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Session 9 Track 4: Dynamic Submission Planning - Plan, Replan, and Execute
Session Chair(s)
Rob Labriola, MS
Exec. Director, Regulatory Operations
Garuda Therapeutics, United States
Don’t let traditional practices and legacy processes hold you back. The regulatory submission process is complex, time-consuming and involves many participants. If your submission contains mistakes or inaccurate information, your product’s future may be in jeopardy. The key to success is superb submission planning. During this session we will review the basics of effective and timely submissions, the need for team collaboration, and the use of technology. The planning process begins with regulatory strategy, identifying key components and deliverables required, including health authority interactions, develop a project plan with sufficient detail to provide guidance to the submission team, while reaching the goal. In this session we will provide best practice ideas for the techniques, tools and how to bring it all together in a plan that gets it right the first time.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize the value of effective planning
- Identify ways to effectively manage resources and timelines
- Describe and understand how team collaboration and an effective team strategy achieve submission goals
Speaker(s)
The Art of Submission Planning: From Strategy to Filing
Cassandra San Jose, MS, PMP, RAC
Biogen, United States
Director, Submission Planning and Resource Management
Tools for Successful Regulatory Submission Planning and Management
Stephanie Hughes
Syneos Health, United States
Manager, Global Regulatory Affairs Solutions
BLA/MAA Case Study and Lessons Learned
Adair Turner, MSc, RAC
Cencora Pharmalex, United States
Sr. Director, Head of Regulatory Affairs US