When discussing GVP pharmacovigilance, we are referring to a set of European guidelines that define how a pharmaceutical company must manage the safety of its medicines after they have received marketing authorisation. The acronym stands for Good Vigilance Practices, and these guidelines represent the primary reference framework for anyone working in pharmacovigilance, from in-house personnel to Contract Research Organizations (CROs) that manage pharmacovigilance activities on behalf of pharmaceutical companies.<\/p>\n\n\n\n
Understanding how the GVPs are structured, who is responsible for applying them, and which competencies they require is the first step towards building a pharmacovigilance system capable of successfully passing regulatory inspections without unexpected issues.<\/p>\n\n\n\n
Good Vigilance Practices (GVPs) were introduced as part of the European pharmacovigilance legislation adopted in 2010 and implemented in July 2012. Rather than being a single document, they consist of a collection of guidelines published by the European Medicines Agency (EMA) in collaboration with expert working groups from the EU Member States. They apply to Marketing Authorisation Holders (MAHs), the EMA itself, and national regulatory authorities, covering both centrally authorised medicines and those authorised at the national level.<\/p>\n\n\n\n
The objective of the GVPs is simple to state but challenging to achieve: to ensure that every safety signal associated with a medicinal product is identified, evaluated, and managed with the same level of diligence throughout the European Union. For this reason, GVPs in pharmacovigilance are not merely recommended best practices. They are a legal requirement, and failure to comply may result in significant findings during inspections conducted by national competent authorities or other regulatory bodies.<\/p>\n\n\n\n
The GVP guidelines are organised into modules, each covering a specific area of pharmacovigilance.<\/p>\n\n\n\n
The main modules include:<\/p>\n\n\n\n
Modules XI, XII, XIII, and XIV no longer exist as standalone chapters. The topics they were originally intended to cover have been incorporated into other EMA guidance documents. In addition to the core modules, the GVP framework also includes product- and population-specific considerations, covering areas such as vaccines, biological medicinal products, the paediatric population, and, more recently, pregnancy and breastfeeding. The guidelines are further supported by annexes containing definitions, templates, and abbreviations.<\/p>\n\n\n\n
The GVPs are continuously evolving, and the developments of the past year clearly demonstrate this. In July 2025, the European Commission adopted Implementing Regulation (EU) 2025\/1466, which amends Implementing Regulation (EU) No 520\/2012 and became fully applicable in February 2026. One of the most significant changes is that Marketing Authorisation Holders (MAHs) are no longer required to submit validated signals to the EMA through the standalone signal notification process. Instead, they must directly monitor EudraVigilance data and integrate it into their own signal management process, as outlined in Module IX, which is currently under revision.<\/p>\n\n\n\n
Module VII, which covers Periodic Safety Update Reports (PSURs), has already incorporated part of these changes. Periodic reports must now include an update on the effectiveness of risk minimisation measures. Anyone working in pharmacovigilance should therefore treat the GVPs as a living reference that requires continuous review, rather than as a manual to be consulted once and then filed away.<\/p>\n\n\n\n
Responsibility for the correct implementation of the GVPs does not rest with a single individual, although the central figure is the Qualified Person for Pharmacovigilance (QPPV). The QPPV is accountable to the regulatory authorities for the proper functioning of the company’s pharmacovigilance system and is responsible for ensuring that the Pharmacovigilance System Master File (PSMF) remains up to date and accurately reflects the company’s actual pharmacovigilance activities.<\/p>\n\n\n\n
Alongside the QPPV, several other roles are directly affected by the GVPs. These include professionals responsible for managing adverse reaction reports, preparing Periodic Safety Update Reports (PSURs), conducting internal audits, and communicating with healthcare professionals and patients whenever new safety concerns emerge. In smaller companies, these responsibilities may be handled by one or two individuals. In larger organisations, they are typically assigned to dedicated teams that must nevertheless share the same understanding of the regulatory framework.<\/p>\n\n\n\n
This is where training becomes essential. Simply memorising the GVP modules is not enough if, in day-to-day practice, employees do not know how to assess a safety signal or correctly prepare a PSMF. For professionals who want to gain a deeper understanding of operational pharmacovigilance processes, specialised pharmacovigilance training courses<\/a> provide a valuable starting point, whether they are already working in the field or approaching these roles for the first time.<\/p>\n\n\n\n Inspections conducted by AIFA or the EMA rarely identify critical findings simply because a written procedure is missing. More often, issues arise because the people responsible for applying the procedure do not fully understand why certain steps are required, or because staff turnover has brought new employees into the organisation without a structured knowledge transfer process. In this context, pharmaceutical training is not an optional expense. It is the difference between a pharmacovigilance system that works only on paper and one that performs effectively, even under regulatory scrutiny.