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Gestión y plan de respuesta a los riesgos asociados a asuntos regulatorios
| dc.contributor.advisor | Perdomo Fonseca, Laura Marcela | spa |
| dc.contributor.author | Alfonso Jaimes, William Ramón | |
| dc.coverage.spatial | Calle 100 | spa |
| dc.date.accessioned | 2017-09-02T17:42:23Z | |
| dc.date.accessioned | 2019-12-30T18:07:58Z | |
| dc.date.available | 2017-09-02T17:42:23Z | |
| dc.date.available | 2019-12-30T18:07:58Z | |
| dc.date.issued | 2017-06-18 | |
| dc.identifier.uri | http://hdl.handle.net/10654/16435 | |
| dc.description.abstract | El presente documento muestra las pérdidas económicas y de imagen a que está enfrentada continuamente la industria farmacéutica, debidas a la imposibilidad de comercialización de productos asociadas a sus áreas regulatorias por pérdida de registros sanitarios, pérdida de licencias de fabricación y sanciones por falta de informes oportunos a las autoridades regulatorias. La naturaleza de la industria farmacéutica hace que sea a nivel mundial un sector altamente regulado, la regulación es usualmente dada a nivel gubernamental, ya que el estado es llamado a velar por la salud de los ciudadanos. El incumplimiento de la normativa oficial puede llevar a las compañías a incurrir en onerosas multas, pérdida de imagen, retiros de producto del mercado y cierres temporales o totales de áreas de producción. Los costos asociados a estas sanciones son supremamente lesivos para la organización, y la pueden llevar al cierre definitivo de operaciones. Este documento propone a través de una metodología de gestión del riesgo minimizar las situaciones lesivas para la organización, que se puedan originar desde el área de asuntos regulatorios. El documento muestra paso a paso la propuesta de implementación del sistema de gestión de riesgo en la empresa y su aplicación directa al área de asuntos regulatorios, incluyendo el plan de respuesta asociado. La adopción de un sistema de gestión de riesgo permitirá evitar grandes pérdidas económicas a las compañías, garantizar la comercialización de productos y evitar la pérdida de imagen de la compañía. | spa |
| dc.format | spa | |
| dc.language.iso | spa | spa |
| dc.publisher | Universidad Militar Nueva Granada | spa |
| dc.title | Gestión y plan de respuesta a los riesgos asociados a asuntos regulatorios | spa |
| dc.type | info:eu-repo/semantics/bachelorThesis | spa |
| dc.rights.accessrights | info:eu-repo/semantics/openAccess | spa |
| dc.subject.lemb | INDUSTRIA FARMACEUTICA | spa |
| dc.subject.lemb | ADMINISTRACION DEL RIESGO | spa |
| dc.publisher.department | Facultad de Ingeniería | spa |
| dc.type.local | Trabajo de grado | spa |
| dc.description.abstractenglish | This document shows the economic and image losses that the pharmaceutical industry is continually facing due to the impossibility of commercialization of products, associated to the management of its regulatory areas, due to loss of sanitary registers, loss of manufacturing licenses and penalties for lack of timely reports to regulatory authorities. The nature of the pharmaceutical industry makes it a highly worldwide regulated sector, regulation is usually given at the governmental level, since the state is called to ensure the health of citizens. Failure to comply with official regulations can lead companies to incur costly fines, image loss, product recalls, and temporary or total closures of production areas. The costs associated with these penalties are extremely damaging to the organization, and can lead to the definitive closure of operations. This document proposes, through a risk management methodology, to minimize situations detrimental to the organization, which may arise from the area of regulatory affairs. The document shows step by step the proposed implementation of the risk management system in the company and its direct application to the regulatory affairs area, including the associated response plan. The adoption of a risk management system will avoid large economic losses to companies, guarantee the commercialization of products and avoid the loss of image of the company. | eng |
