Who We Are:
The Office of Computational Science (OCS) drives the modernization of CDER’s scientific review process through the implementation of tools, services, and training to enable reviewers to apply their expertise to information. We provide CDER reviewers innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, tools, and training.
What We Do:
- Enhance the accessibility of data, reducing data integrity issues, and supporting robust data governance through improved coordination and prioritization of CDER’s scientific computing plans and activities.
- Engage stakeholders in developing and delivering effective tools, technologies, services, and training to enhance their ability to meet CDER’s mission.
- Apply advanced technologies to enhance review transparency, efficiency, consistency, and predictability.
- Provide access to quality data, targeted tools, and services that support the evaluation and analysis of study data in regulatory applications.
- Innovate to enhance reviewer efficiency and effectiveness.
Immediate Office (OCS-IO)
Office Director: Lilliam Rosario, Ph.D.
Deputy Director: Isaac Chang, Ph.D.
Division of Regulatory Review & Research (DRRR)
Acting Division Director: Jose Delgado Donayre, M.D.
Division of Tools Technology & Innovation (DTTI)
Acting Division Director: Sanjay Sahoo, MS, MBA
- Office of Computational Science Supports the Regulatory Review Process
- JumpStarting Drug Review
- Scientific Collaborations
For more information, contact Office of Computational Science.