Pharmacovigilance news
Covid vaccines: this is what the AIFA report reveal after 6 months of administration
At 6 months after the first administrations, 423 are the reports of fatal events, but only 7 are confirmed. Here is the full AIFA report.
Pharmacovigilance news
At 6 months after the first administrations, 423 are the reports of fatal events, but only 7 are confirmed. Here is the full AIFA report.
After Brexit there were numerous doubts regarding the data flow from EU to UK: in fact, since it is no longer part of the European Union starting from January 2021, it was necessary to find an agreement between the parties, so that European data can circulate safely on British territory.
Complaint management is an activity in which pharmacovigilance and quality can intersect. This was discussed at the AFI webinar “Pharmacovigilance and quality session”, where Recipharma Italia Srl led its example.
Complaint management is a procedure that affects every company, but in the pharmaceutical field, it can also have consequences on the patient's health. Let's see how to handle it.
In the difficult relationship between global and local, KPIs can help for monitoring activities. It was spoken about at the AFI webinar “Pharmacovigilance and quality session”.
The quality system is a fundamental part of pharmacovigilance and is usually in charge of the quality assurance department. How to manage it if there isn't a dedicated staff?
On 27th November 2020 was held the AFI symposium "Pharmacovigilance and quality session", dedicated to the quality system and complaints management, in which field experts shared their experiences within their companies, all different from each other.
What are the regulations in non-EU countries? And how to manage the requirements between global and local? The answer was given at the EU PhV Congress held on 26th and 27th November of which we were sponsors.
How PSPs and MRPs can be useful from a pharmacovigilance point of view? It was discussed at the European Pharmacovigilance Congress held the 26th and 27th November and of which we were sponsors.
What kind of role does communication with patients play [...]
This year too took place the European Pharmacovigilance Congress, arrived at its fourth edition. Peculiarity of this year is the virtuality of the event, which nevertheless gave the opportunity to participate to even more people from all over the world. Here is how the two days have been held.
The health emergency caused by Covid-19 has put a strain on health professionals and pharmaceutical companies. The growing demand for drugs and their off label use has also had an impact on pharmacovigilance. Here is how some of the main actors dealt with it.
It was released just few hours ago the news of an update of 23.0 MedDRA dictionary version. The Coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonized and standardized approach for the coding and reporting of infection as a global health issue.
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: [...]