Navigating the regulatory landscape of the Italian pharmaceutical market can feel like driving through the winding streets of Rome—exciting, but high-stakes and requiring expert local knowledge. In Italy pharmacovigilance services (PV) isn’t just a box to check; it’s a rigorous, patient-centric system governed by the Agenzia Italiana del Farmaco (AIFA).

For pharmaceutical companies looking to maintain compliance while ensuring patient safety, DDRegpharma provides the bridge between global standards and local Italian requirements.

The Italian Context: Beyond Standard GVP

Italy operates under the National Pharmacovigilance Network (RNF), a sophisticated system that collects, manages, and analyzes suspected adverse drug reactions (ADRs). While EU Good Pharmacovigilance Practices (GVP) provide the foundation, AIFA has specific nuances that require a “boots on the ground” approach:

• The Local Contact Person (LPPV): According to national legislation, AIFA may require the appointment of a local pharmacovigilance contact person who must be registered in the RNF and speak the national language.

• Rapid Reporting Timelines: The transition to the new RNF (activated in 2022 and further refined into 2026) has streamlined electronic reporting but heightened the expectation for accuracy and speed.

• Regional Integration: Italy’s PV system is uniquely integrated with regional centers, meaning safety signals often emerge from a localized level before reaching the national stage.

Why DDRegpharma is Your Partner in Italy

DDRegpharma doesn’t just offer services; we offer peace of mind. Our approach combines deep medico-regulatory expertise with AI-driven technology to ensure your PV system is both robust and adaptive.

Our Core Italian PV Services:

• Local Person for Pharmacovigilance (LPPV): We provide a dedicated, Italian-speaking expert to act as your primary liaison with AIFA, ensuring your company is always represented accurately in the RNF.

• End-to-End ICSR Management Services: From receipt to final submission, we handle Individual Case Safety Reports using ICH E2B(R3) compliant databases, ensuring every ADR is triaged and reported within the mandatory 7 or 15-day windows.

• Global and Local Literature Monitoring: Our team conducts systematic weekly reviews of both international databases (PubMed, Embase) and local Italian scientific literature to catch safety signals that others might miss.

• Risk Management & Signal Detection: We draft and maintain Risk Management Plans (RMP) and conduct proactive signal detection to anticipate safety trends before they become compliance hurdles.

• Aggregate Safety Reporting: Our experts author high-quality PSURs, DSURs, and PBRERs, ensuring that the benefit-risk profile of your product is always clearly communicated to the authorities.

The Technology Advantage: VITALIC & RegIntel

At DDRegpharma, we believe technology is the key to minimizing human error. We utilize our proprietary AI-driven Regulatory Intelligence platform to stay ahead of changing AIFA guidelines. This allows our clients to pivot quickly when new safety measures—such as modified risk minimization materials—are mandated.

Compliance That Drives Growth

Safety shouldn’t be a bottleneck. By ensuring audit-ready PV systems, DDRegpharma helps life sciences companies accelerate their revenue growth. We take care of the complexities of the Italian “Decree 30 April 2015” and subsequent updates so you can focus on what matters most: bringing life-saving therapies to patients.

“In the world of drug safety, ‘almost compliant’ is not an option. DDRegpharma ensures that your Italian PV operations are as precise as they are proactive.”