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Session 3 Track 4: Be Prepared! Submission Management for Health Authority Filings
Session Chair(s)
Kevin Tompkins, MBA
Executive Director, Regulatory Information & Submission Management
Bristol Myers Squibb, United States
“By failing to prepare, you are preparing to fail.”
Regulatory submissions are complicated. While trying to compile a high quality submission package to meet health authority requirements, you are working with multiple stakeholders and aggressive timelines within your organization. It can become overwhelming as the days pass and deadlines missed with the submission date fast approaching. Effective submission project management can help you mitigate those challenges and have a plan to meet your target submission date. This session will give suggestions and strategies to keep the project on track in order to deliver a high quality submission to health authorities.
Learning Objective : At the conclusion of this session, participants should be able to:
- Compare and identify strategies for increasing the efficiency of your cross-functional submission teams
- Apply best practices and tools to project manage Health Authority submissions
- Best practices for partnerships to manage resources and timelines
Speaker(s)
Teamwork for Timelines; Our Regulatory Project Management and Publishing
Dom Moloney, PMP
PRA Health Sciences, United Kingdom
Associate Director, Regulatory Project & Submission Management
Submission Management: Who Needs Project Management?
Patricia Oliva Millonig
bluebird bio, United States
Senior Director, Regulatory Operations and Compliance
Supporting Cross-Functional Teams to Execute a Successful Global Filing
Sandra Krogulski, MA
Bristol-Myers Squibb Company, United States
Director, GRSO Innovation and Business Operations Lead
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