Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization.
ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. ISO IDMP will transform your regulatory IT strategy.
Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).
Regeringen har fremsat et mål om, at 80 procent af den skriftlige kommunikation med borgerne i 2015 skal være digital. Søren Skaarup, der er erhvervs-ph.d.-stipendiat og projektansat hos NNIT, forsker i, hvordan borgerne oplever den digitale kontakt til det offentlige og i, hvordan man kan etablere et velfungerende digitalt samarbejde mellem borger og myndighed.
Skitserne til en ny fase af det digitale Danmark ligger på tegnebordet. Det er en vision, der indbefatter velfærd og vækst. Og selvom digitaliseringen handler om så meget andet end netop it, så er der en række digitale grundsten, der skal være på plads for at understøtte visionen. NNIT er en af de virksomheder, der er med til at levere de digitale grundsten.
”Det er en fantastisk tid, vi lever
Regulatory approval for pharmaceutical products can be difficult to obtain, not least because the submission process is often slow and prone to errors. Thomas Svendsen and Peter Noes of NNIT tell World Pharmaceutical Frontiers how regulatory teams can use a business intelligence tool to monitor submission status and hasten time to market.
Change is afoot for pharmaceutical companies, with new serialisation legislation on the agenda. To help stem the problem of drug counterfeiting, they will be required to adopt a unique serial number labelling system and adapt their business processes accordingly. How can companies derive real business value from the investments they are now required to make?
Meet the team who work behind lock and key at the data centre. You can hear a major customer’s views on working with us. You can read about Peter, who organises a race to raise funds for vulnerable minorities in Vesterbro. And much more.
Dine kerneprodukter vil med garanti blive kopieret, og det kræver et modtræk, hvor du skal bruge it offensivt. Her kan du få ideer til hvordan.
Tillad mig at komme med en tilføjelse til it-branchens uendelige liste af akronymer: CPOF: Critical Point of Failure – det er det sted hvor fejl har den største indvirkning og umådelig vigtigt at kende for enhver, der leverer it-services.
Der er penge at spare ved at lægge applikationsudviklingen i lande som Kina og Filippinerne. Ved at gøre det gennem NNIT får kunden samtidig en leverandør med branchekendskab og lokal tilstedeværelse.
Read about the general international growth strategy, the importance of our life science focus and about how we go to market – known as 1-10-100. We have also checked in at our offices in both NNIT China and NNIT US to see what international growth means there on an everyday basis. What do our international customers say?
