Latin America

The main objective of this chapter is to develop educational activities with the aim to increase knowledge and to ensure trainings in the field of Pharmacovigilance. We would like the Latin-American chapter to be an independent forum for people working in regulatory agencies, academia, hospitals, and also in pharmaceutical companies. Since its creation, new members from Latin America have joined ISoP.

COVID-19 vaccine vigilance.

Organized by the ISoP Latin-American chapter, the Vaccines SIG, and the Israel Chapter.

Replay of March webinars are available for ISoP members.

Not yet a member? Please join ISoP and watch all the recorded webinars.  

• 04 March 2021 at 14.00 UTC
  Rebecca Chandler: Efforts of the UMC to support global vaccine safety.
• 10 March 2021 at 14.00 UTC
  Robert Chen and Comfort Ogar: Cohort Event Monitoring (CEM) of Health Care Workers (HCW) receiving COVID-19 vaccines using mobile apps
• 17 March 2021 at 14.00 UTC
  Fernanda Tavares: Methods for vaccine safety surveillance and challenges in the context of COVID-19 vaccination

To view the recorded videos on our YouTube channel, click here.

The elected Executive Committee (EC) of the new Latin American (LATAM) ISoP chapter is as follows (in alphabetic order):

• Helaine Carneiro Capucho, Universidade de Brasília (Brazil)
• Rosa María Papale, Argentine Association of Pharmacovigilance (Argentina)
• Liliana Vargas Neri, The Children Hospital of Mexico Federico Gómez (Mexico)
• Patricia Zuluaga, Colombian Association of Pharmacovigilance (Colombia)

ISoP LATAM Chapter Elections SOP and timeline

The Executive Committee (EC) and Advisory Board (AB) of the International Society of Pharmacovigilance (ISoP) after several months of discussions with current leaders of both ISoP LATAM and Mexico Chapter made an executive decision in September 2020 to form a comprehensive LATAM chapter for all members in LATAM countries, including Mexico.

• UBA (National University of Buenos Aires)
• UNC (National University of Córdoba, Argentina)
• ANMAT – Argentina (National Administration of Drugs, Food and Tec. Medicine)
• SAFv (Argentina Society of Pharmacovigilance)
• Society of Pharmacovigilance of Venezuela
• ANVISA (Brazil)
• Members of pharmaceutical Industry (only on individual basis)

The very first beginning of this chapter was the ISoP 8th Annual Meeting, held in Buenos Aires, Argentina, and organized by the Argentina Society of Pharmacovilance as local team. This idea was born in 2002, at the 2nd ISoP Annual Meeting: Murilo, Luis, Luisa and Raquel dreamt there about an ISoP Meeting held in Cataratas del Iguazú, the wonderful falls situated in the border of Argentina and Brazil. And the work of disseminating educational material in our languages (mainly in Spanish) started several years later: a Pharmacovigilance book in Spanish was published in 2007 with the aim of providing some useful information in a format easily available for clinicians and with contents adapted to their needs and interest. Between 2007 and 2009, Spanish translations of WHO Drug Information were published by the SAFv, with the same objective.

Published in September 2007, in collaboration with the International Society of Pharmacovigilance, this 300- page textbook is an important contribution to Pharmacovigilance literature in Spanish with a particular focus on Latin America. It is well referenced and contains many diagrams and tables. The aim of this book, targeted at clinicians, general practitioners and medical and pharmacy students, is to emphasise the importance of pharmacovigilance to enhance and improve patient safety, and physician’s reports, as well as stimulate spontaneous reporting, and dismiss the misconception that pharmacovigilance is unfeasible in developing countries… (Uppsala Reports 40, January 2008, UR40 January 2008).

Teaching Pharmacovigilance in Universities

9-10 May 2019, Cordoba – Argentina

This Symposium was devoted exclusively to the teaching of Pharmacovigilance and adverse effect in Universities. Please read the symposium report.

Symposium agenda (with links for youtube free-access videos of presentations)

ISoP LA Chapter 5th Symposium in Sao Paulo, Brazil

29-30 October 2018 (Sao Paulo University)

The 5th Symposium of the ISoP Latin-American chapter was successfully held in the School of Public Health, Sao Paulo University, on 29th and 30th October 2018.

Topics included: Pharmacovigilance and Public Health, Pharmacovigilance in Universities, Signal Detection, Risk Management Plans in Latin-America, Challenges in Biotherapeutics, and Registries, among others.

For further information, click here for the symposium flyer.

ISoP LA Chapter 4th Symposium in Mexico City, Mexico

5-6 December 2017 (Auditorium Hospital Angeles Acoxpa)

In collaboration with the ISoP Mexico Chapter.

The 4th Symposium of the ISoP Latin-American chapter was held in México city, México, as part of educational activities organized with the aim to increase knowledge and to ensure trainings in the field of Pharmacovigilance. The venue was the conference room of the Hospital Ángeles Acoxpa.

The programme included the Importance of Pharmacovigilance in Public Health, Educational Strategies in Pharmacovigilance in Universities, Studies in Pharmacovigilance, Risk Management Plans at global and local level, Increasing and Improving spontaneous reports, Pharmacovigilance from the view of patient and Pharmacovigilance in Biotherapeutics among others.

Please click here for the programme.

ISoP members living and working in Latin-American countries enjoyed a complimentary registration, kindly offered by the sponsor.

ISoP LA Chapter 3rd Symposium in Bogotá, Colombia

25-26 August 2016 (Universidad del Rosario, Bogotá, Colombia)

A vibrant and crowded Third Symposium of the ISoP Latin-American chapterwas held in the Universidad del Rosario, Bogotá, Colombia, on 25th and 26th August 2016, under the chairmanship of the President of the Latin-America chapter, Prof. Luis Alesso.

The Scientific Programme, coordinated by Raquel Herrera Comoglio, focused on the present situation of Pharmacovigilance in the region, medication errors and local implementation and results of risk management plans.

Please click here for the programme.

This Symposium was also an important opportunity to introduce the recently established Colombian Association of Pharmacovigilance.

Speakers contributing include those from Colombia (Carlos Maldonado Muete, Jorge Machado-Alba, Carlos Bustamante Rojas, Rosa Ángela Caro Rojas, Dieric Díaz), Brazil (Cristina Andrusaitis Sandron and Eliane Rodrigues de Castro), Argentina (Laura Onetti and Raquel Herrera Comoglio), ISoP Executive Committee (Brian Edwards and Luis Alesso), the Uppsala Monitoring Centre (Pia Caduff) and Regulatory Agencies from the wider Americas (Ariel Arias, Health Canada), Rosana Ramírez (INVIMA, Colombia), Márcia Gonçalves de Oliveira (ANVISA, Brazil) and Paola Elena González Martínez Rogelio Ríos Quintana (COFEPRIS) who all shared their expertise and experience.

The audience participation, as arranged by the Colombian Association of Pharmacovigilance, exceeded expectations with 206 enthusiastic attendees from 10 countries: Argentina, Brazil, Colombia, Chile, Guatemala, México, Spain, United Kingdom, Uruguay and Sweden. Among these, there were 44 Universities representatives, 18 from Latin-American Medicines Agencies (15 staff members from the Colombia INVIMA), Government, Community Hospitals and Health care institutions’ staff and 74 Pharmaceutical Industry representatives.

The generous sponsorship of FIFARMA (Federación Latinoamericana de la Industria Farmacéutica) allowed all of them to participate in the Symposium free of charge in the charming environment of the venue.

The organizers, Luis Alesso and Raquel Herrera Comoglio, especially acknowledge the hosting arranged by the Universidad del Rosario, and the welcoming words and participation of Ana Isabel Gómez Córdoba, Vice-Dean of the School of Medicine.

Bogota Declaration

ISoP LA Chapter 2nd Symposium in Sao Paulo

Brazil 10-11 September 2015 (Sao Paulo University)

The Second Symposium of the ISoP Latin-American chapter was held in the Public Health School, Sao Paulo University, Brazil, on 10 and 11 September 2015, under the chairmanship of the President of the Latin-America chapter, Prof. Luis Alesso.

The Scientific Programme, coordinated by Raquel Herrera Comoglio, was a well-balanced combination of the fundamental basics and practice of pharmacovigilance, as well as the most recent challenges in drug regulation and use. Usefulness and the current place of spontaneous reporting in the region and the systematic collection and analysis of adverse effects in patients’ registries deserved special attention in relevant presentations.

Speakers from Brazil (Adalton Ribeiro, Anthony Wong, David Titton, Eliane Rodrigues de Castro, Fernanda Vianna, Maria Eugenia Cury and Valderilio Azevedo), Argentina (Laura Onetti, Gustavo Casado, María Teresa Serra and Pedro Lipszyc), ISoP Executive Committee (Brian Edwards and Hervé Le Louët) and the Uppsala Monitoring Centre (Elki Sollenbring and Pia Caduff) contributed with their expertise and experiences to lively sessions.

Please click here for the programme.

One hundred-ten participants from Brazil and other Latin-American countries attended the Symposium free of charge and actively participated in debates. Most of them (85%) were academia, clinicians from hospitals, pharmacists, regulators and students. Twenty professionals from Industry attended this event;
This symposium was supported by FIFARMA (Federación Latinoamericana de la Industria Farmacéutica), and their sponsorship allowed free-registration and ensured a smooth and efficient logistic.

The organizers, Luis Alesso and Raquel Herrera Comoglio, especially acknowledge the School of Public Health of the Sao Paulo University, one of the most prestigious Latin-American Universities, for having provided the venue for free, and particularly its representative at the Meeting, Prof. Nicolina Romano Lieber, for her interest and participation in the event.

ISoP training course in Sao Paulo, Brazil

26-28 March 2015

In co-operation with the Brazilian national agency ANVISA and ISoP’s Latin America chapter View Course

ISoP LA Chapter First Symposium
“Fostering pharmacovigilance in Latin America”

2-3 October, 2014 – Buenos Aires

The first Symposium of the ISoP Latin-American chapter, held in Argentinian Medical Association, Buenos Aires, Argentina, on 2nd and 3rd October 2014, was organized by Prof. Luis Alesso and Raquel Herrera Comoglio.

60 professionals (ISoP members and non-ISoP members) attended the Meeting.

The Programme focused on the following topics:

• Pharmacovigilance in hospitals
• Registries
• Pharmacovigilance in Universities
• Signals in local databases
• New challenges from Biological therapies

“Patient safety in clinical trials”

2-3 September, 2014 – Buenos Aires

The course conceived by Brian Edwards and coordinated by Raquel Herrera Comoglio was attended by 60 professionals from CROs, Universities and Pharmaceutical Industry, as well as staff from Regulatory Agency. Speakers were: Luis Alesso (ISoP), Brian Edwards (ISoP), Hervé Le Louet (ISoP), Susana Vásquez (EE.UU), Agustina Bisio (ANMAT), Inés Bignone (ANMAT), Pablo Bazerque (Past Director of ANMAT). Dr. Pedro Lipszyc, Guillermo Di Girolamo and Roberto Diez acted as chairmen.
See picture below.