The Qualified Person for Pharmacovigilance (QPPV), mandatory in the EU and increasingly adopted in Africa, plays a critical role in drug safety. They manage a company's pharmacovigilance system, impacting quality, product safety, and regulatory compliance. THESYL offers tailored QPPV services and deep knowledge of Local Person for Pharmacovigilance (LPPV) requirements. Our expertise helps navigate the varying regulations of QPPVs and LPPVs across regions and offers access to local experts and the ability to provide scalable, customized solutions to meet your specific needs.
After a pharmaceutical product is approved and released to the market, monitoring its safety profile is critical. Our Post-marketing Pharmacovigilance services involve the continuous collection, assessment, and analysis of adverse event data from various sources, including healthcare professionals and patients. We ensure compliance with global regulatory requirements while safeguarding public health by identifying, assessing, and mitigating potential safety risks associated with the drug.
Effective Case Management is at the heart of pharmacovigilance. We specialize in managing adverse event cases by collecting detailed data, assessing the severity and causality of each case, and ensuring proper follow-up actions. This service includes the submission of Individual Case Safety Reports (ICSRs) to health authorities and sponsors, maintaining high standards of data integrity and regulatory compliance.
Our Signal Management services are designed to identify new safety concerns, or "signals," emerging from post-marketing surveillance. By systematically analyzing data from multiple sources, we detect potential risks early. Our experts prioritize these signals, evaluate their impact, and recommend risk mitigation strategies. This process ensures that any emerging safety issues are managed promptly to protect patients and meet regulatory expectations.
We prepare and submit comprehensive safety reports, such as Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs), to regulatory agencies worldwide. These reports consolidate safety data over a defined period, analyzing the benefit-risk profile of a product. Our team ensures that the reports meet international standards, helping sponsors maintain product safety and transparency throughout the product lifecycle.
A robust Risk Management Plan (RMP) is essential for ensuring the safe use of pharmaceutical products. Our services include the development, implementation, and ongoing evaluation of RMPs tailored to each product's safety profile. We work closely with clients to identify potential risks, propose risk minimization strategies, and monitor the effectiveness of these measures. Our RMPs are designed to comply with regulatory requirements and promote patient safety throughout the product’s market life.