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Regulation of health technologies 52 (a) Why regulate medical products? 53 (b) Clinical trials 54 (c) Research ethics 54 (i) Clinical trial ethics 54 (ii) Health databases and biobanks 55 (iii) Bioethics 55 (d) Biotherapeutic products 56 (i) Background 56 (ii) Pathways for the registration of biotherapeutic products 56 (iii) What will be the effect of SBPs on prices? (...) Registration of clinical trials in pharmaceutical product development 148 c. overcoming market failures in medical product r&d 151 1. (...) Substandard and falsified (SF) medical products 214 (a) Types of SF medical products 214 (b) Counterfeit medical products and the TRIPS Agreement 215 (c) The impact of SF medicines 215 (d) How can SF medical products be combated?
Language:English
Score: 919456.7 - https://www.wto.org/english/re...ntents_who-wipo-wto_2020_e.pdf
Data Source: un
Scope The document covers reliance activities in the field of regulation of medical products (i.e. medicines, vaccines, blood and blood products and medical devices including in-vitro diagnostics), addressing all the regulatory functions in the full life cycle of a medical product, as defined in the Global Benchmarking Tool (5): registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight and NRA lot release. (...) The concept of reliance covers all types of medical products and regulatory activities. Reliance approaches should be given consideration in 242 W H O T ec hn ic al R ep or t S er ie s, N o. 1 03 3, 2 02 1 WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-fifth report particular for medical products for priority diseases for which there are unmet medical needs, medical products to be used in public health emergencies or during shortages and also for orphan and paediatric medical products. 4. (...) Work-sharing and joint activities are examples of mutual reliance. 5.3 Life cycle approach The concept of reliance for regulation of medical products should be applied throughout the life cycle of medical products and in all regulatory functions (see 3.
Language:English
Score: 919191.8 - https://www.wto.org/english/tr...chsymp_290621/gaspar_pres3.pdf
Data Source: un
Countries face a range of obstacles to achieving this, including rising prices for new medicines; shortages and stock outs of essential medicines, especially for noncommunicable diseases, and the growing problem of substandard and falsified medical products entering the global supply chain. (...) Browse   Our work All → Supporting the quality and safety of blood products Strengthening medical imaging Strengthening collaboration on Health Technology Assessment Strengthening access to essential medicines Standardizing biotherapeutic products Providing International biological reference preparations Providing guidance to countries on institutionalizing Health Technology Assessment Promoting rational use of medicines Promoting national medicines policies Prioritizing medical devices Technical information Access to assistive technology & medical devices INN and classification of medical products (INN) Medicines Selection, Intellectual Property and Affordability Technical Standards and specifications Local Production & Assistance Regulation and safety Expert committees The Global Advisory Committee on Vaccine Safety Q&A's The WHO Essential Medicines List Antibiotic Book The WHO Essential Medicines List Antibiotic Book Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Multimedia All → 21 December 2020 Getting vaccines, medicines and tests ready for emergency use 29 July 2020 Promoting Access and Medical Innovation Publications All → 5 September 2022 WHO Expert Committee on Biological Standardization. (...) Download Read More 30 July 2021 World Local Production Forum: Enhancing access to medicines and other health technologies The World Local Production Forum: Enhancing access to medicines and other health technologies (WLPF) brings the global community – foremost government...
Language:English
Score: 917867.2 - https://www.who.int/our-work/a...ry-committee-on-vaccine-safety
Data Source: un
Trade policy and the economics of global production systems are also key factors in strategic plans to build domestic production capacity that aim for better access to medical products. (...) As technology evolves, more combination products materialize – mainly in the area of medicines in medical devices delivery sets. (...) For example, regulation of medical products is an integral part of the access equation.
Language:English
Score: 917637.3 - https://www.wto.org/english/tr...web_e/ch1d_trilat_web_13_e.htm
Data Source: un
About us Home / Teams / Health products policy and standards / Assistive & Medical Technologies / Medical devices / < go back Local production Local production and technology transfer Appropriate, affordable and good quality medical devices are indispensable in healthcare services. They serve for the prevention, diagnosis and treatment of diseases.  Local production is essential to bridge inequity gaps in access to medical devices. (...) In the context of the Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property, the World Health Organization (WHO) with support from the European Union developed this two project reports on medical devices access through local production. 3 June 2016 Towards improving access to medical devices through local production phase II: report of a case study in four sub-Saharan countries Download Read More 22 January 2012 Local Production and Technology Transfer to Increase Access to Medical Devices -...
