Pharmacovigilance in Latin America: challenges and synergistic partnerships between regulators, industry associations and marketing authorization holders towards a harmonized and robust PV system in the region

The PV regulatory landscape has been changing in LATAM in the past 10 years. While this is an important step towards access to safe and high quality medicines, there is a need for harmonization, as e.g. for ICSRs, the submission timelines for expedited reports can vary from 24 hours to 15 days and from local format and language to English CIOMS I. This divergence hinders efficiency, exchange of information among regulators and proactive safety science. By seeking harmonisation and ensuring all stakeholders are aligned, we can advance the culture of pharmacovigilance in Latin America.

In LATAM, the collaboration between regulators, trade associations and industry has been essential to 1) raise awareness on the diverse PV requirements among the countries (1) and the impacts and risks of such diversity to patients, regulators and industry (2) and 2) enable partnerships for capability building and more resource-efficient processes. Some initiatives on this are: a) PAHO Initiative for the joint evaluation of PSURs, RMPs, and PBRERs by NRAs, b) 6th ISoP-UMC PV training and c) RMP expert meeting organized by the Mexican Association of Pharmaceutical Research Industries (AMIIF), d) EFPIA SiGiR support for E2B implementation, e) Vigilantia (3)

1 Work developed by Sindusfarma LATAM working group
2 In-progress work being performed by EFPIA International Pharmacovigilance Group (EFPIA IPVG) LATAM working group
3 Work developed by FIFARMA

About the speaker
Renata Yoshida Shihomatsu

Renata Yoshida is a Pharm D and works as the Head of International Pharmacovigilance for Latin America at Roche. Renata has 17 years’ industry experience, 14 of which in several Pharmacovigilance roles at Abbott, Novartis and Roche. Her areas of expertise are the LATAM PV systems and strengthening of PV systems in the region. In her belief that everyone has a role to play in ensuring patient safety, she has been working for the harmonization of the PV regulations as a member of PV groups in external associations (EFPIA International Pharmacovigilance LATAM group and Sindusfarma), as well as advocating for public PV education and effective safety communications.

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