National regulatory authorities (NRAs) are the gatekeepers of the supply chain of medical products, and they have a mandate to ensure the quality, safety and efficacy of medicines, vaccines, blood, and blood products, medical devices, including diagnostics and traditional, or herbal medicines. However, the majority of the world's regulators are still struggling to reach a level of maturity, whereby they have a stable, well-functioning and integrated regulatory system. The World Health Organization (WHO) has developed a Global Benchmarking Tool (GBT) as part of its five-step capacity building program to assist NRAs, using the tool, they can benchmark their own strengths and areas of weakness, and then engage in a formal benchmarking process together with WHO and international experts in order to formulate an effective and workable institutional development plan. The GBT is comprehensive across the entire product life cycle and allows benchmarking to be customized to the needs of the NRA. It has evolved from decades of experience using a variety of benchmarking tools, within WHO and other stakeholder organizations. By the end of December 2019, 26 countries had undergone formal benchmarking, and a further 54 countries had used the GBT to conduct self-benchmarking exercises assisted by WHO.
Some pathological observations on the naturally infected dromedary camels (Camelus dromedarius) with the Middle East respiratory syndrome coronavirus (MERS-CoV) in
Background: Regulatory preparedness for public health emergencies is critical. However, responses to past emergencies, such as the 2009 H1N1 influenza pandemic and medical product shortages, have revealed sizable gaps in countries' regulatory capacity and preparedness. A systematic analysis of the regulatory preparedness of countries around the world has not yet been performed. The purpose of this study was to analyze and document the current regulatory preparedness status, highlight the related gaps and challenges in order to propose strategic, harmonized, and sustainable regulatory solutions to improve future responses to public health emergencies.Methods: From 2016 to 2020, we used the World Health Organization (WHO)'s Global Benchmarking Tool (GBT), a standardized instrument for identifying national regulatory authorities' strengths and gaps, to analyze the regulatory preparedness of 84 Member States, 95% of which were low- or middle-income countries. We analyzed whether participating Member States had not implemented, displayed ongoing implementation, had partially implemented, or had fully implemented 10 of the GBT's 268 sub-indicators most relevant to regulatory preparedness for public health emergencies.Findings: Only 10 Member States (12%) that underwent benchmarking had fully implemented all 10 sub-indicators related to regulatory preparedness for public health emergencies; 34 (40%) had fully implemented ≥50% of the emergency sub-indicators, and 20 (24%) had not fully implemented any of the sub-indicators. With regard to individual sub-indicators, regulatory preparedness ranged from 19 Member States (23%) fully implementing reliance on clinical trial decisions of others to 45 (59%) fully implementing legal provisions to fast-track (or expedite) marketing authorization applications.Interpretation: Many WHO Member States have limited regulatory preparedness for a public health emergency. Strengthening regulatory systems and promoting Good Regulatory Practices and reliance in these countries, to enable efficient response to emergencies, should be a global health priority.
AIM:Midline anterior skull base meningiomas include olfactory groove meningiomas (OGMs), Tuberculum Sellae meningiomas (TSMs), and planum sphenoidale meningiomas (PSMs). The main surgical challenge in treating these lesions is to excise the tumor totally without causing mortality or morbidity. Studying the clinical patterns and the surgical outcomes of these lesions. MATErIAL and METHods:Thirty cases of midline anterior skull base lesions were included in our study. Patients were operated upon by four routes: (i) unilateral subfrontal, (ii) bilateral subfrontal, (iii) frontotemporal approach, and (iv) bifrontal basal interhemispheric. Extent of resection was classified according to the Simpson grading system. The functional outcome of the patients was assessed by comparing the preoperative and the postoperative neurological examination, as well as the Karnofsky performance scale. rEsuLTs:We had 14 OGMs (46.7%), 9 TSMs (30%), and 7 PSMs (23.3%). The most commonly utilized approach was the subfrontal approach (unilateral or bilateral) in 80% of the cases, followed by the pterional approach in 16.6% of the cases. Total removal was achieved in 86.7% of the cases; subtotal excision was achieved in 13.3% of the cases. 41.2% of our cases showed postoperative clinical improvement. We had two mortalities in our study, representing 6.7%. We did not detect any tumor recurrences in our follow up. The median preoperative Karnofsky scale was 85, while the median postoperative Karnofsky scale was 90.CoNCLusIoN: Midline anterior skull base lesions are becoming amenable for total surgical excision with minimal morbidities and mortalities. Most preferred surgical routes are the subfrontal and the pterional approaches.KEywords: Olfactory groove meningiomas, Planum sphenoidale meningiomas, Tuberculum sellae meningiomas, Simpson grade ÖZ AMAÇ: Orta hat anterior kafa kaidesinin menenjiyomları olfaktör oluk menenjiyomları (OOM'ler), tüberkulum sella menenjiyomları (TSM'ler) ve planum sfenoidale menenjiyomları (PSM'leri) içerir. Bu lezyonların tedavisindeki ana cerrahi zorluk tümörün herhangi bir mortalite veya morbiditeye neden olmadan tümüyle eksizyonudur. Bu lezyonların klinik paternleri ve cerrahi sonuçları çalışılmıştır. yÖNTEM ve GErEÇLEr: Çalışmaya otuz orta hat anterior kafa kaidesi lezyonu dahil edilmiştir. Hastalar dört yolla ameliyat edilmiştir: (i) ünilateral subfrontal, (ii) bilateral subfrontal, (iii) frontotemporal yaklaşım ve (iv) bifrontal bazal interhemisferik. Rezeksiyon kapsamı Simpson derecelendirme sistemine göre sınıflandırılmıştır. Hastaların işlevsel sonucu preoperatif ve postoperatif nörolojik muayenenin ve Karnofsky performans ölçeği sonuçlarının karşılaştırılmasıyla değerlendirilmiştir.BuLGuLAr: 14 OOM (%46,7), 9 TSM (%30) ve 7 PSM (%23,3) mevcuttur. En sık kullanılan yaklaşım, olguların %80'inde kullanılan subfrontal yaklaşım (unilateral veya bilateral) olmuş ve bunu olguların %16,6'sında pterional yaklaşım takip etmiştir. Total eksizyon olguların %86,7'sinde ve subtotal eksizyon %13,3'ünde elde ed...
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