The FDA Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER's primary mission is to promote and protect public health by ensuring availability of safe and effective drugs of high quality throughout the entire drug life cycle. The Center oversees the research, development, manufacture and marketing of drugs.
In order for the FDA to best adapt to the ongoing rapid changes in the drug regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, CDER initiated a major effort five years ago to improve its ability to manage key regulatory data over the life of a drug and to better understand the global drug supply chain at a more granular level.
During this webinar, Shanthi Vigneshwaran, Computer Scientist at the Food and Drug Administration, will share how the CDER has created a 360 view of a drug’s lifecycle, from inception to product. This includes visibility of the global drug supply chain, product ingredients, suppliers, and facilities - bringing them into one trusted view – and empowering the agency to trace any potential harm, save lives, and respond to changes in supply and demand more quickly.
Join us to learn how it’s possible to:
- Gain visibility into a global supply chain across disparate locations and systems
- Address globalization and apply standards in data processes to ensure integrity
- Manage data across complex product lifecycles
