From pharmacogenetics to personalized medicine: A Cuban regulatory perspective

6^th International Conference and Exhibtion on Pharmaceutical Regulatory Affairs and IPR

September 29-30, 2016 Orlando, USA

Diadelis Remirez Figueredo

National Centre of the State Quality Control of Drugs & Medical Devices, Cuba

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The science of pharmacogenomics has advanced significantly in the last five years, but it is still in infancy and is mostly used on research basis. The pharmacogenomics helps identify inter-individual variabilities 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. The aims of this work are to present the bases of pharmacogenetic, the advantage and challenges of this specialty, the main enzymes characterized for the genetic polymorphism and the existing regulations about this topic (EMA, FDA, ICH) and Cuban Regulatory perspective, taking into account the increase of biological product registration. We will show the main biomarkers for pharmacogenetics studies and a general guidance for submission of this type of research. The hope for the future is that through personalized medicine, doctors and patients will be able to make better-informed choices about treatment. This treatment will avoid the adverse drug reaction to the medication and will improve the diagnosis diseases as well as the prevention and treatment of diseases.

Biography :

Email: diade.remirez@infomed.sld.cu