Questions & Answers What is “READY! for Article 57°? READY! (REgulatory Affairs DiarY) is 2 web-based solution for pharmaceutical companies to collect, check, ccsubmit mandatory data for all their products for human use to the EMA according to the legal notice on the implementation of Article 57, READY is a complete solution for managing your regula- tory affairs:it’sa product database; manage yourregula- tory activities; track electronic submissions, store regu- lated documents, and can be used as an archive. Another essential part is project management with activity reporting & planning. The solution can also be used for veterinary and other products. READY will help youcollect and submit mandatory infor- ‘mation until July 2° 2012 and help you identify changes to your products to be submitted within 15 calendar days after variations have been approved. What is xEVPRM? XEVPRM (eXtended EudraVigilance Product Report Message) is a specification for electronic submissions for medicinal products for human use published by the EMA in July, and with Further updates in September 2011 Document management system Shared Various disks databases [6 acl ecrD tT sce! FY pis sess [xg] 0 99) vans oe Consultants Gps SS u x ae GD ===» Ema How can READY! be used? READY! is a comprehensive solution, butis still easy-to- use, Their intuitive web user interfaces helps users to search and navigate among lists of products, insert data, and allows necessary inputs of mandatory fields for each authorised product. READY! makes automatic checks about the validity of data, and informs user about data Which stil needs to be collected and submitted to the EMA. What is the technology behind READY? READY! is built on Microsoft NET and MS SOL techno- logy and works on any web browser. What about existing information in spreadsheets, tracking tools, document managements systems, and databases/applications, including Sharepoint and Documentum? READY! will help you to access existing information about your products, You will be able to re-use it in the most efficient way, reducing the time needed to create the list of your products with necessary details. READY! also enables the exporting of data into Excel spread- sheets for the manual input of data by affiliates and partners. The data can then be checked easily in spreadsheets and uploaded back into READY! when the work is finished. ©2011 Nanokinetik = Regulatory Affairs READY! for: ord + Product database For He, Activity management te. + Planning & Reporting BO | Bamaoes Bae nck 7 Camond Svs Lon ECV 9 Unteigon Vnmteninhcon Choowetnetcan | 1 Pharmacovigllance Quality Assurance Manufacturing(READY!) for Article 57 What is so special about READY? READY! is.a solution specifically built to increase produc tivity in collecting and managingregulatory and pharma- covigilance data The focus is on re-using information for similar, autho- rised products. A typical example is re-using /sharing identical information among nationally and MRP/DCP registered products with the same formulation. By doing, this the same data does not need to be inserted for each separate authorised product, but only once and can then be re-used on similar products. The resultis a significant reduction of the time and staff needed to collect and maintain information to comply with requirements, How do you foresee data collection about medicinal products? This is the central focus of our solution. The solution contains a database where you can collect all necessary information according to the xEVMPD granularity. Initially you have to create a list ofall products that are authorised or registered in the EU. Then you have to collect the available data about these products manually or fromother systems. Once you have the data it can be analysed to find out what is missing. READY! should be integrated and synchronised with your existing databases and other reliable IT systems. This is necessary because the data from document management systems, portals, etc. and other information can change ona daily basis. What happens after 2nd July 2012? After July 2012 you will need to automate the change management process: missing data or variations should create triggers which will automatically inform responsible people to provide the data. If the datais stored in READY! the system itself will know about the triggers (part of our solution in also planning and handling regulatory activities, including variations, which eventually trigger the xEVMPD submission) Users will then update the information and an xEVMPD message will be created. Another part of the solution is the versioning of all records to identify changes and to create an audit trail. This feature lets you know exactly from which version of the product the message was created, and by whom it was approved. Why should you start using READY? The industry has an immense task ahead to identify, collect, collate, and submit data before the July 2012 deadline. The sooner you start to address the identifica- tion of data the more likely you willbe ready to process it ontime. READY!is an out-of-box solution which can be installed very quickly, and users can start collecting the data immediately. ‘Are there any services available in connection with the solution? Yes. We have a team of experienced IT specialists who can help analyse your current situation and help integrate our solution. In addition, we have at your disposal access to experienced regulatory professionals who canhelp analyse your regulatory processes, and find the best match between the existing and future setup of your current T technology and processes. Are you READY? NANOKINETIK® Nanokinetik Ltd, 5-7 Cranwood Street, London ECIV SEE, United Kingdom, W:wwrw.nanokinetik,com, E:info@nanokinetik.com 2