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On January 22, 2021, Ronald Quiñonez Dextre, our Regulatory Affairs and Pharmacovigilance Analyst, participated in the technical meeting on the Technical Document "Manual of Good Pharmacovigilance Practices RM 1053-2020/MINSA", which was convened by the Ministry of Health of Peru, and carried out through the virtual platform Zoom, this […]
El Ministerio de Salud a través de la Resolución Ministerial Nº 404-2021/MINSA, publicada el 24 de marzo del 2021 en el Diario Oficial “El Peruano”, aprobó el listado de medicamentos para la exigencia de la presentación de estudios de equivalencia terapéutica para demostrar la intercambiabilidad, en el marco de lo dispuesto por la Sétima Disposición […]
On January 21, 2021, Walther Vicente Mallma, Specialist in Quality Assurance and Coordinator of Regulatory Affairs for Health Products and Medical Devices, and Ronald Quiñonez Dextre, Analyst for Regulatory Affairs and Pharmacovigilance, participated on behalf of SCR Consultores based in Peru. the Technical Meeting “Pharmacovigilance of Vaccines against COVID-19 […]
On December 09, 2020, Walther Vicente Mallma and Alberto Conislla Vigo, members of our Medical Devices and Health Products Regulatory Affairs team, participated on behalf of SCR Consultores, Peru headquarters, in the Virtual Technical Meeting of the Diagnostic Sector, which was convened by COMSALUD, belonging to the Chamber of […]
Library Bulletin # 20 In this issue we report that Peru approved the Technical Document – Manual of Good Pharmacovigilance Practices; as well as the Emergency Decree that dictates extraordinary measures to facilitate and guarantee the acquisition, conservation and distribution of vaccines against COVID-19. In addition, the Technical Documents were approved: 1) Guidelines for the […]
On December 11, 2020, Gianfranco Castro Camacho and Walther Vicente Mallma, members of our Quality Assurance and Regulatory Affairs teams for Medical Devices, participated on behalf of SCR Consultores, Peru headquarters, in the Virtual Workshop: Cold Chain Management in Pharmaceutical Products. and Biological “Challenges and advances in Latin America”, […]
Noticias Ley que Regula, Autoriza, Asegura y Garantiza el uso de Oxígeno Medicinal en los Establecimientos de Salud Públicos y Privados a nivel nacional El Congreso de la República a través de la Ley Nº 31113, publicada el 21 de enero del 2021 en el Diario Oficial “El Peruano”, ha dado la “Ley que Regula, […]
Noticias Aprueban Formato de Notificación de Eventos supuestamente atribuidos a la Vacunación e Inmunización (ESAVI) La Dirección General de la DIGEMID a través de la R.D. Nº 001-2021-DIGEMID-DG-MINSA, publicada el 15 de enero del 2021 en el Diario Oficial “El Peruano”, aprobó el “Formato de Notificación de Eventos supuestamente atribuidos a la Vacunación e Inmunización […]
On December 04, 2020; Rosa Campos Yaipén, our Pharmacovigilance and Drug Safety Coordinator, participated on behalf of SCR Consultores, based in Peru, in the Workshop II: Good Pharmacovigilance Practices “Implementation Challenges in Latin America”, which was organized and convened by LATFAR. The speakers at this event were Dr. […]
Noticias Modifican el Reglamento de Establecimientos Farmacéuticos La Presidencia de la República a través del D.S. Nº 004-2021-SA, publicado el 11 de enero del 2021 en el Diario Oficial “El Peruano”, aprobó lo siguiente: Modificación de los artículos 16, 18, 22, 23, 24, 27, 38, 71, 75, 95, 109, 116 y 125 del Reglamento de […]