Healixia News - page 9

June 7, 2022

Request to marketing authorisation holders to send the approved version of the risk management plan

The Vigilance Division of the FAMHP requests marketing authorisation holders to send the approved version of the risk management plan for medicinal products for human use with a national marketing authorisation.

Source: FAMHP

June 2, 2022

IFAPP Today newsletter - June 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of June 2022.

June 2, 2022

Coronavirus: monthly update of COVID-19 vaccines 2 June 2022

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 2 juni 2022

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 2 juin 2022

Source: FAMHP

June 2, 2022

Update on the safety notifications about CPAP, BiPAP and ventilator devices manufactured by Philips

Extensive analyses of Philips' CPAP, BiPAP and ventilator devices have not revealed toxicologically relevant levels of volatile organic compounds. Nevertheless, no risk can be excluded at this time: patients are advised to consult their physician about the further course of their treatment.

Source: FAMHP

May 24, 2022

Coronavirus: the Belgian guideline for the management of clinical trials during the coronavirus pandemic no longer applies

Due to the ending of the epidemiological emergency situation on 10 March 2022, the Belgian guideline to assist sponsors in the management of clinical trials during the coronavirus pandemic no longer applies. From now on, the rules in force will be applied and any deviation must be requested by providing a clear description of the situation.

Source: FAMHP

May 18, 2022

New antimicrobial drugs available in Belgium: Colistineb, Zerbaxa, Broxil and Rukobia. Important for patients and for the fight against antimicrobial resistance.

De beschikbaarheid van geschikte antimicrobiële middelen zorgt ervoor dat artsen meer mogelijkheden hebben om de beste behandeling te voorzien voor hun patiënten. Het is ook belangrijk in de strijd tegen antimicrobiële resistentie. Colistineb, Zerbaxa, Broxil en Rukobia zijn antimicrobiële geneesmiddelen die recent beschikbaar werden in België.

La disponibilité des médicaments antimicrobiens appropriés donne aux médecins davantage de possibilités de fournir le meilleur traitement à leurs patients. Elle est également importante dans la lutte contre la résistance aux antimicrobiens. Colistineb, Zerbaxa, Broxil et Rukobia sont des médicaments antimicrobiens qui ont récemment été mis sur le marché en Belgique.

Source: FAMHP

May 17, 2022

Call for tender by the European Commission: reservation of manufacturing capacities and priority right to manufacture vaccines

The European Commission has launched a call for tender to conclude single (consortium) framework contracts to reserve manufacturing capacities and obtain a priority right to manufacture vaccines in case of a future public health emergency. The project is called EU FAB.

Source: FAMHP

May 16, 2022

PRAC May 2022 – Discussion regarding a direct healthcare professional communication (DHPC) containing important information for Defitelio

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio.

Source: FAMHP

May 12, 2022

Online training: Managing and reporting serious breaches of the EU Clinical Trial Regulation

New Online Training from Brookwood Global, on demand.
Do it anywhere! Log in at any time 24/7, 365 days a year.

May 6, 2022

IFAPP Today newsletter - May 2022

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of May 2022, in which Healixia is featured!