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insights LIFESCIENCELEADER.COM APRIL 2014 50 REGULATORY COMPLIANCE records. Whether penalties are applied or not for inadequate attention to EVMPD submissions, the last thing companies want is to fail to deliver against public health and safety improvement targets. However, it is likely that the XEVMPD data will be used for establishing mar- keting authorization holders' pharma- covigilance fees, a subject that is being hotly debated at present. There is some good news, too. The update process is being simplified so that it is no longer necessary to track each variation that is made to a product license. But overall there isn't a great deal to smile about as pharma compa- nies' administration workloads multiply. The only way to lighten the load is to get help to streamline processes, allevi- ate repetitive practices, and drive up data quality. Whether submitting for the first time or resubmitting and updating infor- mation, companies need to be able to extract and send the right content read- ily — and be able to vouch for its quality. Getting this right sooner rather than later will pay dividends though. Over time, the EMA's requirements will only become more stringent. The next iter- ation of XEVMPD — ISO IDMP, likely to become mandatory in 2016 — will take pharmacovigilance reporting to the next level, introducing significantly more data requirements and additional controls over data quality, among other measures. It is expected to have broader geographical application, too, i.e., beyond Europe. So making the effort to achieve compliance now will provide an impor- tant building block for the future. L nal efficiencies. For example, capturing information in a central location means there is a "single place of truth": infor- mation only has to be entered once yet can be accessed readily by anyone who needs it (assuming they have the relevant authorizations) and repurposed in all sorts of different ways. Other operational improvements could include accelerated workflow, improvements to data qual- ity and reporting, easier auditing, and broader information compliance. By smoothing administrative processes, the right software also could help companies get new products to market in better quality and more quickly. DATA QUALITY CONCERNS One of the issues the EMA has been grap- pling with has been the poor data qual- ity that companies have submitted to its central database to date. For a limited period, the agency encouraged pharma companies to input their own categories into the controlled vocabularies used in the medicinal product dictionary. This has led to overlapping fields and duplica- tion of content. As it has sought to clean up this data, the agency has had to consolidate some of these codes, which is one of the rea- sons companies now need to resubmit a lot of content. Going forward, companies will need to ensure that the data they submit is cleaner and more accurate. This means removing duplication and manual entry in internal data capture and manage- ment processes. With eCTD (electronic common techni- cal document)-based electronic regula- tory submissions, validation criteria and tools exist to provide assurance around data quality. It is likely that similar aids and tools will be made available in due course to help ensure clean, compliant data for EVMPD. RESTORING DATA HEALTH Quality control is vital if the goal of increased patient safety is to be met, and any life sciences company that takes pride in its brand will want to pay close attention to what goes into these central firmed, so they have made little prog- ress during the last 18 months. Now that there is no longer an excuse for inertia, companies have a lot of catching up to do. COORDINATION CHALLENGES Although much of the required content already exists in companies, it is widely dispersed and is often captured manu- ally in spreadsheets. The EMA provided a free online data entry tool, EVWEB, to make the process easier, but its param- eters are basic, and use of the tool has resulted in variable quality in the infor- mation that has been submitted. In other cases, any initial sense of urgency soon became diluted once the deadline came and went and organizations realized that there were no real consequences for non- compliance — in that no firm has so far been penalized for noncompliance. But the EVMPD/XEVMPD initiative is a work in progress, and now that stan- dards have been issued concerning the way data must be updated, the EMA is likely to come down more heavily on companies that do not get their data in order. At the very least, this could lead to reputation damage if high-profile brands are exposed as being tardy in their sub- mission activity, especially given that the whole point of pharmacovigilance is to improve consumer safety. FINDING THE RIGHT CURE The only safe way to achieve compli- ance is to have reliable, fit-for-purpose processes and systems in place, which are geared toward clean, easy, and stable data capture, management, and reporting. By doing so, companies not only improve their ability to meet their EVMPD obligations, they also stand to benefit from all sorts of additional inter- Miranda Pothiawala is director and head of software at Samarind RMS. Steeped in knowledge of regulatory submissions and data management in the pharmaceuti- cal and medical device industries, she is also an expert on EudraVigilance and compliance with the EMA's (European Medicines Agency's) EudraVigilance medicinal product dictionary. By M. Pothiawala ARE YOU PREPARED FOR THE NEW EUROPEAN PHARMACOVIGILANCE GUIDELINES? Over time, the EMA's requirements will only become more stringent. 0 4 1 4 _ R e g u l a t o r y . i n d d 2 0414_Regulatory.indd 2 3 / 2 1 / 2 0 1 4 1 2 : 1 9 : 1 5 P M 3/21/2014 12:19:15 PM