Diadelis Remirez Figueredo
Devices and medical equipments (CECMED), Cuba
Title: Pharmacogenetic: Regulatory considerations, cuban guidance
Biography
Biography: Diadelis Remirez Figueredo
Abstract
The science of pharmacogenomics has advanced significantly in the last five years. The Pharmacogenomics helps identify inter-individual variability in drug response (both toxicity and effectiveness). This information will make it possible to individualize therapy with the intent of maximizing effectiveness and minimizing risk. This discipline is a big challenge for regulatory authorities. The aim of this work is to present the bases of pharmacogenetic, the state of art and implications of this discipline for Latin-American countries and to show the Cuban Guidance for Industry. International literature was reviewed about the existing regulations, guidance, concept paper, scientific articles and the national regulations related with the topic. The results showed that there are several normative and guidance related with pharmacogenomic; the increase of biological product registration and authorized clinical trials in Cuba and the necessity for carrying out pharmacogenetic studies during the clinical phases of our products. We will show the main biomarkers for pharmacogenetics studies and a Cuban general
guidance for submission of this type of research. It is divided mainly in four sections: Introduction, objectives and scope, terms and definition and regulatory recommendations (reception, codification and sample storage biomarkers, and ethical considerations). This Cuban guidance will be considered the first guidance related with pharmacogenomic in Latin America.
Pharmacogenetic has several advantages in order to get rational use of drugs but still there are many challenges. The hope for the future is that through personalized medicine, doctors and patients will be able to make better-informed choices about treatment.