Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs and Pharmacovigilance Analyst SCR Consulting Peru As part of the development of the pharmacovigilance system in Peru, since the publication of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products (Supreme Decree No. 016-2011-SA), the preparation and presentation of the […]
Q.F. Luz Marianee Castañeda Saavedra Quality and Regulatory Affairs Specialist SCR Consulting Peru BACKGROUND OF THE REGULATION OF THE SANITARY REGISTRATION OF PHARMACEUTICAL PRODUCTS In the late 1990s, with the enactment of General Health Law No. 26842 in Peru, it was established that the registration of medicines in the Sanitary Registry was automatic, requiring only […]
Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs, Safety and Efficacy Analyst SCR Consulting Peru With the enactment of the Law No. 29459: “Law on Pharmaceutical Products, Medical Devices and Health Products” in 2009; and subsequently with the approval of the “Regulations for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health […]
En el complejo y riguroso mundo de las industrias farmacéutica, cosmética y de dispositivos médicos, la gestión de asuntos regulatorios desempeña un papel crucial para garantizar que las empresas no solo cumplan con las normativas vigentes, sino que también protejan el bienestar de la salud pública. En este contexto, los profesionales encargados de los asuntos regulatorios, con su profundo conocimiento y experiencia, [...]
Q.F. Idaly Jazminy Morote Guzmán QA Specialist & Biologics and Drug Regulatory Affairs Coordinator SCR Consulting Peru Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consultores Bolivia The Pan American Network for Drug Regulatory Harmonization (PANDRH), made up of the Drug Regulatory Authorities of 35 Member States and representatives of the […]
Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of medicines are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Medicines Regulatory Authority must work together to ensure that all […]
Q.F. Walther Ricardo Vicente MallmaQA Specialist & Regulatory Affairs Coordinator – Medical DevicesSCR Consulting Peru In Peru, medical devices are regulated by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). DIGEMID, as a line organ of the Ministry of Health, supervises all aspects related to the approval, denial, modification of the sanitary registration of […]