The theme of the session dedicated to pharmacovigilance of the 61st edition of the AFI Symposium was risk management in all its facets, including the information material, which Dr. Cagnato of DOC Generici spoke about in her speech. Here's what emerged.
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.
Juggling architectural barriers and various obstacles will no longer be a problem for people in wheelchairs, thanks to the Open Social Navigator.
After Brexit there were numerous the doubts regarding the data protection system in the United Kingdom: 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.
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.
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.
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.
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”.
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?
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.
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.