EMA in Midst of Website Overhaul, Calls for Industry Assistance

Posted 29 January 2013 | By Alexander Gaffney, RAC 

The last decade has seen an increasing shift into digital forms of communication, submission and information in the regulatory affairs space. Sponsors can now submit applications and submit updates to regulators electronically, and-perhaps most importantly-find the regulations and guidance documents they need online instead of in a library or legislative building. But as those layers have built over time, it has become exceedingly difficult for a sponsor to find the exact information they are looking for. Perhaps not for much longer, if the European Medicines Agency's (EMA) latest project is a success.

It's likely a familiar experience to users of almost any government website: You have something you need to find, but the labyrinth of subcategories, dead links, pages and dead-ends have left you without recourse. The search bar, for all you know, may in fact only respond to secret code last known to the Mayans.

But if regulators have been swift to issue regulations and guidance requiring user testing for many products-medical devices in particular, but also pharmaceutical products with the potential to be abused-they may be considerably slower to subject their own websites to similar testing.

Until now, that is. EMA has announced that it will be seeking to recruit volunteers from the pharmaceutical industry to "help test some new, improved features for its main corporate website, ema.europa.eu."

"The Agency is always looking for ways to improve its websites for key stakeholder groups such as patients, healthcare professionals and the pharmaceutical industry," EMA continued. "With this in mind, it has been working on a redevelopment of some key areas of this website for the last few months."

Those areas should directly benefit those working in regulatory affairs, it said. It is specifically recruiting regulatory affairs, regulatory intelligence, people charged with tracking pharmaceutical guidance documents, and those responsible for online submissions and telematics.

"Volunteers will also need to be regular users of the Agency's websites, although it does not matter if they are new to this role," it explained.

Unfortunately, US users of EMA's website may find it difficult to participate in its testing procedures. Testers will need to be able to attend an in-person testing session in Central London between 11 and 14 February 2013, and the cost of attendance is not reimbursable by EMA. The sessions will be one hour in length and will focus on the end user experience, EMA explained.

Those wishing to participate in the testing should email newwebsite@ema.europea.eu to give the agency details of their job and explain their familiarity with EMA's website.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe