Select Page
Select Page

Training - ISoP - UMC Training

The sixth pharmacovigilance training course jointly organized by ISoP and UMC was scheduled on 24-26 September 2018 in Guayaquil (Ecuador)

The International Society of Pharmacovigilance (ISoP) and the Uppsala Monitoring Centre (UMC) have a common interest to promote scientific research and practice through the mutual exchange of information on adverse events and risks related to medicinal products.

In January 2014, a first Memorandum of Understanding (MOU) was signed by both parties, which establishes a strategic framework for a training collaboration. A primary focus was on Asia, a continent that accounts for 60% of the world’s population. It was considered that harmonisation of safety reporting requirements and pharmacovigilance systems would be of benefit for public health both on a global and a national level. After the Manila training in June 2014, the second Pharmacovigilance training course jointly organized by ISoP and UMC was held on 12-14 January 2015 in Mysore, India.

In January 2016, a revised Memorandum of Understanding was signed by ISoP and UMC officials. The Latin America and Caribbean countries vary greatly in terms of level of pharmacovigilance. UMC and ISoP have identified a capacity building need in the Latin America region and a need to further strengthen pharmacovigilance systems. Therefore, the third pharmacovigilance training course jointly organized by ISoP and UMC took place in Lima, Peru from 7 to 9 September 2016 and the following year in Panama in September 2017.

6th ISoP-UMC Training
Guayaquil, Ecuador
24-26 September 2018

Pharmacovigilance concepts and tools in Latin America.


This three day-course was conducted with expertise from UMC and ISoP and delivered theory and experiential learning of pharmacovigilance, including but not limited to management of individual case safety reports, signal detection and risk management and risk communication.

Target audience included regulatory agencies, hospitals, universities as well as industry professionals. Lectures, working groups and panel discussions between regulators and industry were the main training method.

At the end of the course, the participants were expected to have an overall understanding about the complexities of pharmacovigilance system, good pharmacovigilance practices and risk management to promote product safety.

The programme covered topics such as:

  • Individual case safety reports and spontaneous reporting Systems
  • Signal detection and management
  • PV Inspections
  • Assessment of risks and benefits
  • Risk communication
  • Pharmacovigilance on vaccines
  • Biotherapeutics
  • Pharmacovigilance in Public Health Programs
  • Harmonization of Pharmacovigilance

There was ample opportunity to exchange views and ideas in discussions following individual presentations, after the panel discussion at the end of the seminar and during coffee breaks.
Some main lectures were in Spanish while others had a simultaneous translation.

Programme and Brochure

Please click here to download the final programme – in English (in PDF)

Please click here to download the brochure – in Spanish (in PDF)
Please click here to download the brochure – in Portuguese (in PDF)

Meeting Venue

Courtyard Marriott

Courtyard Marriott
Av. Francisco de Orellana 236, Guayaquil, Ecuador

Located in Kennedy, comfort and convenience await at Courtyard Guayaquil with complimentary Wi-Fi, on-site parking and airport shuttles to Jose Joaquin de Olmedo International Airport (GYE) in addition to on-site dining and an outdoor pool.
All 144 soundproofed modern rooms feature free WiFi and iPod docks.
The hotel venue is situated at 2 miles from the airport.

Entering in Ecuador, land of volcanoes
Visitors from most countries, you can visit Ecuador without a visa, but you may be asked about your reason for travel and to provide evidence of a return or onward flight/bus ticket when you arrive. A passport valid for at least six months past the planned date of departure is required.

Welcome to Guayaquil!
Ecuador’s largest city, Guayaquil is a vibrant port city in Ecuador, known as a gateway to Pacific beaches and the Galapagos Islands.


Due to the busy period in September, we recommend to book your hotel as soon as possible.
Contact ISoP Administration for information about hotels in Guayaquil.

Courtyard Marriott
Av. Francisco de Orellana 236, Guayaquil, Ecuador

Hotel venue: Single room / Group rate of  75 US$ + taxes-  breakfast incl. (nights of 23-24 & 25 September / subject to availability).
For reservation, please contact the hotel directly quoting ‘ISoP UMC PV Training’. Reservations allowed until August 31 and subject to availability.
Reservations can be canceled up to August 31st at 5pm, after this date the penalty of one night’s stay plus taxes applies.