Pharmacovigilance news
Several years have passed since they started talking about ICH E2B (R3): the first guide was issued in 2014, in November 2017 the transition period began and today the date of the definitive transition is announced.
Pharmacovigilance during pregnancy has a fundamental role. Pregnant women are excluded from clinical trials and therefore any data can be useful for drug profiling
Paediatric pharmacovigilance requires special attention due to the patients involved. Here's what it is and how to manage it.
Special Populations are categories of patients that differ in age or in specific disorders. Consequently, the pharmacovigilance activity is more complex in their cases. It was discussed at the third edition of the European Pharmacovigilance Congress. Here is what Giovanni Furlan, Head of security risk, Director of Pfizer, reported on geriatric patients.
There was two days of congress rich in topics: [...]
For the third consecutive year we will be the [...]
As every year in June, the AFI Symposium, the [...]
In the ICH R3 transition is essential the validation of the entire process. It is a delicate phase in which different areas are involved. In fact, it is related both to the installation of the environments, to the data conversion, and to the functioning of the software. We see below the situations in detail.
There are several companies that handle pharmacovigilance cases management with Excel, but there are many reasons why this is not the most suitable choice. Here they are in detail.
Back from the DIA Europe, which took place from [...]
The annual DIA Europe meeting dedicated to the pharmaceutical sector will be held in Vienna from 5th to 7th February 2019: 80 discussion sessions with 300 speakers and more than 35 present Agencies. Here is the program.
Social media are part of our daily life: can they also influence the pharmacovigilance sector? This is the theme of a lively debate at the European Pharmancovigilance Congress between Davide Bottalico of Takeda Italia's and Valentina Mancini of Shionogi. Here are the topics of their intervention.
Here are some valuable suggestions provided by Calin Lungu during the European Pharmacovigilance Congress on the management of duplicates.
Two seminar days, twelve in-depth topics for 26 speakers, 140 visitors. These numbers of the second edition of the European Congress of Pharmacovigilance. We have pointed out the concepts that we consider most interesting for our readers.
The participation in the European Pharmacovigilance Congress 2018 in Milan, of which we were the main sponsor, gave us the opportunity to listen to the moods of the pharmaceutical industry operators one year after the new pharmacovigilance rules entry into force. Here are the main considerations.
We asked the organizers of the event. Here are some anticipations...
One year after the entry into force of the ICH R3 what has changed, what were the difficulties and what were the improvement. These are the topics of the European Pharmacovigilance Congress second edition, an event in which SafetyDrugs will again be the main sponsor.
We were in Paris, guests of the French affiliate of a multinational pharmaceutical company, for a training session on SafetyDrugs. Here are the reflections that emerged...