Systech International Readies EU Pharmaceutical Companies for FMD Regulatory Deadlines
Global Leader in Serialisation Provides Best Practices and Practical Solutions
Brussels, Belgium—(May 16, 2017) — Systech International, a global technology solutions leader for the pharmaceutical industry, is proud to announce its upcoming serialisation webinar titled “The Clock is Ticking: Overcoming the Challenges of Implementing Serialisation in the EU” on 24 May 2017. This webinar is in response to the upcoming FMD deadlines for coding, serialisation, compliance reporting, and verification—as well as the need for flexible, reliable, hardware vendor-neutral solutions to meet these requirements. The new regulations are effective 9 February 2019, giving pharmaceutical companies, their CMO/CPO partners, and others who license pharmaceutical products less than two years to meet an extensive set of requirements. These directives apply to all EU member states, EEA members, and Switzerland.
As its most basic level, the law requires that every prescription drug have its own unique identifier—whether applied in the factory or at the packaging site. That identifier must be stored in a centralized EU database. In addition, the pharmacists or entity that dispenses the drug must scan the product and verify it against the database before it is sold to the patient. The mandate is meant to reduce the number of fake drugs in the market—whether a result of counterfeiting, diversion, or black market activity—and most importantly, to protect patients.
According to Alastair Taylor, Systech’s Director of European Sales, “While the largest global pharmaceutical companies have been working to meet serialisation mandates for the past several years, the current issue is two-fold: (1) small and mid-sized firms, as well as their partners, may not be as well-prepared; and (2) since serialisation solutions include a hardware requirement, some vendors won’t be able to logistically meet the deadlines. For example, if a pharmaceutical company has 50 lines to serialise and only one hardware vendor, they may be at a significant disadvantage for compliance.”
The Systech Difference
Systech’s approach is completely different from other serialisation vendors and reduces both the risk and cost of serialisation. Because Systech is hardware-agnostic, the company can select among multiple trusted hardware partners or retrofit its solution to existing packaging lines. Although Systech has a long history of serialising the largest pharmaceutical companies in the world, many smaller companies need to be cost-focused. “TCO should be an important metric in a customer’s buying decision,” states Andy McLaughlin, Systech’s Director of Global Services in Europe. “Most serialization programs are viewed over a ten-year period, and with Systech the total cost of ownership can be significantly lower than alternative methods. Why? We have experience on thousands of lines. We have more resources than our competitors. We’re already working with top partners. Furthermore, product line uptime is higher with us, so there’s little to no downtime or loss of revenue.”
At the Systech live webinar, Andy will share his experiences developing serialisation implementation strategies, as well as best practices for the European market. The webinar takes place on Wednesday, 24 May 2017 at 4PM CET/3PM GMT/10AM EST. Andy oversees Systech’s European customer programs for its Professional Services team. He is responsible for consistent and scalable delivery throughout the entire project lifecycle, ensuring projects are completed on time, within budget, and with excellent customer satisfaction. Throughout his career, Andy has delivered software solutions to the pharmaceutical, clinical trial, and medical device sectors.