How to choose a safety database: the definitive guide
Here are the best features to look for understand how to choose a safety database
Why a safety database is convenient for pharmaceutical companies?
A safety database is a fundamental tool for complying with pharmacovigilance regulations, allowing you to save time and resources. Here it is the reasons why a safety database is convenient for pharmaceutical companies.
Clinical trials: Italian National Ethics Committees are operative now
The two Italian National Ethics Committees for clinical trials will evaluate the study protocols of their respective competencies on a monthly basis.
Drug shortages: the app for notifying patients is now available
Citizens can now always be updated on any shortages of medicines thanks to AIFA Medicinali.
Pharmacovigilance: how it works
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.
Rally della Lana 2022
The Rally della Lana is approaching its 35th edition. The 7 special stages will be held in the Biella area from 29 to 30 July 2022.
Educational material: the point of view of the pharmaceutical company and the patient
Educational material was a topic addressed in the Pharmacovigilance session of the 61st AFI Symposium. Here's what emerged.
AIFA: new italian National Pharmacovigilance Network coming soon
AIFA is ready! The Italian Medicines Agency has announced that the new Italian National Pharmacovigilance Network will be available.
Risk management and educational material as aMMR
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.
AFI Symposium 2022: the vigilance at 360°
As per tradition, the AFI Symposium dedicated a session entirely aimed at pharmacovigilance. Here's what emerged.
61st AFI Symposium: the program
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.
EDQM standard terms: mandatory for Dosage Forms and Route of Administration
The EDQM standard terms will be mandatory starting for the indication of dosage forms and routes of administration in pharmacovigilance reports. Here's the news.
Drug shortages: the measures for EMA to tackle them
Thanks to an EU Regulation, the European Medicines Agency has now the means to strengthen the tools against shortages of medicines and medical devices. Here are all the news.
Disability and accessible routes: here is WeGlad, the app to freely move
Juggling architectural barriers and various obstacles will no longer be a problem for people in wheelchairs, thanks to the Open Social Navigator.
CPhI Worldwide: the balance of the 2021 edition
The 30th edition of one of the most important events for the pharmaceutical sector was held at Fiera Milano. We were there, here's how did it go.
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.
Data flow from EU to UK: the European Commission decision arrives
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.
MDR: applicability is official, is everything ready?
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: the main news
The MDR, which replaces the old Directive, implements several new features. Here they are.
MDR and the Delegation Law: the areas to be redefined
rom Post Marketing Surveillance to the GDPR, here are the government decrees for the implementation of the MDR.
MDR and manufacturer’s information: all the news
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.
Complaint management: example of collaboration between pharmacovigilance and quality
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.
How to manage complaints in the pharmaceutical field
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.
KPIs as a tool for relationships between global and local
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”.
Quality: how to manage it in the absence of personnel
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?
Pharmacovigilance and quality: from KPIs to complaint management
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.
PSMF: extra EU management
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.
Patient Support Programs and Market Research Programs: their help in pharmacovigilance
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.
How much important the communication in pharmaceutical is?
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 [...]
European Pharmacovigilance Congress: here’s what was talked about in 2020
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.
MDR Post market surveillance: manufacturers requirements and obligations
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.
Medical Devices Regulation: what UDI is
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.
MDR and significant changes: here are the modifications to avoid to take advantage of the transitional period
Here is the list of all significant and non-significant changes and dos and don'ts to take advantage of the transition period of the MDR.
Covid-19: here’s how the emergency impacted on Italian pharmacovigilance
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.
Medical devices and declaration of conformity: the 10 requirements for its validity
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 [...]
Medical devices regulation: the requirements to take advantage of the transitional period
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) [...]
MDR (Medical Device Regulation): the postponement is official
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.
Coronavirus forces MedDRA 23.0 to an unexpected urgent update
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.
EMA: from 30 June 2022 the ICH E2B (R3) becomes mandatory
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.
Farmacovigilanza in special population: gravidanza e allattamento
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 [...]
Pharmacovigilance in special populations: pediatrics patients
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 [...]
Pharmacovigilance in special populations: geriatric patients
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.
European Pharmacovigilance Congress: what we take home from the third edition
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 [...]
In Milan, the third edition of the European Pharmacovigilance Congress
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 [...]
How much does SafetyDrugs cost?
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 [...]
How the SafetyDrugs assistance service works
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 [...]
Learn to use the ICH R3 database in four days
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 [...]
Medical devices: marketing authorization in USA and China
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?
