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 | Oct 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 | Oct 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...
by Nick | Aug 22, 2022 | Pharmacovigilance
Pharmacovigilance is the process of monitoring the safety and effectiveness of medications. The term was introduced in the early 1970s and evolved to include a broader range of activities. It’s vital to ensure that patients have access to safe and effective...
by Nick | Jul 7, 2022 | Pharmacovigilance
Automation & AI in Pharmacovigilance: Promises and Realistic Expectations Recent years have seen increasing pharmaceutical companies’ pharmacovigilance (PV)-related activities. The promise of artificial intelligence (AI) and automation is often mentioned as...
