Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Thomas Chatzopoulos, Vice President, QPPV Office
What do you do at ProPharma? How does your role support improving the health and safety of patients?
I am Vice President of the QPPV Office. Together with my teams we are providing Qualified Person responsible for Pharmacovigilance (QPPV), local QPPV (LPPV), Pharmacoviliance System Master File (PSMF) and Safety Data Exchange Agreement (SDEA) services for our clients. Our team ensures that the clients have a nominated contact PV person for Competent Authorities and that their PV system is running smoothly, collecting all relevant safety information to finally ensure that the products on the market have a favourable benefit/risk ratio.
What do you like best about working with clients?
To help our clients bring products to the market or extend their global reach. Also, the diversity of needs ofour clients is exciting. The first point in time from a product life cycle perspective, when the QPPV Office can help our clients is during late stage clinical trials. During this phase we can strategically consult with the client to plan for their marketing authorisation application and set direction. From there onwards we are setting up the entire PV system from a process, technology and interface perspective.
The most exciting work for the QPPV Office team is to support clients with products in a late stage clinical trial with setting up their PV system in line with the local and global PV requirements. Also, for established products or markets, we may get exciting challenges where our expert knowledge is required, e.g. to implement risk minimisation activities or post-authorisation studies. Finally, we work together with the client to ensure the health and safety of patients.
Describe the biggest challenge facing our clients/industry today. How are we addressing this?
Clients are trying to keep up with the fast pace of changes in the PV legislation and many individual country requirements that go hand-in-hand with the expectation of commercial efficiencies. ProPharma supports this with our well-functioning regulatory intelligence process, aligned with the extensive world-wide QPPV/LPPV network, always striving for harmonisation as applicable and looking for efficiencies using synergies or new technologies.
What is a current trend you’re seeing in the industry and how does it impact our clients and patients?
Artificial Intelligence (AI) is the current trend in industry and beyond. Like a potent medicinal product, AI can do a lot of good things, but it needs to be carefully used and to not cause harm. The good thing is that it facilitates and speeds up our work. It helps us to speed up our analysis of big data in the health care sector, and to perform a thorough analysis, ensuring development of new drugs which helps our clients and patients.
On the other side, it is scary how AI can manipulate data. Theoretical discussions that superintelligent AI cannot be contained and may decide the fate of humanity in the future leads to the open question: Can we establish control mechanisms for the AI to prevent harm and ensure the positive effects prevail?
What value does a client gain by working with ProPharma’s QPPV office experts?
Our clients gain a trusted partnership to develop customized strategies together with the client aligned to global and local regulations. Our dedicated team of experts embedded into a network of knowledgeable PV colleagues all over the world, ensure that our clients and our QPPVs always have the right experts available and required resources they need.
