By FDA – Press releases
Ensuring the safety of medicines is a fundamental responsibility of every Marketing Authorisation Holder (MAH). According to European regulations, a robust pharmacovigilance system must be in place, which requires the appointment of a European Union Qualified Person for Pharmacovigilance (EU QPPV). In addition, certain local authorities have chosen to maintain their own regulations, resulting in the requirement for a Local Contact Person for Pharmacovigilance (LPPV).
Setting up a pharmacovigilance system can be a challenging undertaking, depending on the country in which the product is to be marketed. In order to provide support and guidance on these different regulations,the following topics will be covered in this webinar