Phoenix Arizona, USA
ArisGlobal Booth: 515
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How can Regulatory Affairs Meet the Needs of Investigational Products, Scale for Future Needs, and Operate Cross-functionally?
Date & Location:
Monday, 12 September at 11:15 – 11:35AM MST | Ignite! Stage (booth 337)
Join us, as Laura Jones, Director of Product Management Regulatory Information Management Systems, ArisGlobal, discusses 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.
In this session, we will answer the following:
• 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?
Laura has 24 years of Information Systems third tier experience supporting a wide array of technologies concurrent with 23 years Pharmaceutical and Biotechnology Regulatory industry experience. Proficient in R&D technologies related to submissions and content management. Extensive knowledge of global agency guidance/regulations with a specialty in electronic submissions and submission management. Managed various System design and implementation projects for R&D systems as well as content management systems integration activities.