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PRAC December 2021 – Assessment of recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax

During the December 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax.

Second information session on the new Clinical Trial Regulation (CTR) on 15 December 2021

The FAMHP is organising the second information session on the new Clinical Trial Regulation (CTR) for sponsors and applicants of clinical trials on 15 December 2021 from 9 a.m. to 12 noon. The presentation and questions and answers of the first info session are now available.

Procedure for removal or addition of a patented indication for medicines for human use

The applicant or marketing authorisation holder for a generic medicine may decide not to include the patented indications or dosage forms in the marketing authorisation and not to mention them in the summary of product characteristics and package leaflet. Applicants/marketing authorisation holders must follow specific procedures to remove or reinsert the patented indication.

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.

Clinical Trials Regulation (CTR): specific webinar for small and medium-sized enterprises (SMEs) and academic sponsors

In the context of the preparation of the implementation of the Clinical Trials Regulation (CTR), which will come into force on 31 January 2022, a specific webinar for SMEs and academic sponsors on key aspects of the CTR and the new processes via the Clinical Trials Information System (CTIS) for clinical trial application submissions will be organised on 29 November 2021.

Coronavirus: updated timelines for applications for COVID-19 clinical trials

Since 25 March 2020, shortened deadlines have been used for applications for clinical trials with medicinal products for the treatment or prevention of COVID-19. As the vaccination campaign has reached the majority of the population, these reduced timelines are extended to 15 calendar days.

Deadlines for the submission of dossiers during end-of-year period

During the end-of-year period, the FAMHP will be closed from Monday 27 December 2021 through Friday 31 December 2021. Deadlines have been set for the submission of different types of dossiers.

PRAC November 2021: updates on COVID-19 vaccines and conclusion of safety signal for Imbruvica

During its November 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has made un update on COVID-19 vaccines and concluded a safety signal for Imbruvica.

Give your opinion on a genetically modified vaccine to treat colorectal cancer

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 vaccine VSV-GP128 to treat colorectal cancer. The public consultation will run from 1 November 2021 to 1 December 2021.

PRAC October 2021 – Nomegestrol containing products and chlormadinone containing products and update on COVID-19 vaccines

During its October 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of meningioma risk with nomegestrol- and chlormadinone-containing medicines. The PRAC also has reviewed data on venous thromboembolism and immune thrombocytopenia with COVID-19 vaccines.

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