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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 7: Track 4: Teamwork: Other Best Practices for Successful Partnerships

Session Chair(s)

Peter  Terbeek, MBA

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:
  • Recognize the strategic and operational contributions of submission team members
  • Identify and explain certain best practices that contribute to successful submissions
  • Identify challenges specific to submitting in emerging markets
  • Speaker(s)

    Brooke Leslie Czapkowski, MBA

    Capturing the Value of Multi-Stakeholder Teams to Support Product Submissions in Emerging Markets

    Brooke Leslie Czapkowski, MBA

    Pfizer, United States

    Global Submissions Manager

    LaTarsha  Jones, MSc

    Achieving a New Drug Application Approval, Who is on Your Submission Team?

    LaTarsha Jones, MSc

    Indivior Inc., United States

    Senior Manager, Global Regulatory Operations

    Sandra  Krogulski, MA

    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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