Meet the Expert
Filip Beljan: Heading up Insife’s unique service, the Global Regulatory Intelligence Club (GRIP)
GRIP, the Global Regulatory Intelligence Club for Pharmacovigilance, is a one-of-a-kind subscription service consisting of a comprehensive collection of global requirements, that have been collected and analysed by Insife’s pharmacovigilance experts. The team consistently assesses and interprets changes in legislation and finds the relevant new information for the GRIP members, taking that time consuming, but vital, job out of their hands.
Lead by Regulatory Intelligence Consultant Filip Beljan, the team helps pharma and biotech companies, big and small, as well as CROs, by taking on the work of tracking changes in global regulation. Filip sees them as detectives, picking out tiny details from large, unwieldy global documents, finding and interpreting the relevant information, then creating rules for the GRIP database.
So, how did Filip end up as a regulatory intelligence expert?
‘It took me quite a while to find my niche to be honest. I’d moved around and worked in as diverse fields as tourism, a construction office and a school for disabled kids. Then I got an administration job in PrimeVigilance and I’ve not looked back!’
Filip started his PV career in 2016 as a safety reporting assistant and he developed his role swiftly. As he learned more and more and developed his contacts at the regulatory agencies, the role naturally broadened. The company recognised his potential, and he was soon promoted and started working on the databases used for reporting ICSRs. By 2020, he was running the safety reporting team and working on updating and troubleshooting safety databases so that they meet regulatory requirements.
After a brief move to IQVIA in 2021, Filip was asked to return to PrimeVigilance as Regulatory Affairs Manager, a role he enjoyed until moving to Insife in June 2023, when he was looking for a new challenge.
The new challenge was Insife
GRIP is the brainchild of Insife CEO Martin Holm-Petersen and when Filip was approached by Insife to start the regulatory intelligence department, he was immediately excited by the idea and the challenge. As he develops the offering of GRIP, he is also developing his team and Filip is thoroughly enjoying building the department along with the service.
‘I’m so committed to what we’re offering the pharma industry, because we have a unique proposition not only because of the work my team are doing on a daily basis to keep with the regulatory changes globally, but because of the level of technology used. Insife’s technology really is staggering.’
Of course, having worked on the ground, using manual input and simple databases himself, he really knows what clients will benefit from.
‘I really wish I’d had the use of this service in my past roles, it would have saved so much time and manpower. We wouldn’t have to rely on using bloated, information heavy Regulatory requirements summaries to determine the reportability of each individual ICSR or SUSAR. With GRIP, you just get the relevant information to be able to know what to send, to whom and when. And if GRIP is combined with other Insife modules, like the submission module, an even greater level of streamlining and automatization is achieved by allowing users to auto-schedule the creation of submission entries.’
Accepting his expertise
Although Filip has only worked in PV for seven years, he is delighted to have found his niche in Regulatory Intelligence and safety reporting and to have become an expert in it. It’s not about knowing all the data and regulations, no human could possibly remember all of that for medicines, devices and vaccines for over 160 countries. From his perspective, it’s about applying the intelligence bit of Regulatory Intelligence. Not about learning the rules but interpreting them and that takes experience and confidence.
‘You need to have the confidence to sometimes disagree with rules that are being set. They are being set globally by humans and we’re all fallible, so sometimes we have to challenge things on behalf of our industry and our clients and that takes guts!’
Filip and his team will have to read hundreds of documents every year, which will often need translating too and only a handful of them might end up having really important data. So, checking of all the documents has to be done so nothing relevant is missed. That’s why he thinks of them as detectives, searching through all the evidence to find that one crucial piece that is important and pertinent to his clients.
‘The GRIP system and my team and I can help clients, CROs and agencies alike to communicate and share information and streamline their Regulatory Intelligence process. We think that many more companies could strongly benefit from what we are offering and we look forward to working with them.’
Learn more about GRIP