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On Demand 6 Track 4: Outsource Partners – Selection Process, Best Practices, and Case Study
Session Chair(s)
Daniel Orfe, MS
President and CEO
Regulatory eSubmissions, LLC, United States
This session will provide an exploration of outsource partner business practices. Best practices for the selection of an outsource partner that both meets the submission production needs as well as aligns with your organization culture will be examined. Methods for understanding and addressing the various unique considerations associated with particular outsource and insourced partners will be described. Lastly, the real-world submission production experiences of a service provider for a critical client submission will illustrate lessons learned, the sophistication of planning through experienced and dedicated project submission managers and best practices for submission production and partner interactions.
Learning Objective : At the conclusion of this session, participants should be able to:
- Ask impactful questions of potential outsourcing Partners during the selection process
- Recognize the different capabilities of your organizations various publishing Partners
- Identify best practices and recommendations for process improvement, operational effectiveness, and efficiency in an end-to-end submission process
Speaker(s)
How Do You Choose the Right One? Queries to Help Refine Your Choice in Outsourcing Partner
Jillian E. Carinci, MS
Biogen, United States
Senior Director, Head of Submission Sciences
Merck and its Outsourced Partners
Adam Bone
United States
Senior Specialist, Regulatory Affairs
Lessons Learned from Preparing and Submitting an IND Application for a COVID-19 Treatment Candidate
Efi Sergi, MS, PMP
PRA Health Sciences, United States
Associate Director, Regulatory Project & Submission Management