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Evolving Your Regulatory Information Management Strategy to Meet the Changing Business Environment
Session Chair(s)
Austin Nesseth
Manager, Advisory Services
Kinapse Inc., United States
Complexity is growing in the global regulatory environment with new regulations coming into play (regulated product submission (RPS), identification of medicinal products (IDMP), social media, etc.). Additionally, new highly virtual collaborative business models are emerging and will be common in the near future. In this session, a summary of key trends that impact a regulatory information management (RIM) strategic plan will be discussed. The speakers will detail how other companies are approaching these changes and evolving their RIM strategies and investment plans.
Learning Objective : Discuss the key strategic components of a regulatory information management (RIM) plan; Identify ideas presented to consider drafting a plan for their own company.
Speaker(s)
Adapting Business Process to Support Global RIMS
Michelle L. Charles, MPH
University of Pennsylvania, Perelman School of Medicine, United States
Director, Regulatory Affairs, Gene Therapy Program
Lean Six Sigma For Delivering High-Velocity RIMS Strategies
Christopher P Hanna, PhD, PMP
Kattner-Thalmann Partners, United States
Principal