The European Risk Management Strategy aims to conduct pharmacovigilance through measures allowing the early detection, assessment, minimisation and communication of risks of medicines in Europe during their life cycle.
For the work programme 2008-2009 the foremost priorities are:
improving the operation of the EU Pharmacovigilance System,
enhancing the scientific methodology underpinning the safety monitoring of medicines for human use.
Furthermore, other key issues are taken into account relate to:
introducing functionalities to further develop the EudraVigilance system,
improving the EU Regulatory System Network,
endorsing operational and scientific quality assurance,
increasing transparency on the safety of medicines,
implementing the European Network of centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
examining methodologies in the conduct of pharmacovigilance.
Last but not least, the work programme will give emphasis to a number of environmental changes having an impact on the ERMS, such as the Strategy to better protect public health by strengthening and rationalising EU Pharmacovigilance and the EU Regulation on paediatric medicines.
For further information
Two-Year Work Programme (2008-2009) implementing the Action Plan
EPHA related articles
EMEA kicks off the implementation process of the Paediatric Regulation
EMEA guidelines on pharmacovigilance for paediatric medicines - EFA’s comments
**Updated** EMEA improves provision of information for patients and consumers
**Updated**EMEA/CHMO working group with patients’ organisations, 2006
EMEA working party with patients and consumers’ organisations, 2007
