The European Medicines Agency (EMEA)

Client name . The European Medicines Agency (EMEA)

Sector . Regulatory Authority – Pharmaceutical

Summary comment . Riccardo Ettore, Deputy Head of Information Technology
Summary comment . Communications & Networking Unit, European
Summary comment . Medicines Agency

"With the proper training, end users are able to make changes to FileMaker applications that would otherwise require a full development cycle – you can literally measure developments in hours, days, and just a few weeks (whereas some of our projects last years)."

The European Medicines Agency (EMEA)

FileMaker Forms EMEA's Flexible Rapid Application Development Tool

A decentralised body of the European Union headquartered in London, UK, the main responsibility of the European Medicines Agency (EMEA) is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. Established in 1995, EMEA has used FileMaker from the very start and has, over the years, successfully developed numerous database applications meeting a wide range of requirements – both scientific and administrative.

Client mood board The European Medicines Agency (EMEA) - Client mood board

The Client Challenge

Charged with the responsibility for the protection and promotion of public and animal health, managing data is paramount for the European Medicines Agency (EMEA). The ability to develop database applications rapidly and at low cost, share scientific information across systems, and be able to support daily administration within the organisation for some 500 knowledge workers is essential to its smooth operation.

The FileMaker Solution

An established FileMaker user, EMEA has now upgraded in order to benefit from ODBC connectivity. The Agency operates an Oracle and Java database development environment, and uses FileMaker as a flexible rapid application development tool.

Organisational benefits

  • Rapid development of systems – within hours, days and weeks (as opposed to months and years)
  • Connectivity with Oracle and one-time configuration of ODBC (Open Database Connectivity)
  • All data secured, backed-up and auditable, using FileMaker Server

"Back in 1995, the Agency was very small (around 20-30 staff) and so we didn't have the IT resource that we have now," recalls Riccardo Ettore, Deputy Head of Information Technology, Communications & Networking Unit, at EMEA. "FileMaker is great in this scenario ensuring new applications can be rapidly developed."

Supporting Key Agency Processes

One system in production since the EMEA's inception is a FileMaker database used to process certification requests by companies wanting to import/export medicines. The system essentially allows XML data, entered into an intelligent PDF form by the applicant, to be imported directly into FileMaker. Accurate data capture, storage and retrieval is a vital part of the certification process because this information is then used to create legally-binding documents incorporating detailed information on the applicant and their product.


More recently, FileMaker's flexibility enabled the IT team to develop a solution for processing applications for internships at the Agency. Each year, EMEA takes in around 40 university graduates and, to streamline the process, a PDF intelligent form – from which XML data can be imported – was developed. "Previously, there would have been a pile of student applications 2-inches thick that had to be circulated between 40 plus managers for review," says Ettore. "Now, the entire process can be handled electronically within FileMaker."

Following the success of its internship system, EMEA has extended it to include applications for full employment. Again, a PDF is available for download from EMEA's website and, once submitted by applicants, populates a FileMaker database. Another system being developed will support the Agency's 'pharmacovigilance' network, which continuously monitors the safety of medicines.

A Flexible Front-end

Currently the EMEA is deploying an organisation-wide upgrade to FileMaker Pro 9 (from version 8) – to enable shared access to live data from external SQL sources. "The connection to Oracle was music to our ears and a masterful move by FileMaker," Ettore enthuses. "What makes it even sweeter is that certain projects can be done in the front-end using FileMaker, and then consolidated in the back-end with Oracle, enabling us to share data between systems."

When the Agency first moved to its Oracle/Java environment five years ago, Microsoft Access and FileMaker were classed as legacy systems. However, the flexibility of FileMaker has made it indispensable. "We continue to support and use FileMaker because it makes sense for projects where you cannot justify the much bigger investment and resource-intensive development required to create an application in Oracle and a Java front end," he explains. "We leverage FileMaker for very quick wins, rapid application development and sometimes even prototyping – so a database can be created and moved to a bigger system, if warranted."

The Agency also uses FileMaker Server to share database information across the organisation. "FileMaker Server is brilliant for providing database access via the Web. For seven years, until we replaced it with a Java/Oracle system in 2006, we used it to keep track of more or less 4,000 European Experts by serving a Filemaker web application over EUDRANET, the private network of the EU a drug regulatory authority." The latest version of FileMaker Server supports ODBC (Open Database Connectivity) and JDBC (Java Database Connectivity), making it possible to read from and write to FileMaker Pro databases hosted by FileMaker Server from a variety of external programs and development tools.

Maintaining Healthy Growth

For Ettore, the beauty of FileMaker lies in its ease of use, growth in product functionality, and stability. "Ease of use and development could result in the creation of a database that is a 'dog's dinner' but, fundamentally, when put in the hands of the right person, a system like FileMaker can do wonders in a very short time, giving you quick wins," he says. "With the proper training and with some expert guidance from the IT department, end users are able to make changes to FileMaker applications that would otherwise require a full development cycle – you can literally measure developments in hours, days, and just a few weeks (whereas some of our projects last years)."

For example, a project created in Excel can be imported into FileMaker for creation of an effective database with intuitive GUI (Graphical User Interface) and the ability to share information across the organisation. FileMaker Server enables EMEA to ensure that all data is backed up, secured and can be audited (i.e. who accessed and modified information, and when) – a vital requirement for both EU regulatory authorities and the certification of medicines for import/export.

Flexible Purchasing Options

"FileMaker is not only a flexible, easy to use product, it also offers a choice of pricing options to suit the way in which the Agency works. We chose to purchase a 900 user FileMaker Site License, which means that FileMaker is installed on all our machines as part of our standard build and therefore can be used by all staff at any time to suit them. For even greater flexibility, we also chose to purchase a separate Volume License to enable 150 of our external stakeholders to access our internal systems remotely, further streamlining our business processes," concludes Ettore.

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