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Session 6A: Business Track - Actions to Streamline Data and Facilitate Global Submissions
Session Chair(s)
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs
Independent, United States
Regulatory teams across companies are facing extraordinary market conditions, constantly shifting regulations with multijurisdictional requirements, and increased pressure to register their products with reduced budgets and significant resource constraints. Keeping abreast of changes in the endless surge of pending legislation, not to mention newly enacted and existing regulations that affect your regulatory approvals, can be a daunting task. This session will review solutions to identify, monitor and track all potential regulatory changes, to anticipate risk opportunities and prepare for them with internal controls.
Speaker(s)
Actions to Streamline Regulatory Data
Ravi Varahalu
MakroCare, United States
Associate Director, Strategic Consulting
Leveraging Regulatory Information In a Complex Global Environment
Thomas Noto
Lexicon Pharmaceuticals, United States
Senior Director, Regulatory Operations
Actions to Streamline Data and Facilitate Global Submissions: Document Preparation and Management
Tina Nyman
Sunovion Pharmaceuticals Inc., United States
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