Establishing Regulatory Pathways for Cell & Gene Therapies in Brazil

Time: 12:00 pm
day: Conference Day Two

Details:

  • An overview of Brazil’s current regulatory framework for clinical trial and quality submissions, based on the speakers’ interpretation of publicly available guidelines
  • Reflections on risk-based evaluation approaches, including considerations for comparability and raw material control in ATMP development
  • Observations on international regulatory convergence and where future opportunities for alignment may exist

Speakers:

Francielli Melo
Francielli Melo With over 20 years of experience at ANVISA, Brazil’s National Health Surveillance Agency, I specialize in regulatory analysis and GMP certification of health products. I Read more