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 [...]
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 [...]
Medical devices regulation: the requirements to take advantage of the transitional period
In April 2020, the full application of the new [...]
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.