Regulatory Intelligence.
Complete monitoring and assessment service.

What is pharmacovigilance Regulatory Intelligence?

Regulatory Intelligence within pharmacovigilance refers to the collection and analysis of publicly available regulatory information, and assessing any immediate or future impact that might have on medicinal products which are in development or are already on the market.

The regulatory landscape is in a constant state of flux, both at the European Medicines Agency (EMA) and the national authority levels. Staying well informed about any regulatory shifts or other changes and information, and their potential ramifications, is a fundamental aspect of pharmacovigilance operations and the requirement to stay compliant under Good Pharmacovigilance Practices (GVP) guidelines.

Click for more information from the EMA on GVP.

Regardless of the source, any new or altered regulations, or information that concerns pharmacovigilance must be routinely evaluated. This involves conducting impact assessments on immediate procedures as well as broader pharmacovigilance strategies, followed by effective communication of these findings to relevant stakeholders.

Regulatory Intelligence is of course at its most important as a patient safety activity. While drug developers and Marketing Authorization Holders (MAHs) may face commercial consequences, the primary concern should always revolve around potential impacts on public health.

The significance of routine acquisition, evaluation, and reporting of Regulatory Intelligence information is therefore critical.

How Aegisana’s Regulatory Intelligence service can support you?

An expert local network.

The Aegisana Pharmacovigilance team, together with our network of partners, continually monitor for Regulatory and other changes. We have the experience and expertise required to quickly assess and understand the scope, potential safety implications, and risks to clients and patients.

We provide a comprehensive well- documented analysis of changes and/or new information, allowing you to consider and respond accordingly, minimizing risk, and remaining compliant ahead of the curve.

Accurate & reliable information.

Our aim is to build trust and confidence, and reliable and accurate Regulatory Intelligence is one way in which we ensure your peace of mind with compliance and safety.

Ultimately, we want you to be sure that together we’re focused on protecting the health of your patients, the safety of your products, and that you’ve made the right choice of pharmacovigilance services partner.