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February 28-March 01, 2019 | Paris, France
Palliative Care, Obstetrics and Gynecology
Stroke and Clinical Trials
International Conference on
Joint Event on
International Conference on
&
Journal of Research and Reports in Gynecology and Obstetrics | Volume: 3
Pharmacovigilance: Latin America overview and future of data management
Mariana C M
Sao Paulo University, Brazil
S
incewhen 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.
Speaker 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:
mari.cal.manzini@gmail.comMariana C M
, Res Rep Gynaecol Obstet, Volume 3
DOI: 10.4066/2591-7366-C1-002