es un componente esencial de los programas d...e salud pública (3). Se trabajó con la intención de facilitar el desarrollo de sistemas de farmacovigilancia en las Américas, así como su mejoramiento y fortalecimiento, y promover la
adopción de buenas prácticas para aumentar la seguridad del paciente y de la población, de acuerdo con las necesidades de la región.
Este documento también está disponible en Inglés y Portugués.
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Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production and inadequate waste disposal in the production of antimicrobials in China and I...ndia, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
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The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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