Sponsored Webcast: Streamlined Submission Management for Emerging Sponsor Teams (On Demand)
Regulatory organizations play a crucial role in a sponsor’s success — but small and scaling teams are often challenged by budget and resource constraints.
As a result, too many regulatory leaders at emerging sponsor companies are left to manage their team, documents and submissions with a patchwork of do-it-yourself systems and processes.
In this educational session, Marissa Berry, PhD, RAC, owner of Embee Consulting, and Kivo CEO Toban Zolman will share how they build and scale regulatory operations with sponsors using modern project and collaboration management - dramatically improving efficiency and effectiveness.
The presentation will include best practices and lessons learned in areas such as:
- Regulatory team management — how to structure and manage collaboration across internal and external teams
- Leveraging partners — making the most effective use of regulatory consultants, writers and publishing services at each step in the submissions process, and as your pipeline scales
- Process automation — using tools and platforms to improve efficiency and bandwidth, without introducing compliance risk.
- Scaling cost-effectively — how to manage the workload as a pipeline expands from two active programs to 20… without 10x the budget.
Registration Fees & Deadlines
- Manage and scale an efficient regulatory function, even with a constrained budget or team
- Make effective use of expert partners and technology platforms throughout the submission lifecycle
- Apply modern project management and collaboration tools to accelerate timelines and avoid delays
Who Should Attend?
Regulatory Affairs, Regulatory Operations, or Regulatory Consultants who currently work or plan to work with emerging sponsors.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
