In Europe in 2012, new legislation for pharmacovigilance was implemented which expanded on and clarified previous legislation. New Regulation no. 1235/2010 and Directive 2010/84/EU were published and underpinned by the EC Implementing Measures Regulation no. 520/2012. In addition a series of 16 modules on GVP were developed by the EMA to guide marketing authorisation holders on the implementation of the new legislation. The basis of the new regulations is that quality systems should form an integral part of the pharmacovigilance system to ensure effective monitoring of compliance and the accurate and proper documentation of all measure taken. The ultimate objective is the protection of patients.

We aim to provide a comprehensive PV service, including a Qualified Person for Pharmacovigilance (QPPV) which can be tailored to suit individual companies’ needs. Our team is able to undertake your whole pharmacovigilance requirements or alternatively perform any specific task where your company may have a temporary lack of resource due to increased workload or vacancies.

We are able to offer a range of services including the following:

• Risk Management plans

• Collection and follow-up of spontaneous adverse drug reactions (ADRs) received on behalf of the Marketing Authorisation Holder

• Routine literature searching to identify potential adverse events related to the Marketing Authorisations Holder’s products

• Electronic management of ADRs

• Expedited reporting to Health Authorities

• Signal detection

• Preparation and submission of Periodic Safety Update Reports

 

For more information please contact us at: enquiries@pharmafile.ie