The amount of data collected during the life cycle of a new drug or device spans over many years and will be analysed, combined and reused for different purposes. One of the more important purposes are to successfully submit the data to regulatory authorities to get approval on the market.
Since 2016 US regulatory authorities has required conformance to specific data standards as reviewers need an understanding of the submitted data, to follow the traceability of data points and repeat the analyses performed on the data. This also means that documentation must be put in place for them to navigate the submitted information.
This presentation will give an overview of how a reviewer works and what they expect to be part of a submission, and why it is important to be able to communicate the science of your data.
Johannes Ulander has more than 20 years’ experience from clinical research and development, working for AstraZeneca and other pharmaceutical companies in Europe, responsible for collecting and preparing data for submissions to regulatory authorities. He is an authorized CDISC SDTM Instructor, the required data standard for FDA (US) and PMDA (Japan.)