The ABPI Pharmacovigilance Expert Network and the British Healthcare Business Intelligence Association (BHBIA) have updated the 2009 ‘Guidance notes on the collection of adverse events and product complaints from market research programmes’ in light of new pharmacovigilance legislation.
Market research is widely used to generate understanding and knowledge about a marketplace and consumer behaviour within it and careful attention to company processes and legal requirements are necessary for successful engagement in this area. This is especially important because of the potential generation of safety (or quality) information which companies have a legal obligation to monitor, collect and manage.
New pharmacovigilance legislation was approved in Europe in late 2010, which has been implemented since July 2012. To support companies with compliance, the ABPI Pharmacovigilance Expert Network and the BHBIA have updated the 2009 ‘Guidance notes on the collection of adverse events and product complaints from market research programmes’ in light of the new legislation. Download the guidance document here.
The updated version has been revised to be consistent with the new legislation and re-organised and expanded to improve clarity, although the overall requirements remain largely unchanged.
For further information, please contact me (email: [email protected]).
Dr Esteban Herrero-MartinezHead of Regulatory Affairs