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.

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.

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 Medical Device Regulation 2017/745, among other innovations, defines the concept of post-market surveillance, so far only mentioned in the MDD. Here is what it is and what are the obligations for the manufacturers.

One of the most important news introduced by the MDR 2017/745 regards the medical devices Unique Device Identification. Here it is what UDI is.

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.

One of the novelties of the new Regulation 2017/745 concerns the EU Declaration of Conformity which must accompany each Medical Device. Here are the requirements for its validity. The EU Declaration of Conformity is [...]

In April 2020, the full application of the new Medical Devices Regulation (MDR 2017/745) was deferred for a year, postponing it to 26 May 2021. The period of validity of the transitional provisions (article 120) [...]

The application data of the Medical Devices Regulation (MDR) EU 2017/745 has been officially postponed, such as instituted by the EU Parliament vote on 17th April 2020.

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.

Pregnant or lactating women fall into the category of special populations. How to manage pharmacovigilance in the event of an adverse event during pregnancy? Margherita D'Antuono, Pharm D, Ph D Corporate Pharmacovigilance Director and EU [...]

The physical, metabolic and psychological processes inherent in growth from birth to adulthood, reveal that children cannot be considered small adults and cannot even be considered a homogeneous group in themselves. It is therefore necessary [...]

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 [...]

More and more pharmaceutical companies or providers of pharmacovigilance services are looking for a database that ensures compliance with the new ICH R3 regulations. In the evaluation phase, cost is a central element and in [...]

When you begin to work independently on a new work tool, the need to be assisted can arise. It also happens when a new customer starts working with SafetyDrugs. This is the reason why we [...]

It takes just four days to learn all that is useful to know to make SafetyDrugs a daily work tool. It is the safety database developed by Max Application for the management of pharmacovigilance. When [...]

The American and the Chinese are the main Medical Devices market in the world. In these Countries the devices classification is different from the European one. How to proceed to obtain the marketing authorization?

A few months from 26th May 2020, the date of entry into force of the (EU) 2017/745 Regulation on Medical Devices, doubts arise about the real possibilities of meeting the deadlines. Here are the considerations emerged [...]

On 26th May 2020 the 2017/745 EU regulation on medical devices will entry into force. It was discussed at 59th AFI Symposium, the Italian event dedicated to pharmaceutical sector. Here is what emerged.

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 [...]

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.

When switching to the R3 database the implementation consists also in migration and conversion of the data. It is a delicate operation that requires a path to be defined shared with the customer. Let's see how we approach thi delicate issue with SafetyDrugs 6.

Whether it comes from an Excel spreadsheet or a software, the change always raises numerous questions. So we wanted to explain what to expect during the analysis of the new product.

Many are the pharmaceutical companies that still store up pharmacovigilance data with spreadsheets. There are many reasons to leave Excel and switch to a native ICH R3 software. Here they are in detail.

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. [...]

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...

The Data Protection Officer (DPO) is a professional figure introduced by the new GDPR (General Data Protection Regulation). He/She is an expert whose duties mainly consist in monitoring compliance with the regulation, in assessing the impact on [...]

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...

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 [...]

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.

Become effective the General Data Protection Regulation, the new UE regulation. Here's the measures adopted by Max Application.

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.

We presented SafetyDrugs 6, the new native ICH R3 version of our pharmacovigilance database, to our customers. Here are the questions that arose.

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!

Three different statistical indicators, statistical significance tests, case reports from literature and much more. Here are the tools of our Business Intelligence.

SafetyDrugs has heartily participated in the donation of a car for Fondo Edo Tempia, useful for patient transport on the territory.

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

The UNI EN ISO 9001:2015 standard introduces the concept of risk-based thinking. Here what it is and what are the advantages.

EMA postpones the entry into force of the ICH R3 regulations: this is what emerged at the round table organized by Asgenia where, to the users of SafetyDrugs, Max Application explained the migration to ICH R3.

The project manager Carlo Ghiglione replies to some questions about the switch to the new rules ICH R3. Here is what is important to know.

Here is ACU, the new assistance portal that will make easier all your support requests, shortening, in this way, time for the resolution of your problems.

Drawn up in September, with the support of Colin & Partners, the new PLA (Privacy Level Agreement) introduces significant protections for data security

From 15 to 19 June 2015 has taken place a training session with Egyptian QPPV

Since 2013 SafetyDrugs is supplier of Assogenerici Furnishes high quality Pharmacovigilance services to its associated pharmaceutical companies.

Since 2013 imports and modifies your AE directly on your database using SDConverter.