How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
Enhance the communication between PV professionals to become more aware of patients’ needs
How to raise patient awareness regarding the importance of reporting ADRs?
It is important to take into consideration various methods and media (from reporting cards to links to health authority homepages, from safety reporting apps to addressing your concerns to your pharmacist or treating physician), in order to reach the vast majority of the patients. Patients are more aware than ever, due to the COVID-19 pandemic, about the possibility of having an adverse drug reaction to a product, and therefore we need to provide them with easy-to-use tools and direct access to reporting systems. Pharmaceutical companies work in close cooperation together with the health authorities and local trade associations for this common goal.
How to use AI most effectively to directly interact with patients and better manage drug benefits and risks?
Bots have been used to “talk” to customers for many years already. It is important to start using them more widely to help patients when they need support with reporting an adverse event. Also using chatbots by the medical information departments of the pharmaceutical companies can assist patients with their questions and indicate the right direction for their concerns. Though it sounds easier than it actually is, it is also important to give patients the possibility to get the right information at the right time in the right format. Some patients would like to be provided with high-level information, whilst others would like to dive in deeper, understand more about their disease and the recommended drugs. We need to create digital building blocks and enable our patients to decide for themselves what is the right amount of information
What kinds of new skill set needs are emerging for pharmacovigilance?
PV professionals were always proud of their scientific streak, analytical assessment skills, diligence, and an eye for details. But they also had a reputation of being introverted, a bit prone to over-control and -analyse facts. The times of a PV team grouped in the farthest end of a corridor have come to an end. We need to enhance our communication and listening skills, anticipate changes, be proactive, learn to navigate the growing AI landscape, but also become more aware and sensitive about patients’ needs. In the meantime, we also need to be able to “sell” our product – which is patient safety, internally, as well as externally.
Yvonne NANCIU, Country Head Pharmacovigilance at Bayer is a Medical Doctor (Specialty: Clinical Genetics) with a wide clinical and laboratory expertise, holding a
Masters´ degree in Pharmaceutical Medicine, and being passionate about Pharmacovigilance and patient engagement.
Yvonne has over 15 years of PV experience (global and local positions), working for JnJ in Germany, AbbVie in Switzerland in the past, and now having the position of Pharmacovigilance Country Head and German QPPV (Stufenplanbeauftragte) at Bayer in Germany since February 2021. Additionally, she is a lecturer for Pharmacovigilance at various German Universities (under-and post-graduate studies).