NEWS

CPhI: 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.

16th November 2021

Covid vaccines: this is what the data reveal after 6 months of administration

It was December 2020 when the first doses of vaccines against the Covid-19 arrived in Italy. Between doubts and perplexities, almost 50 million doses have been administered to date. Let's see what the data published by the Italian Medicines Agency (AIFA) say.

14th July 2021

Brexit and data circulation between the EU and the UK: the European Commission decision arrives

Two adequacy decisions adopted, here's what they sanction

30th June 2021

MDR and the Delegation Law: the areas to be redefined

From Post Marketing Surveillance to the GDPR, here are the government decrees for the implementation of the MDR.

23th April 2021

Collaboration between pharmacovigilance and quality: how to make it possible when the affiliates have different nature

During the AFI webinar "Pharmacovigilance and quality" on 27th November, Dr. Donata Saddemi and Dr. Barbara Belloni respectively Pharmacovigilance Manager & Regulatory Associate and QA Manager & Qualified Person of the pharmaceutical company Recipharm Italia, illustrated their complaint management flow.

18th February 2021

How to manage complaints and their impact on safety

Complaint management is a procedure that affects every company, but in the pharmaceutical field it can also have consequences on the patient's health.

4th February 2021

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”.

21st January 2021

The KPIs from the point of view of a branch

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?

7th January 2021

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.

22nd December 2020

PSMF: difficulties between global and local

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.

16th December 2020

Patient Support Programs and Market Research: their help in safety

How PSPs and MRPs can be useful from a pharmacovigilance point of view? It was discussed at the European Pharmacovigilance Congress held the 26th and27th November and of which we were sponsors.

11th December 2020

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 of the European Pharmacovigilance Congress, held online on 26th and 27th November where we were sponsors.

09th December 2020

European Pharmacovigilance Congress: here's what was talked about in 2020

This year too was held the European Pharmacovigilance Congress, arrived at his 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 held.

2nd December 2020

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.

28th October 2020

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.

16th September 2020

MDR and significant changes: here are the modifications to avoid to take advantage of the transitional period

What are the significant changes? This is one of the questions asked by the manufacturers of Class I Medical Devices that pass into a higher category. Here's what the Medical Device Coordination Group states.

17th July 2020

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.

25th June 2020

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.

19th June 2020

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) is therefore extended too. Here are the conditions to benefit of them.

27th May 2020

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.

21st aprile 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.

15th April 2020

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.

23rd January 2020

Pharmacovigilance in special populations: pregnancy and breastfeeding

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 QPPV at Italfarmaco SpA spoke about this during the European Pharmacovigilance Congress.

16th December 2019

Pharmacovigilance in special populations: pediatrics patients

How does the pharmacovigilance activity for pediatrics change? Here's what we report from the European Pharmacovigilance Congress.

13th December 2019

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.

10th December 2019

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.

6th December 2019

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 at the Starhotel Business Palace from 28 to 29 November 2019.

21st November 2019

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 fact the most frequent question is: how much does SafetyDrugs cost?

28th October 2019

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 have organized a team dedicated exclusively to the customers of SafetyDrugs: we can guarantee assistance in a short time.

27th September 2019

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. Here's how the training takes place.

30th July 2019

32nd Rally Lana, between history and innovation

The 32nd edition of the Rally Lana - Meme Gubernati Trophy was held on July 13-14, 2019, an event dear to the Biella area, headquarter of Max Application, of wich we proudly were top sponsor.

15th July 2019

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?

04th< July 2019

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 at the 59th edition of the AFI Symposium held in Rimini from 5th to 7th June.

26th June 2019

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.

20th June 2019

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 the theme "Innovation and globalization strategies for the pharmaceutical industry".

28 th May 2019

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.

23rd May 2019

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.

03rd May 2019

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.

08th April 2019

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.

14th March 2019

ICH R3: 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.

27th February 2019

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.

13th February 2019

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.

28 th January 2019

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.

08th January 2019

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

18th December 2018

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.

6th December 2018

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.

3rd December 2018

What to expect from European Pharmacovigilance Congress 2018?

We asked the organizers of the event. Here are some anticipations...

