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Session 8 Track 2: Transforming Regulatory Information Management Through Innovation
Session Chair(s)
Venkatraman Balasubramanian, PhD, MBA
SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States
It is increasingly becoming clear that data is at the center of most decision-making, both in our personal lives and in enterprises. Within regulatory, over the past three decades, we have gone full circle from data to documents to knowledge and back to data. How can data-intensive regulatory business processes be supported by rich information management applications where expectations of ubiquity and better user experience are of utmost importance? What can enterprise implementations of systems learn from consumer applications such as Amazon? How can innovations such as structured authoring and artificial intelligence transform regulatory? What is the industry doing about taking an end-to-end view of regulatory information management (RIM)? This session will have a reputed panel of experts sharing their views on how the industry must innovate and transform to the next generation of capabilities.
Learning Objective : Upon completion of this session, the participant should be able to:
- Understand how regulatory is increasingly become data-centric at its core
- Review how state-of-the art technologies and capabilities could transform RIM
- Understand what the industry is doing to adopt a holistic approach to RIM
Speaker(s)
Information and Connection
Matt Neal, MA
Atara Biotherapuetics, United States
Senior Director, Regulatory Affairs Operations
Eliminating White Space in Managing Marketing Products
Peter Lassoff, PharmD, RPh
Syneos Health, United Kingdom
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell
DIA’s RIM Working Group: Its Mission, Vision, and Value to Industry
James Nichols
Phlexglobal - Now Cencora Pharmalex, United States
Chief Product Officer
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