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

CO-Chair

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

CO-Chair

Members

Andrés Gómez-De León, MD
Universidad Autónoma de Nuevo León, Hospital Universitario “Dr. José E. González”
Monterrey, Mexico

Carolina Sepúlveda Márquez
Instituto de Salud Pública de Chile (ISPCH)
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

Gustavo Salguero, MD, PhD, MBA
Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud (IDCBIS)
Colombia