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Riera L.,National Center for the Breeding of Laboratory Animals | Sosa L.,National Center for the Breeding of Laboratory Animals | Fuentes D.,National Center for the Breeding of Laboratory Animals | Perez L.M.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | And 4 more authors.
Animal Technology and Welfare | Year: 2013

The procurement and breeding of experimental animals, their use, protection, welfare, microbiological categories and the establishment of ethical principles in experimentation, have been subjected to national and international regulations. In order to establish and standardise technical specifications related to these aspects, the Guide to Good Practice for the care, use and reproduction of experimental animals (BPCURAL) was developed. This document can be used as a national reference for verifying the per formance of good clinical and non-clinical practice and the activity of the Institutional Committees for the Care and Use of Laboratory Animals (IACUC) respecting to facilities, maintenance, care and use of animals, as well as, for the training and qualification of the related staff. The BPCURAL guide contains the following headings: Introduction, Definitions and Concepts, Reach and Responsibilities, Basic, Specific and Ethical Principles in animal experimentation, Institutional Programmes for the care, use and breeding of laboratory animals and bibliographic and reference annexes. This guide as a manual is par t of the quality management system for these experimental bio-models, allowing per formance of these tasks in the animal facility, vivariums and institutions that use animals in experiments. It meets what is established in the regulations, standards and national and international codes, making it applicable to all staff and structures, which because of their work, are directly or indirectly linked to the per formance of tasks for the breeding and use of experimental animals. Also, it will harmonise the principles and criteria used in the national system of experimental animals in Cuba, favouring the transparency in the process of inspections and accreditations.

Frias-Ferreiro G.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | Ysa-Sanchez A.M.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | Garcia-Gutierrez B.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | Garcia-Garcia V.,Oficina Territorial de Normalizacion OTN
Revista de Calidad Asistencial | Year: 2010

The aim of this paper is to illustrate the social impact of drugs regulatory authorities' procedures, viewed from the perspective of the implementation of a quality management system. A review of drug regulations and their influence on quality and health systems is described. © 2009 SECA.

Gonzalez A.M.G.,Escuela Nacional de Salud Publica | Farinas A.G.,Escuela Nacional de Salud Publica | Sanchez C.P.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed
Revista Cubana de Educacion Medica Superior | Year: 2011

The research lines of the masteŕs degree studies in health economics are designed pursuant to the research priorities of this field of knowledge, hence they can be taken as reference of the scientific production on this subject nationwide. The most addressed topics are the restructuring of the medical assistance in the national health care system, the economic evaluation of health technologies and the pharmacoeconomics. Most of the theses are drafted in primary health care institutions. The research work nationwide are frequent, being the majority of them tutored by multidisciplinary teams in which professionals from the medical, health and economic sciences jointly work. Over 80% of these tutors are PhD in specific specialties. The objective of the present paper was to describe the scientific production of the Master's degree studies in health economics based on the theses submitted at the National School of Public health from 2003 to 2010. It underlined the significance of the masteŕs degree theses as research works and their analysis as a means of approaching to the evolution of scientific research in this sphere.

The Department of Vaccines and Biologics in the World Health Organization has developed an evaluation tool to identify the condition of the regulatory functions and the training of drug regulatory authorities to comply with their functions. This article was intended to provide the drug regulatory agencies from the non-developed countries with the necessary training, so that they can successfully perform their basic function in giving authorization to clinical trials with vaccines. Literature from WHO, the International Conference of Harmonization, the European Union, the Council of the International Organization of Medical Sciences, the US Food and Drug Administration and other regulatory documents of interest was reviewed. Data related to those indicators evaluating the performance of the drug regulatory authorities in giving permission for clinical trials with vaccines were collected and the five indicators assessing the contents and function of these authorities, their characteristics and relevant aspects were described. Furthermore, a summary of the essential aspects of the clinical trials with vaccines according to the WHO guideline as well as the experience of the Cuban regulatory authority in authorizing the conduction of these clinical trials was provided. The Drug Regulatory Authority is the responsible for assuring that vaccines for human beings meet the regulatory requirements of the country in the first place, and then for the research, commercialization or introduction of the vaccine in the National Immunization Program.

Hechavarria Nunez Y.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | Perez Massipe R.O.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | Orta Hernandez S.D.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | Munoz L.M.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | And 4 more authors.
Biologicals | Year: 2011

Biopharmaceuticals make up a significant proportion of medicinal products used for the treatment of diseases such as cancer, arthritis, cardiac dysfunctions and AIDS. Access to therapies based on the use of these products has been limited as a result of the high marketing costs. Cuba has a biopharmaceutical industry with great potential for innovation, capable of developing new products and to produce others, like the biosimilars destined to fulfill the needs of its National Health System. The Center for State Control on the Quality of Drugs (CECMED) the Cuban NRA, is facing the challenge of regulating the approval of biosimilar products manufactured locally. Consequently, CECMED has issued a position paper establishing the basic principles for regulation of these products and a specific guideline on this was elaborated. © 2011.

Batista Albuerne N.,Hospital Clinico Quirurgico Hermanos Ameijeiras | Soriano Garcia J.L.,Hospital Clinico Quirurgico Hermanos Ameijeiras | Collazo Herrera M.,Centro Para El Control Estatal Of La Calidad Of Los Medicamentos Cecmed | Garcia Dieguez R.,Hospital Clinico Quirurgico Hermanos Ameijeiras | Lima Perez M.,Hospital Clinico Quirurgico Hermanos Ameijeiras
Revista Cubana de Medicina | Year: 2010

INTRODUCTION: the occurrence of nauseas and vomiting from chemotherapy are a significant complication. With appearance of antiserotoninergics 5HT3 (AR 5HT3) combined with steroids, have allowed a great control of these symptoms. OBJECTIVE: The aim of present paper is to asses in a economic way two alternatives for antiemetic tratment in cancer. METHODS: Some techniques of economical assessment to two alternatives of antiemetic treatment were used. For the first line, the cost minimization (CM) technique including the Granisetron hydrochloride schemes plus Dexamethasone and Ondansetron hydrochloride plus Dexamethasone. The cost-effectiveness analysis (CEA) assessed the alternative treatment after the scheme failure containing Ondansetron; we performed mean cost-effectiveness (MCE) and incremental cost-effectiveness (ICE) analyses, as well as the sensitivity analysis. RESULTS: For the treatment schemes used in the first line by patient with treatment, it is possible to achieve a saving of $0.76 in the moderately emethogenic chemotherapy (MECM) and the highly emethogenic chemotherapy (HECT). In MCE, the option using Ondansetron as a second line treatment for MECM is of $22.77 and of $4.034 for scheme uses Granisetron for each controlled case. Therapy for HECT using Ondansetron needs %65,41 and option using Granisetron needs $13.45 for each controlled patient, respectively. In the case of ICE a nonsatisfactory result of $1.490 for scheme containing Ondansetron/controlled additional case in MECM, and of $3.140/controlled additional case for HECT. CONCLUSIONS: Antiemetic treatments with a higher economical save as first-line antiemetic therapy is that using Ondansetron, and in second line the scheme using Granisetron.

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