Research and Reports in Gynecology and Obstetrics

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Pharmacovigilance: Latin America overview and future of data management

Joint Event on International Conference on Palliative Care, Obstetrics and Gynecology & International Conference on Stroke and Clinical Trials
February 28-March 01, 2019 | Paris, France

Mariana C M

Sao Paulo University, Brazil

Scientific Tracks Abstracts : Res Rep Gynaecol Obstet

DOI: 10.4066/2591-7366-C1-002

Abstract:

Since when it was observed that medicines can cause adverse events in the human body, new organizations/institutions were created to evaluate this data. Later, the collection of adverse events/incorrect use/ unexpected benefit reports was instituted in many countries. Furthermore, this data began to interfere in the Health Authorities decision in authorizing the marketing of the medicines depending on their risk profiles. In Latin America, the pharmacovigilance discussions started in 1999 in most countries and the implementation of data collection activity was consolidated from 1992 to 2018, when the last countries joined the Uppsala drug monitoring program. Despite of having a developed analysis of the local data, all Latin America countries don’t accept electronic case submission and all the risk analysis/signal detection is done manually/ electronically from the data received by paper, via e-mail and in the HA’s website. In contrast to the treatment and receiving of data comparing all HA’s in the world, there is a transformation process happening in the pharmaceutical companies. The artificial intelligence is changing the scenario of case receipt, collection of information from different sources and case processing in which the HA’s will have to follow.

Biography:

Mariana C M is a pharmacist from UNICAMP University and has completed her MSC in biochemistry at the age of 27 years from University of São Paulo, Brazil. She has over 8 years of experience with pharmacovigilance. She spent 6 years in Bayer and now works in the Local Safety Officer team (LATAM), Brazil. 

E-mail: mari.cal.manzini@gmail.com

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