| dc.title.translated | Management and response plan to associated risks with regulatory affairs | spa |
| dc.subject.keywords | Pharmaceutical industry | spa |
| dc.subject.keywords | risk analysis | spa |
| dc.subject.keywords | regulatory affairs | spa |
| dc.subject.keywords | risk matrix | spa |
| dc.subject.keywords | response plan | spa |
| dc.subject.keywords | costs | spa |
| dc.publisher.program | Especialización en Gerencia de la Calidad | spa |
| dc.creator.degreename | Especialista en Gerencia de la Calidad | spa |
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| dc.relation.references | Edwards, B., & Chakraborty, S. (2012). Risk Communication and the Pharmaceutical Industry. Drug Saf, 35(11), 1027–1040. | spa |
| dc.relation.references | Fabián, O., Aponte, G., Margarita, B., Díaz, V., Elizabeth, C., & Huertas, M. (2015). La calidad desde el diseño: principios y oportunidades para la industria farmacéutica. Estudios Gerenciales, 31, 68–78. | spa |
| dc.relation.references | FIFARMA, F. L. de la I. farmacéutica. (2016). Acceso a medicamentos en Colombia en el contexto de la OCDE. Retrieved from http://fifarma.org/images/Colombiaaccess- to-innovative-medicines---OCDE-comparative.pdf | spa |
| dc.relation.references | ICH., E. W. G. (2005). QUALITY RISK MANAGEMENT Q9. Retrieved from http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html | spa |
| dc.relation.references | ICH., E. W. G. (2008). Pharmaceutical Quality System Q10. ICH HARMONISED TRIPARTITE GUIDELINE. Retrieved from http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html | spa |
| dc.relation.references | ICONTEC. (2011). NTC-ISO 31000:2009 GESTIÓN DEL RIESGO PRINCIPIOS Y DIRECTRICES. BOGOTA. | spa |
| dc.relation.references | Instituto Geográfico Agustín Codazzi. (2015). Mapa de riesgos Institucional IGAC 2015. Retrieved from www.igac.gov.co:10040/wps/.../Mapa+de+Riesgos+INSTITUCIONAL+V1+2015.x ls?...%0A | spa |
| dc.relation.references | Ministerio de Salud y Protección Social. Decreto 677 de 1995, Pub. L. No. 677 (1995). Colombia. https://doi.org/10.1017/CBO9781107415324.004 | spa |
| dc.relation.references | Ministerio de Salud y Protección Social. Resolución 1160 de 26 abril 2016, Pub. L. No. Resolución 1160, 1 (2016). Colombia. | spa |
| dc.relation.references | Shanley, A. (2016). Managing Risk in Raw Material Sourcing. Pharmaceutical Technology, (November), 58–60. | spa |
| dc.relation.references | U.S. Department of Health and Human Services, Administration, F. and D., (CDER), C. for D. E. and R., & (CBER), C. for B. E. and R. (2006). Guidance for Industry. Q9 Quality Risk Management. Rockville, MD. Retrieved from https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm073511.pdf | spa |
| dc.relation.references | Van Arnum, P. (2013). Risk Assessment of Excipients. Pharmaceutical Technology, 37, S24–S28,S30. | spa |
| dc.relation.references | Viornery L. and Goff, L. (2010). Quality Risk Management Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S. Retrieved from https://www.picscheme.org/en/publications?tri=all | spa |
| dc.relation.references | WHO Expert Committee. (2003). WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Thirty-seventh Report aA World Health Organization. Geneva. Retrieved from http://apps.who.int/iris/bitstream/10665/42613/1/WHO_TRS_908.pdf | spa |
| dc.relation.references | WHO Expert Committee. (2011). WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report. Geneva. | spa |
| dc.relation.references | WHO Expert Committee. (2013). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-seventh report. Geneva. | spa |
| dc.subject.proposal | Industria farmacéutica | spa |
| dc.subject.proposal | análisis de riesgo | spa |
| dc.subject.proposal | asuntos regulatorios | spa |
| dc.subject.proposal | matriz de riesgo | spa |
| dc.subject.proposal | plan de respuesta | spa |
| dc.subject.proposal | costos | spa |
