Current state of biologic pharmacovigilance in the European Union: improvements are needed

T Felix, JB Jordan, C Akers, B Patel… - Expert opinion on drug …, 2019 - Taylor & Francis
Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized
medicines. Compared with small-molecule drugs, biological drugs are more complex, more …

Solving the Continual Improvement and Innovation Challenge for the Benefit of Patients: How an Effective Pharmaceutical Quality System (PQS) and Risk-Based …

E Ramnarine - 2021 - arrow.tudublin.ie
Patients deserve their medicines on time every time. Regulators safeguard public health by
ensuring availability of safe, effective, high-quality medicines. Pharmaceutical companies …