News - 1 July 2013 10:00

Global Tracking Regulations Present Challenges and Benefits

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.

The foundation of any tracking system is serialization, which entails affixing to finished drugs a unique serial number and barcode or radiofrequency identification (RFID) that can then be verified at the point of sale. But this basic step is fraught with complexities and variants.

Torben Vogt, life sciences expert at NNIT explains how you prepare for serialization and make use of the benefits. Read the article published online at RAPS (Regulatory Affairs Professionals Society)

Topics

Data, Telecom, IT

Contacts

Tina Joanne Hindsbo

Press contact Head of Public & Media Relations tnjh@nnit.com +45 3077 9578

Sofie Mand Steffens

Press contact Senior Communications Consultant smst@nnit.com +45 3077 8337

Make the most of serialization

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?

19 June 2013 09:00

ISO IDMP is the next after xEVMPD

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.

12 April 2013 09:00

BI tool for smooth submission planning and execution

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.

31 May 2013 09:00

PSMF establishment and maintenance, business as usual?

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).