Safety Communications.
Proposal, development and distribution to stakeholders.

What are Safety Communications?

Safety Communications regarding human and veterinary medicinal products to patients, healthcare professionals, and veterinary experts is a vital public health responsibility aligned with the objectives of Pharmacovigilance and Veterinary Pharmacovigilance.

It is an integral aspect of the safe and effective use of medicines, preventing harm from adverse reactions (ADRs) and contributing to the protection of patients, animals, and overall public health.

The term ‘Safety Communication’ has a broad scope as outlined in the EMAs Good Pharmacovigilance Prattices (GVP) Module XV.B.2 – ‘Safety communication should deliver relevant, clear, accurate and consistent messages and reach the right audiences at the right time for them to take appropriate action.’. This therefore includes information packaged with products such the Summary of Product Characteristics (SmPC), Package Information Leaflet (PIL) and Package Labelling.

However, Safety Communications are generally more serious in nature and are issued for important new safety information on authorised medicines by Marketing Authorisation Holders (MAHs) and Health Authorities (HAs).

Safety Communications tend to relate therefore to major safety issues: market withdrawal or suspension of a medicine, new contraindications or warnings, restriction of use, product defects, etc.

Safety Communications are therefore aimed at informing stakeholders about new information on known risks, or previously unknown risks, from a product’s use.

It is directly connected to Signal Management because it is often recommended as an action following thorough signal assessment and potential changes in the Benefit-Risk Profile of a product and its conditions of use.

How Aegisana’s Safety Communication service can support you?

Process in practice.

Aegisana’s Pharmacovigilance team has extensive experience with the proposal, development and distribution of Safety Communications to all relevant stakeholders.

As Signal Management experts, we understand the entire process and know exactly what communications may be required, when, and by which routes, to ensure patient safety and your compliance.

Consistent & clear.

Your confidence in our pharmacovigilance services and solutions comes through excellent communications, and the consistent delivery of high-level support and outputs throughout your journey with us.

No matter how complex your requirements are, we can provide efficient and effective pharmacovigilance solutions to meet them.