In the EEA, Marketing Authorisation Holders are required to appoint a QPPV and a deputy QPPV residing in the EEA.
Selected senior Vigilex staff are able to take on these extremely demanding roles and are fully aware of the considerable responsibilities involved.
Vigilex fulfils QPPV roles for various companies based e.g. in Japan, the USA and Europe for their compliance with applicable laws and regulations, such as the pharmacovigilance rules in the European Union as set out in the Good pharmacovigilance practices (GVP) Modules.
A detailed description of the respective tasks and responsibilities of the MAH and the QPPV will be included in the agreement, allowing each party to effectively perform their respective roles.
The role of (deputy) QPPV can be fulfilled on a structural basis or for an interim period.
Vigilex also fulfils local QPPV roles in various EU countries as required by local legislation.