It appears that Europeans are interested in further investigating the development of inhibitors in response to different classes of Factor concentrates (Recombinant vs Plasma -derived).
The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines. According to the EMA website the responsibility of PRAC is
"to prepare recommendations on any questions relating to pharmacovigilance activities related to a medicine for human use and on risk-management systems, including the monitoring of the effectiveness of those risk-management systems."
I think of PRAC in the EU as an equivalent of MASAC in the US. PRAC met in early July, 2016 and has provided the meeting highlights. Here they provide a timeline of their procedure and also and opportunity for public hearings to hear the EU citizen's voice.
There is also a response from the United Kingdom Haemophilia Center Doctors' Organization (UKHCDO). Their jurisdiction is England, Scotland, Northern Ireland and Wales. UKHCDO released a statement on the SIPPET study. The statement concludes:
"Pragmatically, UK clinicians should counsel parents about the implications of known inhibitor studies if the presenting clinical scenario allows. Recombinant FVIII concentrates remain an acceptable standard of care for PUPs, with plasma-derived concentrates considered on an individualized basis."
The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines. According to the EMA website the responsibility of PRAC is
"to prepare recommendations on any questions relating to pharmacovigilance activities related to a medicine for human use and on risk-management systems, including the monitoring of the effectiveness of those risk-management systems."
I think of PRAC in the EU as an equivalent of MASAC in the US. PRAC met in early July, 2016 and has provided the meeting highlights. Here they provide a timeline of their procedure and also and opportunity for public hearings to hear the EU citizen's voice.
There is also a response from the United Kingdom Haemophilia Center Doctors' Organization (UKHCDO). Their jurisdiction is England, Scotland, Northern Ireland and Wales. UKHCDO released a statement on the SIPPET study. The statement concludes:
"Pragmatically, UK clinicians should counsel parents about the implications of known inhibitor studies if the presenting clinical scenario allows. Recombinant FVIII concentrates remain an acceptable standard of care for PUPs, with plasma-derived concentrates considered on an individualized basis."
