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Falsified Medicines Directive (FMD)

In this exclusive interview, we discuss the digitalisation of the supply chain, compliance with European Falsified Medicines Directive and TraceLink’s Product Information Manager with the company’s vice president, solutions marketing, Dan Walles. more

Opinion

Colin Newbould, the Wasdell Group, discusses upcoming deadlines and what companies should be thinking about as the scope and requirements of track and trace legislation continue to change. more

Opinion

As the deadlines for the US Drug Supply Chain Security Act (DSCSA) and the Falsified Medicines Directive (FMD) near, pharma businesses should be prioritising the validation of their solutions. Here, Lauren Catalano, Sharp Services, offers guidance more

Opinion

In this article with EPM, Dexter Tjoa, director of Corporate Strategy, discusses why outsourcing is fast becoming the most logical choice for companies who have delayed developing appropriate solutions and what benefits an experienced CPO can bring more

Opinion

In this interview, we at EPM magazine speak with Staffan Widengren, director of corporate projects at Recipharm on the difficulties CDMOs are facing leading up to the European Falsified Medicines Directive (EU FMD) deadline in February 2019. more

Opinion

Earlier this month (9 August) we passed the six-month time point before all companies in Europe will be expected to comply with the falsified medicines directive (FMD). more

Opinion

A partnership has been announced between ACG Inspection (ACGI) and CertiRx (Verinetics) to further enhance traceability and authenticity solutions and strengthen their fight against falsified medicines. more

News

We have now passed the six month point before the Falsified Medicines Directive (FMD) comes into force. In this online exclusive, Mark Davison, senior operations director, rfxcel insists you ACT NOW! Here are six short reflections. more

Opinion

In this online opinion piece, Mark Davison, head of operations in the EU for rfxcel, outlines everything marketing authorisation holders (MAHs) need to know and what is needed for a seamless serialisation process more

Opinion

PCI Pharma Services has announced the installation and validation of its latest comprehensive serialisation system at its manufacturing Centre of Excellence in Tredegar, UK. more

News

As the deadline approaches for companies to be compliant with the new legislation to apply serialisation codes to every applicable pack of product, Gill Wright, design & development director, Cirrus, asks if you are ready for FMD… more

Opinion

In this interview with TraceLink’s Dan Walles, VP Global Solutions following his presentation at FutureLink Munich conference, we discuss automated software validation and how drug companies can benefit from it. more

Opinion

Swiss pharmaceutical group, Helsinn, has revealed it will be investing €6 million at its drug product supply centre (Helsinn Birex Pharmaceuticals — HBP) in Dublin, Ireland, to safeguard its supply chain and compliance with regulatory requirements more

News

After a preview of TraceLink’s second annual Global Drug Supply, Safety and Traceability survey has revealed disparity in terms of readiness for the FMD between pharma companies and CMOs, three experts give us their perspectives on serialisation more

, , Opinion

As the falsified medicines directive is set to come into full force early next year, Christian Taylor, serialisation business consultant, Zetes, looks at the key challenges and practical questions relating to achieving compliance in more detail. more

Opinion

In this online exclusive, FutureLink Munich speaker, Dr Andrew Rut, CEO and founder of MyMeds&Me, discusses how serialised medicine will revolutionise patient safety and engagement as well as adverse event reporting in the coming years. more

Opinion

Adrián Abad Fustero, Supply Chain Director of Medis, will be presenting at FutureLink Munich on the ‘The Virtual Broker: Negotiating Win-Wins with Track & Trace Partners’. In a preview of his presentation, we interviewed Fustero on the role of broker more

Opinion

As the deadline for compliance with the EU FMD gets nearer, Manfred Voglmaier, VP DACH (Germany, Austria, Switzerland) sales, TraceLink, looks at how master data management framework can help businesses meet the necessary requirements. more

Opinion

A new partnership has been formed between Mettler Toledo PCE (product inspection specialists) and R-Pharm Germany (contract manufacturer) to support pharma customers in the implementation of serialisation and aggregation solutions. more

News

As the EU Falsified Medicines Directive (FMD) legislation deadline draws closer, Solidsoft Reply has revealed that the first seven countries to go live with the National Medicines Verification System have chosen its National Blueprint systems. more

Technology

  • Atlantic Zeiser

    Atlantic Zeiser