Effective data management is imperative to achieve regulatory compliance with a serialisation programme. Non-standard data exchange and integration methods are seen as one of the biggest hurdles in serialisation compliance.4
In light of the data responsibilities expected within serialisation projects, Pharma IQ consults with a selection of experts on software best practices - data integration and implementation.
Pharma IQ spoke to Mark Davison, Chief Executive Officer at Blue Sphere Health Ltd to gain insight on his experience working with SME pharma & biotechs for serialisation. Also we spoke to Vetter pharma – a responsible CMO for their insight on how peer CMOs optimise their serialisation strategy.
Pharma IQ spoke to Jay Jay Han of Hanmi Pharmaceutical to explore the serialisation landscape in South Korea.
Roger Bate from the American Enterprise Institute estimates that global economy is hit by $10 billion in losses due to counterfeit and substandard medicines alone. Undoubtedly, technology stands as a keystone in a controlled track and trace system. In this eBook we look at the key considerations organisations face in finding the right technologies and focus on the strategies for integration to ensure a successful serialisation project.
Pharma IQ spoke to Jean Marc Bobee of Sanofi to find out about what’s next for the market in terms of serialisation.
In this presentation Christoph Krähenbühl, IS Programme Manager, Pack Coding and Product Security, AstraZeneca discusses product security, patient safety, anti-counterfeiting, supply chain control and coding. He also discussed how AstraZeneca tackles some of these issues.
Sebastien Mauel, Head of Product Security, Merck Serono, shares his insights with Pharma IQ at IQPC's Pharmaceutical Serialisation & Traceability event. Mauel discusses the current challenges relating to detecting counterfeit drugs in the supply chain, preventing counterfeiting at the pharmacy, strategies for successful authentication of pharmaceutical products and the benefits and pitfalls of the e-pedigree approach.
Don’t be distracted by news of a ‘shutdown’ in the American government, some of the biggest news from the pharmaceutical legislation perspective is not related to the inability to pass a budget. The Drug Quality and Security Act will have a bigger impact on pharma.
Pharma IQ presents this interactive one page guide to the Drug Supply Chain Security Act (DSCSA) Implementation Plan
In this article we will discuss publishing the related serialisation information and two of the common serialisation models, Authentication and Track and Trace. Product Information Notification Typically, once product packaging of one or more levels has been uniquely identified, this information, together with other information related to the product and manufacturer is passed to an external agency database.