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…
Building strong relationships with patients so that you can get first hand information and learn about adverse effects as soon as possible is crucial for pharmacovigilance professionals.
Better understanding of patients and their opinion on medicinal product balance between efficacy and potential adverse reactions. What level of side effects is acceptable to keep the treatment compliance high enough.
Building trust and openness in communication, clear and transparent collaboration, transparency in decisions and respect for patients’ feelings, senses and needs.
Getting information from “first hands”, building a strong relationship with patients. Educating for better understanding of medicine, its mechanism of actions, disease features and ways of control. Engaging patients into a dynamic collaboration with physicians, pharmacists, patient advocate groups. Empowering and encouraging patients for direct communications and reporting adverse effects directly to Pharma or via healthcare professionals.
Pavel Garkaviy is the Medical Director at Early Clinical Development CVRM. Pavel joined AstraZeneca Sweden in 2015, and held various positions within patient safety and clinical development. Pavel is the Medical & Scientific Lead for early phase studies excellence partnerships with CROs, and a member of Cardio-Vascular Safety Knowledge Group. Since 2005, he has been working for several CRO/Pharma and gained extensive hands-on experience, in early and late stage of R&D, leading teams and projects, risk management, medical monitoring, pharmacovigilance, regulatory interactions. Pavel qualified as a medical practitioner in 2004, certified in cardiology and earned his PhD in 2009. Currently studying for an MBA (2020/2021) at Imperial College Business School. He worked as a physician in cardiology/ICU department, associate professor, co-investigator and lecturer at Medical University. In his free time Pavel likes training and running, reading, listening to music, hiking and fishing.