EMA

European Medicines Agency and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launch 'ENCePP studies'

On 8 June 2010 the European Medicines Agency and the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launched 'ENCePP studies'. Building on the foundations of the ENCePP network of Excellence, 'ENCePP studies' is a seal for EU-based, benefit/risk or risk studies that are carried out in compliance with the ENCePP code of conduct for independence and transparency and its methodological research standards and are entered into a publicly available electronic register before their start.

New certification procedure designed to help small and medium-sized enterprises developing innovative medicines

The European Medicines Agency's Committee for Advanced Therapies (CAT) adopted the first opinion on the certification of experimental data generated for an advanced therapies medicinal product (ATMP) under development by a small and medium-sized enterprise (SME).

New Visual identity of the European Medicines Agency

The Agency unveiled its new visual identity on 8 December 2009. The new identity was developed primarily to ensure that the communications materials of the Agency are based on professionally designed templates, and created with a consistent look and feel. Communication with the public is an important aspect of the Agency's work, a second objective for developing the new visual identity was to ensure that the Agency's materials communicate to the public a clearer message about its role and activities.

European Medicines Agency advises of risk of fever in young children following vaccination with Pandemrix

The European Medicines Agency is warning that young children may experience fever after their second dose of the pandemic influenza vaccine Pandemrix. Prescribers and parents should monitor the temperature of the vaccinated child and, if necessary, take measures to lower the fever (e.g. giving an antipyretic such as paracetamol). However, the Agency noted that the second dose increases the immune response against pandemic influenza.

EMEA makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents

The European Medicines Agency (EMEA) has adopted a set of recommendations aimed at minimising the risk of nephrogenic systemic fibrosis (NSF) with gadolinium-containing contrast agents in patients at risk of developing the condition. Gadolinium-containing contrast agents are used in patients undergoing magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) scans.

European Medicines Agency 2009 mid-year report shows it is still on target, despite influenza pandemic activities

The European Medicines Agency is performing on target despite the increase of activities relating to the influenza pandemic. This was the message given by the Agency's Executive Director, Thomas Lönngren, when he presented the mid-year report to the Management Board at its meeting on 1 October 2009.

European Medicines Agency implements internal reorganisation

The European Medicines Agency has begun implementing a series of changes to its internal organisation aimed at improving the functioning of the Agency and the way in which it delivers its core tasks. The changes will be introduced gradually from September to December 2009.

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