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.