Drug safety or pharmacovigilance (PV) rules are necessary for the protection of public health in order to assess, detect and prevent side-effects (adverse events or adverse reactions), as the full safety profile of medicinal products can only be known after they have been placed on the market. It is both a legal and ethical requirement for companies to document, analyse and report information about the safety of their medicinal products.
Any person employed directly by a pharmaceutical company or contracted to work for the company has a responsibility to report information about the safety of the company’s medicinal products to the company’s PV department.
Companies must provide training to all employees and agents on their processes for reporting safety information, so they know what to do if they become aware of a safety concern.
New pharmacovigilance legislation was approved in Europe in late 2010, which has been in force since July 2012. In order to support companies with compliance, the ABPI Pharmacovigilance Expert Network has updated the 2011 ‘Guidelines for collection of adverse events for company representatives’ in light of the new legislation.
The updated version has been revised to be consistent with the new legislation, re-organised to improve clarity and has an updated title to reflect the larger group of company employees that should be aware of adverse event collection. The title of the new guidance has been updated to ‘Guidance notes on collection of safety information by employees and agents of pharmaceutical companies’ to reflect the changes, link to updated guidance.
You can download the full guidance document here.
Head of Regulatory Affairs