Database of Information Sharing (tracking) with the European Medicines Agency (EMA) - Track interactions (meetings, conference calls, exchange of confidential material) between FDA and EMA to better analyze the type of information exchanged and the frequency by several parameters (e.g., pediatrics, oncology, parallel scientific advice, orphan drugs, veterinary medicines, etc.). The database will allow us to refine the interactions to make them more efficient and timely, thereby increasing the public health impact of the exchanges.OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.COMPLETEDON TRACKA. Conduct initial brainstorming and OIP Europe/EMA teleconferences to determine the needs of a searchable database1/25/2010Completed1/25/2010B. Compose first draft of Excel spreadsheet database2/28/2010Completed2/28/2010C. Present OIP/EMA agreed draft Excel spreadsheet to OIP and EMA management and FDA Center international liaison staff for comment and input, as requiredBegin 3/4/2010Completed3/31/2010D. Implement draft Excel spreadsheet database for tracking of FDA/EMA information exchanges5/1/2010Completed4/1/2010E. Identify best practices for information archives from established FDA-EMA Clusters6/1/2010Completed6/1/2010F. Complete full implementation of readily searchable database of information sharing between FDA/Europe Office and European counterparts, for human and veterinary drugs and biologics, devices, foods, tobacco, and combination products (1)N/AN/AN/A(1) Milestone was not completed while this project was tracked in FDA-TRACK.http://www.fda.gov/AboutFDA/Transparency/track/ucm206185.htmFDA-TRACK Office of International Programs Dashboard