Leading the session are seasoned professionals in the field, Arthur Kawasaki, M.Sc., MBA, and Kandarp Shah, Ph.D., RAC. Arthur brings over 29 years of experience across various sectors including pharmaceuticals and medical devices, having held senior roles at renowned companies like Eli Lilly and Exact Sciences. Kandarp offers a depth of knowledge in US regulatory approvals and international registrations, complemented by a strong research background in biological sciences. This session is particularly designed for regulatory affairs professionals, product development teams, quality assurance personnel, and other key decision-makers in the medical device, in vitro diagnostic, and pharmaceutical industries. Participants will gain a thorough understanding of differentiating between Regulatory Strategy and Regulatory Plan, identifying critical inputs, and developing a robust Regulatory Strategy. |