+44-1518081136Understanding of clinical investigator about the serious adverse event reporting and its complexity in Latin America
Clinical Trials and Pharmacovigilance
September 23-24, 2019 | Prague, Czech Republic
Carmela Gelida Barboza Justiniano
Universidad Peruana Cayetano Heredia, Peru
Posters & Accepted Abstracts : J Clin Res Pharm
Abstract:
In Latin America, different efforts are being made to increase
clinical studies, working on the speed of evaluation and
approval of these. Likewise the need for new drugs and
medical devices and its offer to improvements in healthcare.
Clinical research is undertaken to elucidate product benefits,
but also to identify potential harms. The report of Adverse
event (AE) and serious AE (SAE) bring crucial information in
drug and device development.
Unfortunately, there is an increasing of requirements from
health authority that trigger in requirements by the sponsors
to the research centers, leading to a decrease in the uptake of
have a robust training and capacity building program which is
strengthening the focus on patient. Therefore, it is essential
that both researchers and coordinators genuinely understand
the impact of the information contained in the reports and
the value of quality in their evaluation.
The value proposal launched with this initiative is aimed that
academics from different universities work virtually with the
industry, in order to strengthen research centers selection
during the feasibility process, also, do a reengineering on
training of the research team focus on the observation of
patient beyond of physical or laboratory tests.
Biography:
E-mail:
Carmela.barboza@upch.pePDF HTML