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La Fundación Junior Achievement Colombia, mejor conocida como Colombia Emprendedora se complace en
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The document outlines the history and current state of childcare in Japan. It traces the origins of kindergartens back to 1871 and daycare centers to 1890. Today, the formal childcare system includes kindergartens overseen by the Ministry of Education for children ages 3-5, and daycare centers overseen by the Ministry of Health and Welfare for children ages 0-5. Attendance in preschool education has increased over time and there is a trend toward more free public options. The underlying philosophy focuses on teaching children etiquette, independence, and confidence. Childcare workers require specific training and certificates.
Guide for elaboration of clinical study reports for biological product regist...
This document provides guidance on the minimum content and format required for clinical study reports submitted for biological product registration or post-registration changes. It outlines 20 sections that should be included, such as background on the study design, objectives, treatments, endpoints, results analyses, and conclusions. Adherence to this standard format will help ensure clinical reports contain all necessary information to support regulatory reviews.
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This executive decree modifies regulations regarding the health registration of biological and biotech products in Panama. It establishes new requirements for registering biotech products, including presenting clinical trial data, quality and manufacturing information, risk management programs, and certificates of analysis for each imported batch. Biotech products already registered must now present clinical trials within 60 days to maintain their registration. The decree aims to ensure the efficacy, safety and quality of biopharmaceuticals marketed in Panama.
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The document provides guidelines for the evaluation of similar biotherapeutic products (SBPs). It outlines key principles for licensing SBPs, which include:
1) Development of a SBP involves stepwise comparability exercises starting with quality comparisons to a reference biotherapeutic product (RBP), with demonstration of similarity a prerequisite for reduced non-clinical and clinical data requirements.
2) Licensing of a SBP is based on its demonstrated similarity to a suitable RBP in quality, non-clinical, and clinical parameters.
3) Comparability exercises include integrated quality, non-clinical and clinical studies to provide comparative data between the SBP and RBP. Differences require investigation and may necessitate additional data.
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Este documento resume los conceptos básicos de la cría de Pokémon, incluyendo la selección de padres, el uso de ítems de cría para heredar ciertos IVs, y la importancia de la naturaleza para maximizar los stats de un Pokémon. Explica que la cría comienza con la elección del Pokémon y sus movimientos Egg, además de los IVs y padres importantes, y que los ítems como Everstone ayudan a heredar ciertos stats de los padres a los huevos.
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Este documento presenta las normas y las instrucciones de un juego de mesa sobre la ciudad de Santiago. Los jugadores avanzan por casillas tirando un dado y respondiendo preguntas sobre lugares y hechos de la ciudad. El juego contiene 23 casillas con sitios emblemáticos de Santiago y 20 preguntas sobre su historia, cultura y símbolos.
Recommended
Presentación mujeres emprendedoras accenture 2016
La Fundación Junior Achievement Colombia, mejor conocida como Colombia Emprendedora se complace en
presentar a ustedes el programa Mujeres Emprendedoras, que se ejecutará gracias al patrocinio de Accenture
Ltda. y con la colaboración de la Fundación Ana Restrepo del Corral.
Curso de crianza pokemon
Este documento resume los conceptos básicos de la cría de Pokémon, incluyendo la selección de padres, el uso de ítems de cría para heredar ciertos IVs, y la importancia de la naturaleza para maximizar los stats de un Pokémon. Explica que la cría comienza con la elección del Pokémon y sus movimientos Egg, además de los IVs y padres importantes, y que los ítems como Everstone ayudan a heredar ciertos stats de los padres a los huevos.
Japanese
The document outlines the history and current state of childcare in Japan. It traces the origins of kindergartens back to 1871 and daycare centers to 1890. Today, the formal childcare system includes kindergartens overseen by the Ministry of Education for children ages 3-5, and daycare centers overseen by the Ministry of Health and Welfare for children ages 0-5. Attendance in preschool education has increased over time and there is a trend toward more free public options. The underlying philosophy focuses on teaching children etiquette, independence, and confidence. Childcare workers require specific training and certificates.
Guide for elaboration of clinical study reports for biological product regist...
This document provides guidance on the minimum content and format required for clinical study reports submitted for biological product registration or post-registration changes. It outlines 20 sections that should be included, such as background on the study design, objectives, treatments, endpoints, results analyses, and conclusions. Adherence to this standard format will help ensure clinical reports contain all necessary information to support regulatory reviews.
Panama rules
This executive decree modifies regulations regarding the health registration of biological and biotech products in Panama. It establishes new requirements for registering biotech products, including presenting clinical trial data, quality and manufacturing information, risk management programs, and certificates of analysis for each imported batch. Biotech products already registered must now present clinical trials within 60 days to maintain their registration. The decree aims to ensure the efficacy, safety and quality of biopharmaceuticals marketed in Panama.
Who
The document provides guidelines for the evaluation of similar biotherapeutic products (SBPs). It outlines key principles for licensing SBPs, which include:
1) Development of a SBP involves stepwise comparability exercises starting with quality comparisons to a reference biotherapeutic product (RBP), with demonstration of similarity a prerequisite for reduced non-clinical and clinical data requirements.
2) Licensing of a SBP is based on its demonstrated similarity to a suitable RBP in quality, non-clinical, and clinical parameters.
3) Comparability exercises include integrated quality, non-clinical and clinical studies to provide comparative data between the SBP and RBP. Differences require investigation and may necessitate additional data.
