Signal Management is the process of managing safety signals in pharmacovigilance. Here's what phases it consists of and how it is performed.

Medicinal products, although useful for the treatment of diseases that can afflict humans, are not free from possible risks and side effects. It is, therefore, necessary to constantly supervise the relationship between the expected benefit and the possibility and the degree of risk of each drug. Pharmacovigilance deals with this activity. Here is in detail what it is.

Educational material was a topic addressed in the Pharmacovigilance session of the 61st AFI Symposium. Here's what emerged.

AIFA is ready! The Italian Medicines Agency has announced that the new Italian National Pharmacovigilance Network will be available.

One of the various aMMRs is the dissemination of educational material to doctors and patients. Here's how to manage it and who are the actors involved.

The AFI symposium returns to the Palacongressi in Rimini from 8 to 10 June 2022. As usual, there will be 3 days of scientific sessions accompanied by workshops and round tables. Here is the program.

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 in the pharmaceutical field? How much and what should consumers know? What effects can inaccurate communication have on users? It was discussed at the fourth edition [...]

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.

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: 11 discussion sessions, more than 150 participants and more than 30 pharmacovigilance expert speakers from competent authorities and pharmaceutical companies. The main topics of this [...]

For the third consecutive year we will be the main sponsor of the European Pharmacovigilance Congress, the event dedicated to the updates in the field of pharmacovigilance. This year the event will be held in Milan [...]

As every year in June, the AFI Symposium, the Italian conference dedicated to the pharmaceutical sector, will be held. From 5 to 7 June 2019 at the Rimini conference center, issues will be discussed with [...]

Back from the DIA Europe, which took place from 5th to 7th February 2019 in Vienna, we reported for you the intervention that most impressed us, since it warns about the risks that may occur during inspections. [...]

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.

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.

During the XI session dedicated to the pharmacovigilance of the 58th AFI Symposium, Mrs. Finizia of GSK spoke about the vaccines, the relative adverse events and vaccinovigilance. Here's what emerged.

In conclusion, Dr. Finizia of GSK concluded her speech at the 58th AFI Symposium talking about the analysis and validation of the signal and active vaccinovigilance. In order to perform correct signal detection, it [...]

The New Esudravigilance System was implemented on 11/22/2017, but the Italian integration with the European database was not painless, said Dr. Sottosanti of AIFA. Here are the latest news.

Durante la Sessione XI dedicata alla farmacovigilanza del 58° Simposio AFI la Dr.ssa Finizia ha parlato dei vaccini, dei relativi eventi avversi e della vaccinovigilanza. Ecco cosa sono gli AEFI

"The new horizons of pharmacovigilance in Italy and Europe" was the session dedicated to pharmacovigilance held on Friday afternoon at the 58th AFI Symposium.

The AFI Symposium took place in Rimini at the convention center on 6-7-8 June. The topic of this 58th edition was the technological innovations in the medical field.

The first edition of the European PharmacoVigilance Day took place on 30th November 2017 in Milan. The topics of the speakers were: the procedural changes, the news of EudraVigilance and the importance of signal detection.

During the European PharmacoVigilance Day on 30th November 2017, Mr Garlanda of Max Application introduced the analyses with SafetyDrugs 6.

The European PharmacoVigilance Day took place in Milan, the event where Mr Ghiglione revealed some news about SafetyDrugs 6.

From 7th to 9th June 2017 took place the 57th edition af AFI Symposium. Here are ten aspects raised during the seminars.

SafetyDrugs, the pharmacovigilance software made in Italy, is preparing itself for the new parameters. Here are some of the news that await you!

What developments are there in the use of 3d printing in the medical field? It was discussed at CPhI 2016. Here is what emerged.

Biosimilars is a market that has grown considerably in recent years. We talked about it at CPhI 2016 in Barcelona, which we participated in from 4 to 6 October.