The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicinal product JNJ-81201887 (AAVCAGsCD59) for the treatment of geographic atrophy secondary to age-related macular degeneration. The public consultation runs from 22 March 2023 to 21 April 2023.
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Recommendations for suppliers of prescription software about the order of presentation and selection of medicinal products and non-medicinal products
The FAMHP and the NIHDI wish to remind prescription software suppliers of a number of homologation requirements for the order of presentation and selection of medicinal products and non-medicinal products.
Point of contact at authorisation holders for the supply and availability of medicinal products
The FAMHP reminds marketing authorisation holders for medicinal products for human use to register a single point of contact (i-SPOC) for the supply and availability of medicinal products through the IRIS platform of the EMA.
The FAMHP launches the Medicinal Product Management database: updating data in existing medicinal product databases temporarily not possible
On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.
Give your opinion on genetically modified vaccines to treat hepatitis B
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 vaccines ChAd155-hIi-HBV and MVA-HBV for the treatment of infections with the hepatitis B virus (HBV). The public consultation will run from 27 November 2021 to 27 December 2021.
Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP
A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.
Give your opinion on a genetically modified medicine to treat dementia
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 medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN). The public consultation will run from 28 July 2021 to 27 August 2021.
Discontinuation of the telephone contact point of the Marketing Authorisation Division (variations and renewals)
The telephone contact point of the Marketing Authorisation Division (variations and renewals) will be discontinued as of Friday 16 July 2021. The division can still be contacted by email.
First information session on the new Clinical Trial Regulation (CTR) on 23 September 2021
The FAMHP is organising two information sessions on 23 September 2021 and 25 November 2021 for sponsors and applicants of clinical trials about the new Clinical Trial Regulation (CTR). The first information session will take place virtually on 23 September 2021 from 9 a.m. to 12:30 p.m.
The FAMHP organises two information sessions on the new Clinical Trial Regulation (CTR)
FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 25 November 2021 on the new Clinical Trial Regulation (CTR).