Expert Interpretation and Analysis of Regulatory Intelligence Are Key to FSP-Delivered Pharmacovigilance

PPD FSP experts deliver a range of capabilities to our clients, including the following examples of how our timely identification, interpretation and expert analysis of PV RI enabled one China-based client to perform compliant and cost-effective pharmacovigilance as they navigated growth amid complex global markets.

Expedited reporting: At the outset of this new client partnership, our PPD FSP Pharmacovigilance solutions team reviewed the regulatory reporting rules in the client’s existing safety database and reconciled to ensure those rules aligned with the latest regulatory intelligence in each country. This process revealed discrepancies in the reporting of comparator products, leading us to research all relevant country-specific regulations to eliminate incorrect or irrelevant information and generate a single source of accurate regulatory data. We also advised the client on when to submit comparator-related reports to those agencies without clearly specified guidelines and assisted in the setup of web portals to facilitate client reporting via the U.S. Food and Drug Administration’s WebTrader, European Medical Agency’s EudraVigilance and several relevant ethics committees.

China: In 2020, China overhauled its PV requirements. To institutionalize the systems and processes related to these new reporting requirements, our PPD FSP Pharmacovigilance solutions team first had to undertake extensive research into the adoption of International Conference on Harmonisation (ICH) guidelines in China. This research ultimately influenced the creation of a new submission process for the client. To best meet the needs of the potentially hundreds of China ethics committees (ECs) and Good Clinical Practice offices, we suggested the client use an electronic delivery platform to distribute reports to these institutions, which enabled a widespread distribution of safety reports quickly and efficiently. In three years of tracking safety reporting compliance with this client, their annual China EC Compliance rates averaged over 99%.

Brexit: While China was undertaking its regulatory overhaul, Brexit was also causing an additional set of changes in the United Kingdom. Most significantly, the Medicines and Healthcare products Regulatory Agency (MHRA) began to require that individual case safety reporting be performed either via their own gateway or a new Individual Case Safety Report (ICSR) submissions portal — with fewer than four months to set up and register accounts. Prior to official announcement of these changes, our PPD FSP Pharmacovigilance solutions team had already started preparing — including designating MHRA subject-matter experts and working with the client to ensure alternate submissions methods were in place if the Brexit political negotiations failed. Throughout the process, our team kept the client well-informed of all changes and created a system to track this topic and ensure it was reviewed at regularly scheduled client meetings. In the end, our group worked with the client and their safety database vendor to create an MHRA gateway that went live within days of Brexit going into effect, resulting in a seamless transition with no impact to safety reporting compliance.

Metrics: In navigating these and other challenges, this client relied on PPD FSP Pharmacovigilance solutions experts to steer the best course forward. The client initially had eight Investigational Medicinal Products (IMPs) and around 60 active protocols. In just four years, they expanded to 33 IMPs and approximately 130 protocols across more than 20 countries. In 2023 alone there were 49 identified updates in country-specific requirements; of these, roughly one-third were communicated to the client for their action and two-thirds were actioned internally within our PV team. Throughout this tremendous growth, our FSP PV team provided regulatory intelligence updates and proactive guidance on the requirements of new countries onboarding for clinical trials and post-approval expansion. This advanced analysis of regulatory requirements ensured that the safety database was configured and ready to produce the safety reports required; leveraged our network of in-country PV support to ensure readiness for local safety report submissions at time of approval; and ensured that, where necessary, the required delegation letters had been submitted in advance of safety reporting onset. Over the past years, our teams also assessed 16 products to be non-IMPs despite having been previously reported to global investigators, resulting in a reduction in overreporting and delivering cost savings to the client. Finally, we minimized cross-reporting of 35 non-client IMPs, which had been reported to all studies (including partner-sponsored and investigator-sponsored trials) and are now reported only to client-sponsored trials, resulting in further cost savings.