Training - ISoP - UMC Training
3rd ISoP-UMC Training
7-9 September 2016
From case reports to benefit-harm assessment and risk communication
This three day-course was conducted with expertise from UMC and ISoP, and designed for interdisciplinary groups to learn and work together in contributing to patient safety when medicines are used. At the end of the course, the participants were expected to understand the complexities of pharmacovigilance and to use various sources of information about risks and appropriate tools to advance better detection, monitoring, reporting and prevention. Assessment of causality and the balance of benefit-harm of medicinal products and communication were other important course contents that aligned regulators and industry to promote product safety.
Lectures, working groups and panel discussions were the main training method.
The programme covered topics such as:
- Individual case safety reports and Spontaneous Reporting Systems
- Signal detection and management
- Clinical assessment of signals
- Drug-drug interactions
- Assessment of benefits and harms
- Risk communication
- Counterfeiting of medicinal products
- Medication errors and off-label use
- Pharmacovigilance in Public Health Programmes
There were 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 lectures were in Spanish and the others had simultaneous translation.
Click here to download the brochure – English (in PDF)
Click here to download the brochure – Spanish (in PDF)
Click here to download the brochure – Portuguese (in PDF)
Please click here to download the final programme (in PDF)
Hotel Jose Antonio
28 Av. Julio No 398 Miraflores
Lima 18 – Peru
In the exclusive district of Miraflores (a residential & commercial area) three minutes away from the pacific ocean and a few minutes away from commercial areas, culture, cinemas, restaurants, the hotel venue is located thirty minutes away from the international airport Jorge Chavez with many destinations in South America (There are direct and stop-over flights to Lima from the main capitals of the world) and twenty minutes away from the historical downtown of Lima.
Entering in Peru, useful information at
Lima is the capital and the largest city of Peru (population of almost 10 millions). With a rich historical and architectural heritage, Lima is headquarters to major banks and many national companies and enjoys a very privileged location in the heart of South America.
Average temperature for the month of September would be 18 °C.
Historical Center of the Lima city
“Cultural World Heritage Site” by UNESCO
More information about Lima and Peru at
We recommend the following hotel (hotel venue):
Hotel Jose Antonio
Single room from 130 US$ (breakfast and tax included) – Rooms subject to availability
Please note this hotel is now fully booked. Contact ISoP Administration for information about hotels in Lima.