Healixia News - page 36

October 8, 2020

IFAPP Today newsletter

Source: IFAPP

Please find here the link to the IFAPP TODAY newsletter of October 2020.

October 8, 2020

Central traceability register: the traceability of certain implants to become compulsory

Source: FAMHP

From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.

October 8, 2020

Coronavirus: EMA starts first rolling reviews of COVID-19 vaccines

Source: FAMHP

EMA’s human medicines committee (CHMP), in which the FAMHP takes part, has started the first ‘rolling reviews’ of COVID-19 vaccines. The review concerns the vaccine developed by AstraZeneca and the University of Oxford and the vaccine developed by BioNTech and Pfizer.

October 6, 2020

Coronavirus – a new validation procedure for serological tests

Source: FAMHP

In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.

October 6, 2020

Influenza vaccine: people over 50 can obtain vaccine from a pharmacy without a prior prescription.

Source: FAMHP

Griepvaccin: 50-plussers kunnen zonder voorafgaand voorschrift vaccin halen bij de apotheek

Vaccin contre la grippe : les personnes de 50 ans et plus peuvent se faire délivrer le vaccin sans prescription préalable en pharmacie

October 1, 2020

TOPRA Symposium 2020 - The evolving world of Regulatory Affairs: innovate regulation or regulate innovation?

Source: FAMHP

How can health authorities such as the Federal Agency for Medicines and Health Products (FAMHP) and the European Medicines Agency (EMA), in collaboration with all stakeholders, regulate innovative medicines and health products and innovate regulations? Find out all about it at the 17th TOPRA symposium, where innovation is central and which will take place from 5 to 8 October 2020. This symposium is organized in collaboration with the FAMHP.

September 29, 2020

Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

Source: FAMHP

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

September 29, 2020

Give your opinion on a genetically modified drug for the treatment of Duchenne muscular dystrophy

Source: FAMHP

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug PF-06939926 for the treatment of Duchenne muscular dystrophy. The public consultation will run from 23 September 2020 to 23 October 2020.

September 29, 2020

Coronavirus: at-home antibody tests are no longer banned, but the FAMHP warns against misinterpreting the result

Source: FAMHP

The sale of at-home tests detecting antibodies against the new coronavirus (SARS-CoV-2) will no longer be prohibited as of 19 September 2020. However, the FAMHP warns users that there are still significant reservations about the accuracy of both negative and positive results. These at-home tests may give users a false sense of security or cause them unnecessary anxiety.

September 18, 2020

New edition VIG-news available

Source: FAMHP

Nieuwe editie VIG-news beschikbaar.

Nouvelle édition VIG-news disponible.