<\/p>\n\n\n\n One aspect that is often underestimated is that GVP training is not limited to professionals working directly in pharmacovigilance. For example, Medical Information staff are often the first to receive reports of adverse reactions from patients or healthcare professionals. They must be able to recognise these reports and route them through the appropriate channels within the required timelines, which remain particularly strict for serious cases. If these employees have never received pharmacovigilance-specific pharmaceutical training, the risk of missing or delaying a report increases significantly, along with the likelihood of regulatory findings during an inspection.<\/p>\n\n\n\n Not all pharmaceutical training courses offer the same value. An effective GVP training programme should be designed around the actual roles and responsibilities within the company, rather than following a generic curriculum applied equally to everyone. Professionals responsible for PSURs, for example, require different knowledge and skills from those involved in audits or regulatory inspections.<\/p>\n\n\n\n When selecting a training programme, it is worth evaluating several key factors:<\/p>\n\n\n\n For companies that need to train multiple employees while ensuring consistency across different functions, a customised in-house training programme is often the most effective solution. It enables teams to work on real company cases instead of relying solely on generic theoretical examples.<\/p>\n\n\n\n Professionals working in pharmacovigilance know that GVPs continue to evolve, regulatory inspections are becoming increasingly rigorous, and staying up to date requires ongoing learning. LS Academy offers pharmacovigilance training courses designed both for professionals already working in the field and for those looking to enter it with the right skills. Courses are available in classroom settings as well as through customised in-house programmes tailored to the specific needs of pharmaceutical companies.<\/p>\n\n\n\n GVP<\/strong> stands for Good Vigilance Practices<\/strong>, the European guidelines that define how pharmaceutical companies, the European Medicines Agency (EMA)<\/strong>, and national competent authorities must manage pharmacovigilance after a medicinal product has received marketing authorisation. The guidelines are organised into modules numbered I to XVI<\/strong> and apply to all Marketing Authorisation Holders (MAHs)<\/strong> operating within the European Union.<\/p> <\/div> The main GVP guidelines are organised into Modules I to XVI<\/strong>. However, Modules XI, XII, XIII, and XIV<\/strong> no longer exist as standalone chapters, as their content has been incorporated into other EMA guidance documents. In addition to the core modules, the GVP framework also includes product- and population-specific considerations<\/strong>, covering areas such as vaccines and biological medicinal products.<\/p> <\/div> The primary responsibility lies with the Qualified Person for Pharmacovigilance (QPPV)<\/strong>, who is accountable to the regulatory authorities for the effective operation of the company’s pharmacovigilance system. Supporting the QPPV are several other functions, including adverse event management, internal audits, and regulatory reporting, all of which must apply the GVP requirements in practice, not just understand them in theory.<\/p> <\/div> No. Like most training providers in the pharmaceutical sector, LS Academy<\/strong> issues a certificate of attendance<\/strong> upon successful completion of the course. There is currently no officially recognised professional certification<\/strong> for individual pharmacovigilance professionals under the European regulatory framework.<\/p> <\/div> Yes, although not according to a fixed schedule. In July 2025<\/strong>, amendments to Implementing Regulation (EU) No 520\/2012<\/strong> were adopted and became fully applicable in February 2026<\/strong>. In addition, Module IX<\/strong>, which covers signal management, is currently under revision. Staying compliant therefore requires regular monitoring of new EMA<\/strong> publications and guidance updates.<\/p> <\/div> <\/div>\n\n\n\n When discussing GVP pharmacovigilance, we are referring to a set of European guidelines that define how a pharmaceutical company must manage the safety of its medicines after they have received marketing authorisation. The acronym stands for Good Vigilance Practices, and these guidelines represent the primary reference framework for anyone working in pharmacovigilance, from in-house personnel … Continued<\/a><\/p>\n","protected":false},"author":84,"featured_media":21462,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-21487","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/posts\/21487","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/users\/84"}],"replies":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/comments?post=21487"}],"version-history":[{"count":3,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/posts\/21487\/revisions"}],"predecessor-version":[{"id":21490,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/posts\/21487\/revisions\/21490"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media\/21462"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media?parent=21487"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/categories?post=21487"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/tags?post=21487"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Why Pharmaceutical Training Makes the Difference<\/strong><\/h2>\n\n\n\n
Pharmaceutical Training Courses for Companies: How to Choose the Right Programme<\/strong><\/h2>\n\n\n\n
What to Consider Before Choosing a Course<\/h3>\n\n\n\n
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In-House Training for Internal Teams<\/h3>\n\n\n\n
Frequently Asked Questions About GVPs in Pharmacovigilance<\/strong><\/h2>\n\n\n\n
<\/h3>\n","protected":false},"excerpt":{"rendered":"