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Session 7: Track 4: Teamwork: Other Best Practices for Successful Partnerships
Session Chair(s)
Peter Terbeek, MBA
Senior Director, Regulatory Operations
United States
Successful submissions require a clear strategy, good communication, delineated roles and responsibilities, and trust in the people and processes. Technical validation is crucial but making the dossier as easy as possible to review is equally important. The presentations in this session will cover the importance of identifying the right team members for various types of submissions/submission strategies and understanding the value and skill sets they bring to the project.
Learning Objective : At the conclusion of this session, participants should be able to:
Speaker(s)
Capturing the Value of Multi-Stakeholder Teams to Support Product Submissions in Emerging Markets
Brooke Leslie Czapkowski, MBA
Pfizer, United States
Global Submissions Manager
Achieving a New Drug Application Approval, Who is on Your Submission Team?
LaTarsha Jones, MSc
Indivior Inc., United States
Senior Manager, Global Regulatory Operations
Avoiding Rejections: How Validation and Best Practices Can Lead to Successful Submissions
Sandra Krogulski, MA
Bristol-Myers Squibb Company, United States
Director, GRSO Innovation and Business Operations Lead
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