In this presentation, we will discuss the shifts that require Regulatory Affairs intervention in the investigational clinical study process, and how regulatory affairs can manage this process and liaise cross-departmentally efficiently. Additionally, we will discuss how Regulatory can optimize the use of a scaled-down RIM system and how organizations can scale their regulatory systems for the future as they move towards marketing a product. We’ll dive into the regulation changes surrounding this shift and the impact they will have on current clinical trial processes and outline why a holistic approach to regulatory affairs can streamline and strengthen investigational product submissions.
Learning Objectives:
How can Regulatory Affairs manage investigational clinical trial registration efficiently?
What regulations are causing the shift from clinical operations to regulatory affairs for investigational clinical study registrations?
How can organizations prepare for and maximize the transition from investigational products to marketed products?