| 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 | pdf | 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 |
| dc.relation.references | Aksu, B., & Yegen, G. (2014). New Quality Concepts in Pharmaceuticals. Journal of Marmara University Institute of Health Sciences, 4(2), 96–104. https://doi.org/10.5455/musbed.20140327095117 | spa |
| dc.relation.references | Balmo M., L. M. I. (2013). Quality Risk Management in the Pharmaceutical Industry. Quality Access to Success, 14(136), 73–75. | spa |
| 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 |