Medical devices: 26th May 2020, a likely date?
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 [...]
Medical devices and safety: what will change with the new rules
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.
59th AFI Symposium: pharmacovigilance meetings not to be missed
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 [...]
Simple database validation with our help
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
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.
Find out if SafetyDrugs is the most suitable ICH R3 database for you
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.
ICH R3: why an Excel sheet is not the best choice for ADRs managing
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.
Safety databse implementation: how long does it take to integrate SafetyDrugs into business processes?
This is a frequently asked question when a company is considering changing the old database with a native ICH R3 one. Here are the phases and times of integration of SafetyDrugs 6.
EudraVigilance, inspections and non-compliance: here is what to pay attention to
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. [...]
DIA Europe 2019: the conference agenda on pharmacovigilance
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.
Pharmacovigilance in the age of social media
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.
Too many duplicates? 8 tips to avoid them
Here are some valuable suggestions provided by Calin Lungu during the European Pharmacovigilance Congress on the management of duplicates.
Brexit, privacy, social media and other themes mentioned at the EU PhV Congress 2018
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.
What is the mood of the sector one year after the ICH R3?
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.
What to expect from European Pharmacovigilance Congress 2018?
We asked the organizers of the event. Here are some anticipations...
GDPR: why Max Application endowed itself with a DPO
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 of ICH R3: it is discussed at the European Pharmacovigilance Congress
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.
3 functions of SafetyDrugs the pharmacovigilance operator likes
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...
What is vaccinovigilance? Definition and purpose (1/3)
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.
What is vaccinovigilance? Signal analysis and validation (3/3)
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 EudraVigilance system and the Italian adaptation
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.
What is vaccinovigilance? Adverse events following immunization (AEFI): classification and collection (2/3)
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
Inspective activities by AIFA (Italian national Agency)
"The new horizons of pharmacovigilance in Italy and Europe" was the session dedicated to pharmacovigilance held on Friday afternoon at the 58th AFI Symposium.
58th AFI Symposium: innovation in pharmaceutical sector
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.
7 technical and organizational measures to comply with the EU GDPR – General Data Protection Regulation
Become effective the General Data Protection Regulation, the new UE regulation. Here's the measures adopted by Max Application.
5 things to remember from the European PharmacoVigilance Day 2017
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.
EU PhV Day: the Business Intelligence and ICH R3 rules
During the European PharmacoVigilance Day on 30th November 2017, Mr Garlanda of Max Application introduced the analyses with SafetyDrugs 6.
EU PhV Day: be compliant with worldwide pharmacovigilance standards
The European PharmacoVigilance Day took place in Milan, the event where Mr Ghiglione revealed some news about SafetyDrugs 6.
3 questions about SafetyDrugs 6 from our clients
We presented SafetyDrugs 6, the new native ICH R3 version of our pharmacovigilance database, to our customers. Here are the questions that arose.
10 points of reflection that came up during the 57th AFI Symposium
From 7th to 9th June 2017 took place the 57th edition af AFI Symposium. Here are ten aspects raised during the seminars.
Pharmacovigilance defines new standards
SafetyDrugs, the pharmacovigilance software made in Italy, is preparing itself for the new parameters. Here are some of the news that await you!
A lot of data for an even more efficient Signal Detection
Three different statistical indicators, statistical significance tests, case reports from literature and much more. Here are the tools of our Business Intelligence.
A little help for a laudable reality of Biella, SafetyDrugs hometown
SafetyDrugs has heartily participated in the donation of a car for Fondo Edo Tempia, useful for patient transport on the territory.
3D printing: which prospects in medical field?
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: a market growing 20-fold by 2020
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.
Why to pay for somenthing that you don’t use? Choose SaaS!
Pharmacovigilance becomes accessible to everybody with Saas! Enjoy the on-cloud service, set it up and pay just for your real demands.
What does it changes with the UNI EN ISO 9001:2015 certification?
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 ICH R3 rules entry into force
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.
“With SafetyDrugs 6.0 you choose when to switch to new 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.
Assistance request easier and faster with ACU
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.
How changes the treatment of the sensitive data with the new PLA
Drawn up in September, with the support of Colin & Partners, the new PLA (Privacy Level Agreement) introduces significant protections for data security
SafetyDrugs is now Assogenerici’s provider!
Since 2013 SafetyDrugs is supplier of Assogenerici Furnishes high quality Pharmacovigilance services to its associated pharmaceutical companies.
SD Collection is the annual SafetyDrugs magazine with all the pharmacovigilance news