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Who is a Qualified Person (QP)? A Guide to the ...
Find out who the pharmaceutical Qualified Person (QP) is, their legal responsibilities (Directive 2001/83) and the requirements (degree, experience) to become one.
Who is a Qualified Person (QP)? A Guide to the ...
Find out who the pharmaceutical Qualified Person (QP) is, their legal responsibilities (Directive 2001/83) and the requirements (degree, experience) to become one.
Technological Innovations in Pharmacovigilance:...
European pharmacovigilance is undergoing a transformation thanks to new technologies: updates to EudraVigilance, the introduction of the Product Management Service (PMS), and the first EMA guidelines for the use of...
Technological Innovations in Pharmacovigilance:...
European pharmacovigilance is undergoing a transformation thanks to new technologies: updates to EudraVigilance, the introduction of the Product Management Service (PMS), and the first EMA guidelines for the use of...
Pharmacovigilance: Updates on risk minimization...
The third revision of Module XVI of Good Pharmacovigilance Practices (GVP) came into force in August 2024. Learn what's new, the impact on pharmaceutical companies, and how to adapt internal...
Pharmacovigilance: Updates on risk minimization...
The third revision of Module XVI of Good Pharmacovigilance Practices (GVP) came into force in August 2024. Learn what's new, the impact on pharmaceutical companies, and how to adapt internal...
Drug Traceability and Serialization: From the E...
Pharmaceutical traceability is now a global priority. From the European Anti-Falser Directive (DMF) to the US Drug Supply Chain Security Act (DSCSA), companies must adapt their serialization and track &...
Drug Traceability and Serialization: From the E...
Pharmaceutical traceability is now a global priority. From the European Anti-Falser Directive (DMF) to the US Drug Supply Chain Security Act (DSCSA), companies must adapt their serialization and track &...
EU pharmaceutical law reform: what's changing a...
In 2023, the European Commission presented a proposal to reform pharmaceutical regulations, intended to transform access to medicines and the rules for companies in the sector. Discover the key objectives,...
EU pharmaceutical law reform: what's changing a...
In 2023, the European Commission presented a proposal to reform pharmaceutical regulations, intended to transform access to medicines and the rules for companies in the sector. Discover the key objectives,...
CSA vs. CSV: FDA's New Approach to Computerized...
The FDA is proposing a paradigm shift: less bureaucracy and more critical thinking in the validation of computerized systems. Learn the differences between CSA and CSV and how to prepare...
CSA vs. CSV: FDA's New Approach to Computerized...
The FDA is proposing a paradigm shift: less bureaucracy and more critical thinking in the validation of computerized systems. Learn the differences between CSA and CSV and how to prepare...