Examinando por Materia "Legislación de Medicamentos"

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Acceso abierto
Buenas prácticas de distribución y transporte de productos farmacéuticos según la normativa Resolución Ministerial N° 833-2015/MINSA en la droguería Biomedical Logistics del distrito de Punta Hermosa – Lima Metropolitana 2021–2022
(Universidad Privada Norbert Wiener, 2022-05-20) Mendoza Blancas, Darghi Tifhany Kiara; Rendon Poma, Yesabel; Rojas Wisa, Oscar Favio
The general objective of the research was to determine compliance with Good Distribution and Transport Practices (GDP&T) for pharmaceutical products, according to Ministerial Resolution N° 833-2015/MINSA, at the Biomedical Logistics drugstore in the Punta Hermosa district of Metropolitan Lima from 2021 to 2022. The methodology applied was the analytical method, with a quantitative approach, a basic type, a non-experimental design, and a cross-sectional scope. A 29-question questionnaire was used as the instrument for data collection, and it was answered by 65 people who actively participate in the distribution and transport process at the drugstore. Results: The statistical results showed that 60% represented total compliance, 38% partial compliance, and 2% non-compliance with GDP&T. The result demonstrates that compliance is partial and limited at the Biomedical Logistics drugstore. Therefore, measures must be taken to raise the percentage of compliance in order to ensure the quality and integrity of medications for the drugstore's final clients.
Acceso abierto
Nivel de conocimiento sobre la normativa en el Perú para el registro sanitario de los dispositivos médicos en los alumnos de noveno ciclo y alumnos de la segunda especialidad de Asuntos Regulatorios de la Facultad de Farmacia y Bioquímica de la Universidad Norbert Wiener en el periodo 2017-II
(Universidad Privada Norbert Wiener, 2018-04-04) Velita Robles, Richard Heston; Rodriguez Vila, Maribel Verónica
The objective of this research was to determine the level of knowledge regarding Peruvian regulations for the sanitary registration of medical devices among ninth-cycle undergraduate students and second-specialty postgraduate students in regulatory affairs at the Faculty of Pharmacy and Biochemistry of Universidad Norbert Wiener. This observational, cross-sectional study was conducted over a three-month period, from December 2017 to February 2018, in classroom settings. Surveys were administered to both undergraduate and postgraduate students, and a total of 65 completed surveys were obtained. The questions were based on current Peruvian regulatory frameworks. The results obtained indicate the following: For Law No. 29459, among undergraduate students, 63.2% demonstrated a deficient level of knowledge, 26.3% a regular level, and 10.5% an optimal level, with none achieving an excellent level. Among postgraduate students, 25.0% demonstrated a deficient level, 50.0% a regular level, 5.3% deficient level, 8.8% optimal, and 1.8% excellent. Another evaluation among postgraduate students showed 75.0% deficient level, none regular, 12.5% optimal, and 12.5% excellent. Regarding Amendments to the law, 77.2% of undergraduate students exhibited a deficient level, 14.0% a regular level, 8.8% optimal, and none excellent. Among postgraduate students, 87.5% were deficient, 12.5% regular, with none at the optimal or excellent levels. For TUPA regulations, undergraduate students scored 52.6% deficient, 35.1% regular, none optimal, and 12.3% excellent. Postgraduate students scored 37.5% deficient, 62.5% regular, with none achieving optimal or excellent levels. Finally, regarding the knowledge of sanitary registration regulations for medical devices, 82.5% of undergraduate students demonstrated a deficient level, 15.8% regular, 1.8% optimal, and none excellent. Among postgraduate students, 75.0% were deficient and 25.0% regular, with none achieving optimal or excellent levels. In conclusion, the study demonstrates that both undergraduate and postgraduate students have predominantly deficient knowledge regarding Peruvian regulations for medical device registration, with only a small percentage achieving regular or optimal levels. These findings highlight the need for enhanced training and educational initiatives in regulatory affairs within the Faculty of Pharmacy and Biochemistry.