The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action, funding by the Consumers, Health and Food Executive Agency (CHAFEA), ran from 2013 to 2016. SCOPE was created to support pharmacovigilance operations in Europe following new requirements introduced by the European pharmacovigilance legislation of June 2012.
SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems. Using this information, a variety of tools were developed including guidance documents, pharmacovigilance training materials and other tools to support best practice. The Joint Action supports consistent pharmacovigilance operations approaches throughout the EU network, benefiting the safety monitoring of medicines and communication outputs, thereby helping to safeguard public health.
SCOPE consisted of eight work packages, three of which focused on practical aspects of the project - coordination, dissemination and evaluation. The other five work packages were associated to specific pharmacovigilance topics of Adverse Drug Reaction (ADR) collection, signal management, risk communication, quality management systems and lifecycle pharmacovigilance.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) was the Joint Action coordinator, and was responsible the coordination and dissemination work packages.
Information about SCOPE is also available in a printable leaflet format.