by Nick | Dec 20, 2022 | 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...
by Nick | Dec 9, 2022 | 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...
by Kamile Gruduls | Dec 8, 2022 | Pharmacovigilance
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...
by Kamile Gruduls | Nov 30, 2022 | Pharmacovigilance, Webinar
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...
by Nick | Nov 25, 2022 | Pharmacovigilance, Regulatory Affairs
Regulatory Intelligence is a reliable and invaluable tool when it comes to pharmacovigilance. It’s so important because it allows companies to remain up-to-date with the most recent drug safety data and identify new information quickly. What Is Regulatory...
by Nick | Nov 11, 2022 | Pharmacovigilance
The EU changes on the regulatory side have been significant. It has not only seen pharma companies face a new challenge to meet the requirements but also regulated medicinal products manufacturers, distributors and Pharmacovigilance professionals. The Local Person for...
