Back to Agenda
Session 9 Track 1: Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships
Session Chair(s)
Rob Labriola, MS
Exec. Director, Regulatory Operations
Garuda Therapeutics, United States
This session will explore best practices that enable high-quality relationships between clients and vendors in the regulatory submissions space. We will delve into the ever-growing number of acquisitions and mergers/partnerships as it relates to strategy and execution in submissions operations. An examination into successfully shifting from a vendor-based RIM model to an in-house operation will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:- Define and explain operational performance with metrics and KPIs
- Analyze the scope and appraise the process for execution
- Identify tools, processes, and personnel necessary for success
- Employ different governance processes to create and maintain high-quality vendor relationships
Speaker(s)
Excellence in Vendor Management
Amanda Lewis
Bristol Myers Squibb, United States
Senior Manager, Regulatory Outsourcing Management
Shifting from a vendor-based RIM model to a full-service in-house Function
Richard Fredericks, MBA
Mersana Therapeutics, United States
Senior Director, Regulatory Operations and Technology
Grappling with Asset Transfers – Regulatory Strategy, Execution, and Considerations
Rohan Mammen, MS
BIOGEN, Canada
Manager Regulatory Submission Planning
Have an account?