On-demand Webcast: Case Study - Bringing Agility and Automation to New Drug Application (NDA) Development

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Learn how to implement new operating processes and business systems that equip small regulatory teams to manage the demands and complexity of major submissions. This case study from Trevena will share how one innovative biotech designed and implemented their internal submissions and RIM capabilities to minimize manual overhead and prepare for growth.

Travena’s head of regulatory affairs operations and R&D IT, Rob Rainer, will describe how he introduced key systems, processes, and partnerships significantly reducing the overall cost of submissions while increasing their speed and turnaround time for both maintenance and major submission types. Rainer estimates they reduced the overall cost burden of their end-to-end submissions process by over 75% by introducing powerful capabilities in the areas of submissions planning and tracking, document management, metadata management, commitment tracking, and regulatory activity reporting. Rainer will share how he significantly reduced the burden on the regulatory team by introducing self-service reporting on the status of planned, in-flight, and completed regulatory submissions, including metrics enabling continuous process improvement.

Learning Levels: 

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

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.  

Learning Objectives 

Upon the webcast's conclusion, you will be able to:  

  • improve visibility into your operations by managing metadata instead of tracking spreadsheets.
  • eliminate redundant steps by getting each area to enter data directly within your RIM system.
  • get people to work within your system rather than around it by tailoring review and approval workflows to the differing needs by area or module.
  • improve your productivity by learning how to be more agile in adopting the new capabilities that come with each release of cloud-base regulatory systems.


Rob Rainer, head of regulatory affairs operations and R&D IT, Trevena