Chile: ISP met with FDA authorities
Within the framework of the existing cooperation between the Institute of Public Health of Chile (ISP) and the U.S. Food & Drug Administration (FDA), on November 15 authorities of both entities met at the Institute’s facilities with the aim of coordinating and defining activities of mutual interest.
The meeting was attended by Dr. María Judith Mora, Director (S) of the Institute of Public Health; Michelle Rodríguez, Ph.D., Director of the FDA Office for Latin America; Peter Baker and Gonzalo Ibáñez, representatives of the FDA in Chile. In addition, Dr. Janepsy Díaz Tito, Chief of the Departments of Scientific Affairs and Medical Devices attended; Alejandro Salinas Rivera, Head of the International Relations and Cooperation Unit; and Patricia Carmona, Head of the Sub-Department of Registration and Health Authorizations of the ISP.
In addition, the FDA offered its collaboration to publicize its experience in the regulation of Medical Devices, an activity that will be carried out in conjunction with the Department of Medical Devices of the ISP. He also gave his support to the Institute for the development of the XIV Scientific Conference 2019, which will take place on May 14, 15 and 16, 2019 and organized by the Department of Scientific Affairs.
At the conclusion of the meeting, the FDA expressed interest in carrying out activities with the Department of the National Agency of Medicines (ANAMED), with the purpose of identifying gaps in the accreditation process for the Pharmatheutical Inspection Co-operation Scheme (PIC / S). PIC / S is a cooperative agreement between the Health Authorities in the field of Good Manufacturing Practices (GMP). Currently PIC / S is composed of 52 authorities from all over the world, being COFEPRIS (Mexico) and ANMAT (Argentina) the only ones in Latin America.