Language:English
Score: 917466.6 - https://www.who.int/teams/heal...dical-devices/local-production
Data Source: un
Countries face a range of obstacles to achieving this, including rising prices for new medicines; shortages and stock outs of essential medicines, especially for noncommunicable diseases, and the growing problem of substandard and falsified medical products entering the global supply chain. (...) Browse   Our work All → Supporting the quality and safety of blood products Strengthening medical imaging Strengthening collaboration on Health Technology Assessment Strengthening access to essential medicines Standardizing biotherapeutic products Providing International biological reference preparations Providing guidance to countries on institutionalizing Health Technology Assessment Promoting rational use of medicines Promoting national medicines policies Prioritizing medical devices Technical information Access to assistive technology & medical devices INN and classification of medical products (INN) Medicines Selection, Intellectual Property and Affordability Technical Standards and specifications Local Production & Assistance Regulation and safety Expert committees WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) The Global Advisory Committee on Vaccine Safety Advisory Group meeting on fair pricing Expert Committee on Selection and Use of Essential Medicines Expert Committee on Biological Standardization Expert Committee on Drug Dependence Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) Q&A's The WHO Essential Medicines List Antibiotic Book The WHO Essential Medicines List Antibiotic Book Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Multimedia All → 21 December 2020 Getting vaccines, medicines and tests ready for emergency use 29 July 2020 Promoting Access and Medical Innovation Publications All → 5 September 2022 WHO Expert Committee on Biological Standardization. (...) Download Read More 30 July 2021 World Local Production Forum: Enhancing access to medicines and other health technologies The World Local Production Forum: Enhancing access to medicines and other health technologies (WLPF) brings the global community – foremost government...
Language:English
Score: 916482.7 - https://www.who.int/our-work/a...-medicines-and-health-products
Data Source: un
The GBT is designed to benchmark the regulatory programmes of a variety of product types, including medicines, vaccines, blood products (including whole blood, blood component and plasma derived products) and medical devices (including in vitro diagnostics).  This is made possible by introducing supplemental criteria to a common set of criteria initially developed for medicines and vaccines in order to accommodate the specificities of blood products and medical devices e.g., hemovigilance for blood products; and risk-based classification/reclassification of medical devices. (...) All queries related to GBT should be sent to WHO Regulatory Systems Strengthening Team at  [email protected] 10 May 2021 WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products - Revision VI WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products - Revision VI 1 February 2021 Manual for benchmarking of the national regulatory system of medical products and formulation of institutional development plans Manual for benchmarking of the national regulatory system of medical products and formulation of institutional development plans Regulatory systems strengthening Regions Africa Americas Eastern Mediterranean Europe South-East Asia Western Pacific Policies Cyber security Ethics Permissions and licensing Preventing sexual exploitation Terms of use About us Careers Library Procurement Publications Frequently asked questions Contact us Subscribe to our newsletters Privacy Legal Notice © 2022 WHO
Language:English
Score: 915289.5 - https://www.who.int/tools/global-benchmarking-tools
Data Source: un
But even then, a general shortage of medical faculty exacerbates the problem. Increasing the capacity and productivity of the medical education system and ensuring it is developing highly competent medical professionals is essential to increasing the overall capacity of the healthcare system. (...) The only way to bridge the gap is to use ICT effectively to increase the productivity of medical schools.” – Dr. V. D. Patil, Dean, Jawaharlal Nehru Medical College in Belgaum 22 Working with partners in the industry (including Dell, HP, HCL, and Tata), the India Department of Education, the Medical Council of India, the Dental Council of India, and the Medical Education Research Centre for Education Technologies, Intel identi- fied an opportunity to design and build a comprehensive ICT solution, specifically for medical colleges, that could both improve the education received by medical students and increase the capacity of the colleges. (...) “Technology extends the product-ivity of faculty and allows medical schools to reach students in more efficient ways, such as self-paced and distance learning.”
Language:English
Score: 915018.7 - https://www.who.int/pmnch/medi...012/intel_worldahead_india.pdf
Data Source: un
Selected manufacturers and products must meet requirements that conform to international quality management system standards, norms, rules and regulations for medical devices. (...) Document 09/06/2022 Technical requirements for medical devices UNICEF's requirements for medical devices suppliers and products. Download file (PDF, 482,07 KB) Document 18/02/2016 Technical requirements in vitro diagnostics (IVD) UNICEF's requirements for in vitro diagnostics suppliers and products. Download file (PDF, 507,57 KB) Document 18/06/2019 Technical requirements for personal protective equipment UNICEF's rerquirements for personal protective equipment suppliers and products.
Language:English
Score: 914760.6 - https://www.unicef.org/supply/...-personal-protective-equipment
Data Source: un
Search Close Search UNICEF Fulltext search Max 0B792406-3C90-48E8-AF22-4D48618D699F Created with sketchtool. Search results Medical devices Document 09/06/2022 Technical requirements for medical devices UNICEF's requirements for medical devices suppliers and products. (...) Document 07/04/2020 Target Product Profile: Identification of Yellow Fever UNICEF is looking for point of care diagnostic tools to ensure accurate and early confirmation of yellow fever cases. (...) Page 28/06/2019 Technical standards and requirements Consult the international standards and regulatory frameworks that UNICEF applies to ensure the safety and quality of products for children. Document 18/06/2019 Technical requirements for personal protective equipment UNICEF's rerquirements for personal protective equipment suppliers and products.
Language:English
Score: 913494.2 - https://www.unicef.org/supply/topics/medical-devices
Data Source: un