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What is Pharmacovigilance and what you need to know?

Whilst medicines and vaccines have provided remarkable benefits for treating health problems and disease prevention, they can also have unexpected side effects. These unintended consequences, often undesirable, underscore the critical importance of pharmacovigilance.

Pharmacovigilance encompasses the science and activities dedicated to the identification, evaluation, comprehension, and mitigation of adverse effects and other medication/vaccine-related issues.

While all medicines and vaccines undergo exhaustive safety and efficacy assessments during clinical trials before gaining approval for use, these trials typically involve a limited number of carefully chosen participants and a relatively short timeframe.

Consequently, certain side effects may only surface once these products are marketed and used among diverse populations, including individuals with various existing health conditions, who may already be using other products, over extended periods.

The pharmaceutical industry, like healthcare in general, shares a common commitment to ensuring patient safety, striving to minimize harm, and optimizing the therapeutic benefits of medications through vigilant pharmacovigilance practices.

Click for information on pharmacovigilance from the European Medicines Agency (EMA).

Click for information on Clinical SafetyVeterinary Pharmacovigilance, and Cosmetovigilance.

The aims of pharmacovigilance within the industry closely align with the broader goals in healthcare. These shared objectives focus on safeguarding patient well-being by accomplishing the following key aims:

Identifying Unacknowledged Drug Hazards.

The early detection of potential risks associated with pharmaceutical products that may not have been previously recognized. This involves a comprehensive assessment by pharmacovigilance professionals to uncover potential dangers linked to medications.

Clarifying Predisposing Factors.

To discover the factors that might make individuals more susceptible to adverse drug reactions or complications. Understanding these predisposing factors helps healthcare professionals make informed decisions about patient care.

Discrediting False Safety Signals.

Eliminate any misleading or inaccurate safety signals associated with medicinal products. This requires rigorous investigation by pharmacovigilance experts to distinguish genuine concerns from unwarranted fears.

Quantifying Risk in Relation to Benefit.

Quantitatively assess the balance between the risks and benefits of drug therapies to determine the overall safety and efficacy of pharmaceutical products.

Pharmacovigilance services.

Why choose Aegisana for your pharmacovigilance requirements?

Aegisana is dedicated to understanding your unique requirements. No matter where you are in your product/portfolio journey, our expertise, clear, and transparent systems approach ensures your confidence in our ability to provide control and oversight for your Pharmacovigilance (PV) systems and patient safety.

A flexible Quality Management System (QMS).

Backed by our robust Quality Management System (QMS) and our seasoned pharmacovigilance team, we offer flexibility in adapting our system to seamlessly align with your project’s specific demands.

This adaptability ensures full compliance while effectively minimizing and managing risks to both patients and your products.

Communication, reliability, & trust.

At the core of our service philosophy lies a belief in the fundamental elements of a successful and enduring strategic partnership.

We understand that good communication, unwavering reliability, and trust, are the cornerstones of building strong relationships throughout the entire product life cycle and beyond individual projects.