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Session 7: Track 4: Teamwork: Other Best Practices for Successful Partnerships
Session Chair(s)
Peter Terbeek, MBA
Executive Director, Regulatory Data and Document Operations, Astellas Pharmaceuticals, 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)
Brooke Leslie Czapkowski, MBA
Global Submissions Manager, Pfizer, United States
Capturing the Value of Multi-Stakeholder Teams to Support Product Submissions in Emerging Markets
LaTarsha Jones, MSc
Senior Manager, Global Regulatory Operations, Indivior Inc., United States
Achieving a New Drug Application Approval, Who is on Your Submission Team?
Sandra Krogulski, MA
Senior Director, Regulatory Digital Strategy and External Engagement, Bristol Myers Squibb, United States
Avoiding Rejections: How Validation and Best Practices Can Lead to Successful Submissions
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