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Not all countries have the same PV requirements, and their regulations are constantly changing, so keeping fully up to date is a an essential and critical part of maintaining compliance.
The health and safety of a single patient in 1848 was the initial driving force behind the introduction of pharmacovigilance, (PV) and as the need for it has been recognised it has evolved, with regulating authorities in countries around the world developing their own guidelines, regulations, and laws to protect patient safety.
Today, the PV regulatory intelligence landscape has become extremely complex. Whilst new countries create brand new legislation, and existing countries change and update their existing legislation, international bodies strive for harmonization to make pharmacovigilance more transparent and simplified in a global marketplace.
Despite these harmonization efforts, the priorities and speed of implementation of universal PV guidelines in different countries creates many differences and specific local requirements. And this is the foundation of and need for Local Regulatory Intelligence, because to protect patient safety, and be compliant in different markets, companies need to consider these local differences and their regular changes alongside regulations and requirements at the harmonised global level.
We typically monitor regulatory updates and changes on a weekly basis, utilising both publicly available data from National Competent Authorities and international sources, as well as information from our broad network of local PV experts.
This initial collection of information is then triaged to focus on what is relevant for pharmacovigilance.
The PV relevant regulatory updates, changes, and other developments are then further analysed to provide a clear understanding of the timing and potential implications for products and business strategies.
We share any Regulatory Intelligence that is specifically relevant to a client within 3 working days, and in addition, we also typically share all our monitoring results with clients on a weekly basis.
We also capture all relevant news, updates, or changes in our knowledge management platform iViReg.
In addition to routine monitoring, we also provide strategic guidance on navigating and mitigating any potential regulatory non-compliance or other business and safety impacts.
iVigee is a pioneer in the field of Local Regulatory Intelligence, and we have developed our iViReg platform directly for the needs of efficient pharmacovigilance. It takes publicly available information and enriches that with regular inputs from our network of Local PV experts in 120+ countries across the world. It also takes additional validated contributions from our global community of subscribers.
This enables our internal team of experts to analyse and interpret the potential pharmacovigilance and regulatory impacts from changes in local legislation, backed up with customised intelligence reports, to give you real, actionable insights that are tailored to your specific needs and challenges.
We understand the growing complexity of the global pharmacovigilance regulatory landscape, marked by the continuous introduction of new legislation or modification of existing rules, and the emergence of harmonisation efforts across regions. Despite these unifying initiatives, local national authority requirements remain diverse and intricate.
Our expertise lies in successfully navigating our clients through this complexity to ensure their compliance and patient safety, and our proactive approach to monitoring and guidance not only maintains that, but it also empowers your strategic decision-making.