12th November 2018

GDPR: why Max Application endowed itself with a DPO

The Data Protection Officer is an optional professional figure introduced by the GDPR for the data protection and security. We have chosen to appoint an external DPO, that's why..

22nd October 2018

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.

21st September 2018

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...

05th July 2018

What is vaccinovigilance? Signal analysis and validation

During the XI session dedicated to the pharmacovigilance of the 58th AFI Symposium, Dr. Finizia spoke about the vaccines, the relative adverse events and vaccinovigilance. Here is how the analysis of the signal is articulated.

20th June 2018

What is vaccinovigilance? Adverse events following immunization (AEFI): classification and collection

After defining what vaccinovigilance is and its aims, GSK's Mrs. Finizia continued the report at the 58th AFI Symposium, focusing on vaccine reactions, called AEFI.

18th June 2018

What is vaccinovigilance? Definition and purpose

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 ...

15th June 2018

The new EudraVigilance system

The session dedicated to pharmacovigilance was held on Friday, June 8, 2018. Here's what emerged from the intervention of Mrs. Sottosanti ...

14th June 2018

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..

13th June 2018

58thAFI 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.

11th June 2018

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 how Max Application has adjust itself.

23rd May 2018

Events and initiatives: with SafetyDrugs around the world

Here are all the important events for SafetyDrugs and all the exhibitions we have been at

13th February 2018

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.

11th December 2017

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.

4th December 2017

EU PhV Day: to 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.

1st December 2017

How data security improves with SafetyDrugs 6

The Oracle Data Centre, located in Amsterdam, is the choice that Max Application made to ensure an ever higher data protection.

5th October 2017

European Pharmacovigilance Day: news on EudraVigilance

On 30th November 2017,the first edition of the European Pharmacovigilance Day will take place, which SafetyDrugs is the unique sponsor of.

31st July 2017

3 questions about SafetyDrugs 6 from our clients

The new version of SafetyDrugs will officially go out in November. We shown it in preview to our clients, that asked us three curious questions..

03rd July 2017

10 points of reflection that came up during the 57th AFI Symposium

This year too, at the conference centre of Rimini, took place the AFI Symposium. For those who would have liked to be present, we extracted ten key points about the pharmacovigilance news.

21st June 2017

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!

13rd June 2017

A lot of data for an even more efficient Signal Detection

Three different statistical indicators, statistical significance tests, reporting of cases arising from Literature and much more...

15th February 2017

A little help for a laudable reality of Biella, SafetyDrugs hometown

SafetyDrugs has heartily participated to the donation of a car for Fondo Edo Tempia, useful for patients transport on the territory

11th January 2017

FDA approves SafetyDrugs electronic transmission

Following testing of electronic exchange of ICSR with FAERS, the FDA database, SafetyDrugs has received the approval of the process in production environment

19th December 2016

A SafetyDrugs pilot winner at Rally of Monza

It is Corrado Pinzano, the pilot from Biella whom we are proudly sponsor of.

13th December 2016

3D printing: which prospects in medical field?

The technology steps toward a revolution in personalized medicine

1st December 2016

Biosimilars: a market growing 20-fold by 2020

This was one of the main topics of the CPhI we attended in Barcelona from 4 to 6 October.

2nd November 2016

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.

12th October 2016

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...

27th September 2016

EMA postpones the ICH R3 rules entry into force

It came up at the round table, organized by Asgenia, where Max Application has explained, to the SafetyDrugs users, the migration to ICH R3

7th July 2016

“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. For the clients it is important to know that…

19th May 2016

The DIA Annual Euromeeting has been an event not to be missed

DIA is the only global organization dedicated to bringing health care product development professionals to improve health throughout the world.

20th April 2016

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 your problems resolution.

29th February 2016

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

10th November 2015

Training in Egypt

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

30th June 2015

SafetyDrugs at 55th AFI simposium

SafetyDrugs & eCTD-Pharma in collaboration at 55th AFI simposium

16th June 2015

SafetyDrugs in Egypt!

SafetyDrugs is now distribuited in Egypt by APSE for I.T. Solutions.

23rd March 2015

SafetyDrugs is now Assogenerici's provider!

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

4th September 2013

SD converter

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

6th May 2013