The FDA Drug Approval Process conference in London will provide an overview of procedures and requirements for the U.S. drug approval process.
There will be a course on requirements for submission of NDAs, ANDAs, and 505(b)(2) which will specifically benefit those responsible for preparing U.S. registration documents, regulatory affairs personnel and lawyers.
The first of the two-day program will focus on an overview of INDs, data requirements for drug substance and drug product, pre-clinical and clinical testing, and the different phases of drug development. This will include recent changes in the review and breakthrough status, pediatric legislation, financial disclosure, clinical trial transparency and exclusivity and patent declaration.
The second day will focus on identifying the NDA types and understanding ANDA classifications. The day will also touch on how to obtain information from the FDA.
The seminar is scheduled for September 19-20.