The surge in the development of combined products, which integrate medicinal products, medical devices, and digital health technologies, presents significant challenges for pharmaceutical companies. The lack of a harmonised regulatory framework across different jurisdictions complicates the efforts, while the awareness of medical device requirements often falls short among development teams. These complexities necessitate innovative collaboration models and adapted ways of working. This session will explore the multifaceted challenges of developing combined products and propose strategies to effectively bridge the gap between pharmaceuticals and medical devices. Medical writers are crucial to this process, offering a unique skill set essential for facilitating this integration. This session will discuss the evolving role of medical writers and the new competencies they need to embrace to contribute effectively to the development of such products.
Navigating the Challenges of Combined Product Development: The Essential Role of Medical Writers
Kathy Wang, AstraZeneca AB, Sweden
Kathy Wang is a seasoned regulatory affairs professional with a robust track record in the medical device and drug-device combination product sectors. As the Regulatory Affairs Director for Devices and Digital Therapeutics at AstraZeneca, she plays a pivotal role in supporting the development and marketing of combined drug-device products. Kathy offers strategic regulatory guidance throughout the product lifecycle, from pre-clinical phases to market launch. Her international experience, gained from living and working in China, Australia, and Sweden, has fuelled her strong interest and expertise in global regulatory affairs.