With the study of pre-authorised medicines usually limited to the relatively small number of patients covered during clinical trials, it is essential that once a medicine receives its marketing authorisation, the monitoring process continues throughout its lifecycle to ensure the benefit-risk remains appropriate and any adverse drug reactions are reported and acted on appropriately.
How can we help?
Our pharmacovigilance experts can help you to ensure that you are fully compliant and adhering to Good Pharmacovigilance Practice (GVP) in the EU. They can advise and assist with everything from monitoring spontaneous adverse drug reactions and carrying out routine literature searches, to submitting Periodic Safety Update Reports (PSURs) and providing system set up and preparation of Pharmacovigilance System Master Files (PSMF). We also support post-marketing pharmacovigilance activities outside the EU.
Another key requirement of the EU legislation is the stipulation that, without exception, a Qualified Person for Pharmacovigilance (QPPV) must be appointed to oversee the pharmacovigilance services for authorised products held by your company. The appointment of a QPPV (who must be resident in the European Economic Area) is a legal requirement and can be contracted out. We have appropriately qualified and experienced consultants who can carry out this role on your behalf as well as acting as local contact persons for pharmacovigilance in EU Member States.
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION