Committees

Charter

The South & Central America Legal and Regulatory Affairs Committee of ISCT serves the membership and others working in cellular therapy by providing information and education regarding South & Central America and international regulations, and to address challenges in the development and harmonization of the regulatory framework in this region.  

Projects & Objectives

• Identify the cell and gene therapy regulations and regulatory authorities in each country of the region (current regulations), and educate authorities on the urgent need for CGT regulatory framework.
• Provide and promote education to regional members about issues, including:
  • Classification of cellular and gene therapy
  • Difference between minimal manipulation and complex manipulation
  • Facility definition (good manufacturing practice), requirement and control for each clinical and laboratory process (investigational/clinical- GCP), the safety of manufacturer process (GLP), Quality Assurance systems
  • Highlight the scientific rationale for each proposed use
  • Highlight the patient consent before each procedure: patients’ informed consent, safety/risk explanations, no result promises
  • Establish the rules to promote the activity and the cost related to the compassionate use of CT
  • Patients selection criteria
  • Safety measures that must be taken to prevent or to solve each adverse event/toxicity (Pharmacovigilance for Cell Therapies)
  • Establish a regional database to record the therapeutics results obtained (Centralized effectivity/safety database)
  • Minimal requirement needed for translating the basic research to clinical application
  • Minimal requirements needed to consider an experimental CT process as a potential or clinical therapy
• Engage in dialogue with regulatory agencies in South & Central America, providing them with resources and support to promote the development and maintenance of a regulatory framework for cell and gene therapies, including the application of GCP, GMP, and GLP.

The Committee

Chair

Fernando E. Figueroa, MD, FACP
Universidad de los Andes School of Medicine
Santiago, Chile

Members

Martin Hernán Bonamino, PhD
Instituto Nacional de Cancer
Brazil

Maria-Ignacia Cádiz, PhD
Universidad de los Andes, Cells for Cells S.A.
Chile

Lilia Carolina León-Moreno, PhD

El Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco, A.C. (CIATEJ)
México

María de Jesús Medina-Arellano
Institute of Legal Research, UNAM
México