Francielli Melo

Company: ANVISA Brazil

Job title: Health Regilatory Specialist

Bio:

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 hold a Ph.D. in Health Sciences with a focus on Genetics, which supports my in-depth evaluation of innovative therapies. I have contributed to the development of regulatory frameworks across multiple areas, including implantable devices and advanced therapy medicinal products (ATMPs). My work includes the assessment of numerous marketing authorizations and clinical trials for cell and gene therapies, bringing a unique perspective that integrates implantable products and biological materials. Internationally, I have participated in the WHO working group on Cell & Gene Therapy, contributed to the drafting of the ICH S12 guideline on biodistribution for gene therapies, and currently serve as a member of the ICH Discussion Group on Cell and Gene Therapy.

Seminars:

Establishing Regulatory Pathways for Cell & Gene Therapies in Brazil 12:00 pm

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 existRead more

day: Conference Day Two