Newsroom EN2022-02-03T11:18:46+01:00

61st AFI Symposium: the program

24 May 2022|

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.

MDR: applicability is official, is everything ready?

26 May 2021|

From today, the MDR, the new European Regulation on Medical Devices, that came into force in May 2017, has full applicability. After a one-year postponement due to Covid, it wonders how the various actors involved in the fulfilment of the new duties required by EU Regulation 2017/745 are.

MDR and manufacturer’s information: all the news

23 March 2021|

With the entry into force of the MDR there are several areas that have been revised as they are treated more roughly in the old Directive, among these there are also the information supplied with the device: in order to present the correct use of your device , each manufacturer is in fact required to affix on labels, packaging and instructions for use, all the information necessary for its use, such as the risks and benefits, operating methods, CE mark, etc. Let's see the updates.

PSMF: extra EU management

16 December 2020|

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.

Pharmacovigilance in special populations: geriatric patients

10 December 2019|

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.

How much does SafetyDrugs cost?

28 October 2019|

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 [...]

Simple database validation with our help

23 May 2019|

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.

Here’s how we safely convert your data into R3

3 May 2019|

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.

Pharmacovigilance in the age of social media

8 January 2019|

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.

What is the mood of the sector one year after the ICH R3?

3 December 2018|

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.

GDPR: why Max Application endowed itself with a DPO

22 October 2018|

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 [...]

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