A History of Pharmacovigilance
Pharmacovigilance, also known as drug safety surveillance, is the process of monitoring, identifying, and assessing medicinal products’ potential risks and benefits. It is an essential part of ensuring the safety and efficacy of drugs for patients and healthcare...
Developing a Safety Management Plan (SMP) for Pharmacovigilance
Developing a Safety Management Plan (SMP) What is the Safety Management Plan (SMP)? This article explores all you need to know about the SMP for Pharmacovigilance and how you develop it. A Safety Management Plan (SMP) is a critical component of a comprehensive...
EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures?
European Medicines Agency (EMA) and Food and Drug Administration (FDA) are regulatory bodies working in Europe and the United States of America, respectively, with their own approached to risk management procedures. They both aim to promote and protect public health...
Webinar: Setting up a pharmacovigilance system in Europe. Where to start? What to consider?
Setting up a pharmacovigilance system is not as straightforward an answer as it may sound. There are many aspects to consider, which can seem complicated, especially when you must focus on developing your product. In the first part of this webinar, our experts lay out...
