In accordance with the European regulation on pharmacovigilance, the marketing authorization holders (MAH) must periodically review the internet (digital media, under their management or responsibility) in order to look for potential cases of suspected adverse reactions of their medicinal products. The main dilemma is how to search and validate these cases in a big network of global information such as the Internet.
The aim of the session is to offer the tools and procedures for the search of cases of adverse reactions on the internet and at the same time its integration in the pharmacovigilance system of the MAH. During the session we will share practical examples and best practices, i.e. how to cover, analyze and validate all the safety information of medicines available on the Internet (social networks, chats, forums, websites, blogs, etc) as well as procedures and processes that must be developed to adapt the MAH pharmacovigilance system.
Biochemist. PhD in Biochemistry. Academic Research in molecular neurobiology and molecular mechanisms of cardiovascular diseases. Senior Drug Safety Officer at Asphalion since 2013 working in PhV system services: Spanish local contact affairs, Deputy EU QPPv, safety databases (PcVmanager), Pharmacovigilance (PV) agreements review, PSMF/PV-SOP designing and writing, ICSRs management and submission, xEVMPD, local literature searches and preparation of PSURs/Addendum/Bridging reports/Risk management plan.
Pharmacist. Master in Safety of Medicine: Pharmacovigilance and Studies Post-Autorization. Experience in Pharmacovigilance: 19 years. Management and coordination of Scientific Committee of Pharmacovigilance of the Spanish Association of Industry Pharmacists (AEFI) (2000 up to now). Collaboration with the Spanish Competent Authorities for the elaboration of Good Pharmacovigilance Practices. Professor/trainer in Pharmacovigilance courses/congress/symposiums (2010 up to now). She joined Asphalion: 2014
Professional experience and roles:
Acting as EU-QPPV and local QPPV as a service for third-party companies and in previous industry positions
Expert in auditing, creation and maintenance of PV Quality Systems, PV training, case management, PSUR and PSMF elaboration, Review and elaboration of PV Agreements.