The practice of pharmacovigilance (PV) has focused on the recording, evaluation and reporting of adverse drug reactions. The globalization of the pharmaceutical industry has led to efforts to harmonize PV practices around the world to enable a better understanding of the benefit-risk profile and risk communication of medicine. Even though PV has evolved over the past decade, there are still few areas of disunity in global PV practices. This article compares photovoltaic legislation in the United States, the United Kingdom, Canada and India in order to understand the areas of harmony of current legislation in all regions and to compare the requirements of health authorities with the recommendations of international organizations. Identifying potential areas of discord would pave the way for the development of solutions and strategies to create a complete photovoltaic system that can be easily implemented on a global scale, thus promoting safer use of drugs. Learn more about our pharmacovigilance audits, staff replenishment and recruitment services and contact us to begin the interview today. This blog provides a brief overview of some of the key requirements for setting up a photovoltaic system to support approved products in the United States. The FDA has developed a number of guidelines for the industry, but they are not legally binding documents and only highlight the FDA`s current thinking. Setting up a photovoltaic system can be a complex, time-consuming and expensive undertaking. More and more companies are choosing to outsource some or all of their PV activities to third-party PV service providers.

While this may allow for faster installation and lower costs, licensee retains ultimate responsibility for all PV activities and the safety of its products. If third parties or business partners are involved in the collection, processing or communication of security information, the licensee must ensure that there are security data exchange agreements (SDEAs) or PV agreements and contractual agreements. Regulatory requirements for expedited reporting of serious ICSRs are the same as in other ICH regions where reports must be submitted within 15 calendar days. In general, foreign declarations of drugs with the same active ingredient content as a product marketed in the United States must be declared serious and expected. Currently, there is no need to submit non-severe ICSRs to the FDA. A subtle but significant difference between expedited reporting requirements in the U.S. and other countries/regions is the validity of the IRB. In the EU, for example, it is necessary to have a patient identifier such as gender, age or age group, etc. (in addition to an identifiable registrant, a suspected product and a suspected RA). However, for reports in the United States, it is sufficient for a report to contain information indicating the existence of an individual patient.

The licensee shall ensure that adequate written procedures are in place to demonstrate that the following PV activities are being carried out: The licensee may request an exemption to replace PADER with the Periodic Benefit-Risk Assessment Report (RRRP) to align its internal periodic reporting obligations with those of other countries. This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiological evaluation of observational data on medicinal products, including biological medicinal products (excluding blood and blood components). In particular, this document provides guidance for (1) the identification of safety signs, (2) the pharmacoepidemiological evaluation and interpretation of safety signals, and (3) the development of pharmacovigilance plans. The World Health Organization (WHO) defines pharmacovigilance (PV) as “the science and activities related to the detection, evaluation, understanding and prevention of side effects or other possible drug-related problems.” [1] International efforts to address drug safety issues around the world were launched shortly after the Contergan disaster in 1961. Previously, PV and related activities included reactive techniques to address the risks associated with drugs once they had been marketed. In recent years, the scope and objectives of PV have expanded several times due to changes in the global pharmaceutical environment, improved access to medicines, different use of medicines, and the availability of newer and more powerful tools and databases for data tracking and analysis. However, the discipline must evolve to meet both the needs of the public health system and consumer expectations. ICH, CIOMS and WHO initiatives have made great strides in unifying global PV practices, but there is still no full level of harmonization of adverse event reporting systems and risk management strategies[3]. Definitions and reporting requirements continue to vary from one regulator to another, creating an environment in which manufacturers and healthcare professionals submit different data on the same product to different authorities.

In this case, public health and safety interventions may vary or be delayed. The key to successful PV in a modern world includes better global data sharing, more effective communication of drug safety and efficacy to all stakeholders, from manufacturers to healthcare professionals and patients, increased PV training in colleges and universities, and a more radical shift from reactive reporting on negative impacts to proactive sharing of Drug Safety Information. and risk management. The concept of pharmacovigilance – derived from the Greek and Latin “pharmacon” (medicinal substance) and vigilia (observer) – emerged seriously nearly 200 years ago among doctors and other health professionals. Initially, the practice consisted mainly of letters and reports from physicians on the safety and effectiveness of various drugs administered to their patients. Our safety and pharmacovigilance resources leverage in-depth knowledge of regulatory legislation and a focus on quality assurance to provide effective solutions for compliant global pharmacovigilance before and after approval. Learn more about our clinical operations recruitment and recruitment services. His expertise includes analyzing safety signals, writing case reports, mining data, and even conducting desk research. According to the FDA`s GMO guidelines, the correct identification and interpretation of “safety signals” is a very large part of good pharmacovigilance. Not only is high-quality pharmacovigilance now crucial for a successful pre-market pharmaceutical review, but also for post-market surveillance. .