Curso de crianza
Este documento resume los conceptos básicos de la cría de Pokémon, incluyendo la selección de padres, el uso de ítems de cría para heredar ciertos IVs, y la importancia de la naturaleza para maximizar los stats de un Pokémon. Explica que la cría comienza con la elección del Pokémon y sus movimientos Egg, además de los IVs y padres importantes, y que los ítems como Everstone ayudan a heredar ciertos stats de los padres a los huevos.
El peregrino perdido 2
Este documento presenta las normas y las instrucciones de un juego de mesa sobre la ciudad de Santiago. Los jugadores avanzan por casillas tirando un dado y respondiendo preguntas sobre lugares y hechos de la ciudad. El juego contiene 23 casillas con sitios emblemáticos de Santiago y 20 preguntas sobre su historia, cultura y símbolos.
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Guide for conducting comparability exercise for biological product registration
This document provides guidance for conducting a comparability exercise between a proposed biological product (BP) and an authorized comparator biological product (CBP) for the purpose of biological product registration. It outlines the quality, stability, manufacturing process, and data requirements that must be evaluated and presented in a comparability study to demonstrate that the BP is similar to the CBP, upon which reduced nonclinical and clinical data can be relied. Key aspects that must be compared include quality attributes, samples from manufacturing process stages, stability under stress conditions, and data from multiple batches. Significant unjustified differences found would indicate the products are not similar.
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The document discusses a presentation about tourism in Guam. It outlines Guam's mission to build trust between the military and local residents through mutual respect and quality of life concerns. It provides background on Guam's history of developing tourism since 1952. Key facts are presented on Guam's hotel inventory, visitor demographics, and interest groups. A SWOT analysis identifies strengths like beaches and diving, but also weaknesses like infrastructure and attitudes. Opportunities include new Asian markets, but threats include rising costs and local activism. Main issues discussed are over-reliance on Japan, lack of identity, and low visitor retention.
Guide for conduction of nonclinical and clinical studies for registration of ...
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La lista presenta los estudiantes con excelencia académica en el primer trimestre. Algunos de los estudiantes destacados son María Gómez, quien obtuvo las mejores calificaciones en matemáticas, y Juan Pérez, que se destacó en ciencias.
Guide for conducting comparability exercise for biological product registration
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The document summarizes the history and development of kindergarten and daycare centers in Japan. It notes that the first kindergarten was established in 1876, and kindergarten became part of the basic school education system in 1947 under the Ministry of Education. The first daycare center opened in 1890, and they were set up in factories starting in 1894, receiving subsidies beginning in 1908 and becoming classified as child welfare facilities in 1947 under the Ministry of Health and Welfare. Attendance rates for preschool education increased over time, reaching 100% for 4-5 year olds by 1981. Public and private kindergartens and daycares receive different levels of financial support. A basic plan from 2008 aimed to increase
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Este documento contiene las respuestas de un estudiante a varias preguntas sobre una lectura. En resumen, el estudiante opina que la actitud de dependencia de los pájaros no es buena, ya que no tienen un rumbo definido. También dice que es importante definir metas y no depender de los demás. Finalmente, el estudiante explica que su rumbo es terminar sus estudios y cumplir sus sueños a través del trabajo duro.
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This document outlines a research project on using shared decision making (SDM) to guide discussions about biosimilars and biological agents in Latin America. The project will involve two stages: 1) an international survey to understand stakeholders' perspectives on SDM and its applicability to biosimilars, and 2) development and testing of a decision aid tool to facilitate SDM discussions on biosimilars while accounting for cultural factors. The goal is to explore barriers to SDM implementation and develop a validated decision aid to guide discussions and priority setting around biosimilar treatment options in Latin America.
Zipcar101
Zipcar is a global car sharing service that provides vehicles by the hour or day to both personal and business members. It has over 650,000 members and 9,000 vehicles worldwide. Zipcar allows businesses to save time, money, and hassle compared to owning vehicles or using taxis/rental cars. Employees can reserve vehicles online or via app for meetings, errands, client meetings, and other occasions. Zipcar is also environmentally friendly by taking personally owned vehicles off the road. Business memberships provide discounted hourly rates and other benefits.
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This document outlines regulations for controlling human pharmaceutical products in a national system. It establishes the Ministry of Health and the Institute of Public Health as the competent authorities responsible for regulating pharmaceutical activities including registration, manufacturing, distribution, and advertising. It also assigns responsibilities to Regional Health Departments for authorizing product admission and enforcing compliance. Finally, it provides definitions for 29 key terms related to pharmaceutical quality, safety, and regulation.
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This document outlines the development of an experimental enterprise called FoodLoop that tackles the urban food waste problem. The enterprise aims to get every housing estate in Britain composting food waste on site and using the compost to grow fruits and vegetables. It discusses the food waste problem, stakeholders involved, the service and system designed including food waste collection, composting, and growing food. It provides examples of other social enterprises and encourages participants to create their own enterprise idea that connects issues and fits their skills. The document promotes an approach of zooming in and out between specific problems and the bigger picture to develop solutions.
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The document discusses a presentation about tourism in Guam. It outlines Guam's mission to build trust between the military and local residents through mutual respect and quality of life concerns. It provides background on Guam's history of developing tourism since 1952. Key facts are presented on Guam's hotel inventory, visitor demographics, and interest groups. A SWOT analysis identifies strengths like beaches and diving, but also weaknesses like infrastructure and attitudes. Opportunities include new Asian markets, but threats include rising costs and local activism. Main issues discussed are over-reliance on Japan, lack of identity, and low visitor retention.
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Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
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Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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