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Session 6B: Tools and Technology Track - Outsourcing Regulatory Activities
Session Chair(s)
Dominique Lagrave, PHARMD
Chief Regulatory Officer
Accumulus Technologies, United States
Many companies are going through internal efficiency exercises to reduce cost and remain lean; all the while, increasing capacity to ensure volume targets can be met. This session will outline operational efficiency initiatives – outsourcing select regulatory operations activities (publishing and management of regulatory information). It will detail planning activities, vendor selection, onboarding, and training.
Speaker(s)
Dominique Lagrave, PHARMD
Accumulus Technologies, United States
Chief Regulatory Officer
Is Regulatory Outsourcing Right for You?
Tony Catka, PHD
Ionis Pharmaceuticals, Inc, United States
Director Regulatory Policy and Intelligence
Submission Outsourcing - Stop working for it, make it work for you
Kim S. Smith, MBA
Bristol Myeres Squidb, United States
Buisness Opperations
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