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Regulatory Submissions, Information, and Document Management Forum

Session 9 Track 4: Regulatory Sourcing: Regulatory Sourcing - Who is Doing What and Some Real-World Industry Experiences

    Session Chair(s)
      Daniel F. Orfe, MS

      Daniel F. Orfe, MS

      • President & CEO
      • Regulatory eSubmissions, LLC, United States
    Regulatory submission outsourcing has been a major component in submission publishing for the past decade. Changes in technology and real-world industry experiences have contributed to a reexamination of outsourcing. This session will provide benchmarking and trending information regarding the use of outsourcing looking back over the past 10 years of industry tracking. An exploration will be provided on outsourcing practices over time, activities being brought back in house, and which regions are becoming more active in leveraging outsourcing. Two industry organizations will provide insights into their own experiences with outsourcing touching on the pros, cons, beneficial strategies, and pitfalls to avoid.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe current outsourcing trends and the fundamental reasons for that trending
    • Outline how companies have benefited from outsourcing
    • Apply the information provided by the panel to outsourcing decisions within their own organizations
      Steve  Gens, MS

      Regulatory Sourcing - Who is Doing What?

      Steve Gens, MS

      • Managing Partner
      • Gens and Associates Inc., United States
      Heather  Sinsel

      Sourcing Experiences and Insights – Pros, Cons, Beneficial Strategies, and Pitfalls

      Heather Sinsel

      • Manager, Regulatory Operations and Submissions
      • Inovio Pharmaceuticals, Inc., United States
      Kevin  Tompkins, MBA

      We Have How Many Submissions?!? Sourcing at a High-Volume Organization

      Kevin Tompkins, MBA

      • Director, Head of North America, Global Submissions Management
      • Teva Pharmaceuticals, Inc, United States