This page shows the latest PRAC news and features for those working in and with pharma, biotech and healthcare.
In December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the treatment for abnormal bleeding in women with uterine fibroids after four cases of serious liver injury -
The 2012 reforms gave new powers to the EMA and created a Pharmacovigilance Risk Assessment Committee (PRAC) that helped to coordinate the activities of both the centralised agency and national regulatory ... Patient and healthcare professional
The PRAC has now updated recommendations for use to manage the potential problems. ... If patients suffer from a generalised infection, they should not begin treatment with Zydelig, PRAC says.
effects. The regulator's Pharmacovigilance Risk Assessment Committee (PRAC) ruled out a connection between Cervarix and Gardasil and complex regional pain syndrome (CRPS) or postural orthostatic tachycardia syndrome (POTS). ... However, the EMA's
The EMA said its pharmacovigilance risk assessment committee (PRAC) will now examine the available data on CRPS and PoTS to see whether there may be a causal link with HPV vaccination
marketing safety and efficacy studies, and created the Pharmacovigilance Risk Assessment Committee (PRAC).
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If the same safety concerns apply to more than one medicinal product, the competent authority may, following consultation with the Pharmacovigilance Risk Assessment Advisory Committee (PRAC), encourage the performance of a ... Among others activities,
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The EMA has extended the tenure of Dr June Raine as chair for its Pharmacovigilance Risk Assessment Committee (PRAC). ... Under her leadership Dr Raine said the PRAC would have three key priorities:. •
The European Medicines Agency's (EMA) newest committee - the Pharmacovigilance Risk Assessment Committee (PRAC) - has added two new members. ... Its new members Babylon and van der Zeijden will participate in the PRAC from April 2013.
MHRA's Dr June Raine to chair new EMA pharmacovigilance committee. Pharmacovigilance Risk Assessment Committee (PRAC) will lead implementation of reforms. ... The PRAC will lead implementation of the wide-ranging pharmacovigilance reforms the EMA brought
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