Literature Surveillance for Pharmacovigilance: Tracking Emerging Risks

What is Literature Surveillance?

Literature surveillance involves the continuous monitoring of scientific publications, clinical studies, and medical journals to identify new safety concerns related to approved drugs or medical devices. Regulatory authorities such as the FDA and EMA require regular literature reviews to track the emergence of adverse events, drug interactions, or previously unreported risks.

At Viltis, we offer comprehensive literature surveillance services to help pharmaceutical and biotech companies stay ahead of potential safety risks. By regularly reviewing global scientific literature, we ensure that new information regarding drug safety is captured and reported to regulatory bodies.

Why Literature Surveillance is Crucial for Drug Safety

1. Identifying New Risks: Scientific literature provides a wealth of information that might not surface through spontaneous adverse event reports alone. Through literature surveillance, Viltis helps identify new risks or side effects that emerge from published case studies, clinical trials, or observational research.

2. Tracking Long-Term Safety Data: Literature often contains data on long-term drug safety and rare adverse events that may only become evident after a drug has been in use for several years. Regular literature reviews help ensure that this data is not overlooked, contributing to the drug's long-term safety profile.

3. Global Reach: Literature surveillance is a global activity, encompassing publications from various countries and regions. Viltis’ surveillance team has the expertise to scan publications from major international sources, ensuring that no safety signal goes unnoticed, no matter where it is reported.

4. Regulatory Submissions: Once new risks are identified through literature surveillance, Viltis prepares and submits the necessary safety reports to the relevant regulatory authorities. This may include updating the product’s safety profile, labeling changes, or even issuing safety alerts if necessary.

How Viltis Conducts Literature Surveillance

• Automated Literature Monitoring: We leverage cutting-edge technology to automate the scanning of global scientific literature. This allows us to quickly identify new safety concerns and provide timely reports to our clients.

• Expert Review: Our team of pharmacovigilance experts carefully reviews the identified literature to assess its relevance to the safety of your product. If a safety signal is detected, we work with you to determine the appropriate regulatory response.

• Continuous Monitoring: Literature surveillance is not a one-time activity. Viltis provides ongoing monitoring services to ensure that your product remains safe and compliant with all global regulations throughout its lifecycle.

Stay Ahead of Emerging Risks with Literature Surveillance
By actively monitoring the scientific literature, Viltis helps companies stay ahead of emerging safety risks, protecting both patients and the company’s reputation. Our literature surveillance services ensure that you are always informed of new developments in drug safety, allowing you to take action before any issues escalate.