Committees

Legal and Regulator Affairs Committee: South & Central America

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

Headshot of

Co-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