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Bethesda North Marriott Hotel and Conference Center

2018 年 02 月 05 日 7:00 上午 - 2018 年 02 月 07 日 3:00 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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

Session Chair(s)

Daniel Orfe, MS

Daniel Orfe, MS

President and 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

Speaker(s)

Steve Gens, MS

Regulatory Sourcing - Who is Doing What?

Steve Gens, MS

Gens & Associates Inc., United States

Managing Partner

Heather Sinsel

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

Heather Sinsel

Inovio Pharmaceuticals, Inc., United States

Manager, Regulatory Operations and Submissions

Kevin Tompkins, MBA

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

Kevin Tompkins, MBA

Bristol Myers Squibb, United States

Executive Director, Regulatory Information & Submission Management