Training program Capacity Building in Biotherapeutics and Cell/Gene Therapies in Latin America provides an overview of a year long training comprising of online modules (one of which was created de novo), asynchronous webinars and in person training with a focus on specific regulatory issues pertaining to biotherapeutics and cell and gene therapies. In this training program, learners were provided with basic information about biotherapeutics and cell and gene therapies including development, raw materials used in clinical trials and manufacturing and follow up, followed by in depth training in these areas through a webinar and in person training. The in person training was held at the University of Chile in Santiago which is a potential site for an APEC Center of Excellence. The in person training compared the development and regulatory issues of cell and gene therapy products to conventional biotherapeutics complete with case studies. The year-long training demonstrated the great need for these types of training in the Latin American region and provided the opportunity to gauge the competency of institutions in Latin America as a hub for Center of Excellence. The goal of the year-long training was to fill the gap in knowledge associated with certain regulatory aspects of biotherapeutics and cell and gene therapies.
The Online module can be accessed via https://cos.skillstack.northeastern.edu/browse/batl/courses/cell-and-gene-therapy-international-regulatory-sciences
The Webinar materials can be accessed via https://drive.google.com/drive/folders/1vn4XZXh_gPNqq63dPX67DDL3NQcQ_0sY?usp=share_link
The in person training materials can be accessed via https://drive.google.com/drive/folders/1qHmFti-JmpiLsHHXji49CQ1ZNmNn8kYx?usp=share_link