Two former AstraZeneca serialisation specialists have launched an intensive training program to guide pharma companies through the legislative and practical requirements for the forthcoming EU Safety Features regulations that form a key part of the European Union’s Falsified Medicines Directive (EU-FMD).
Industry experts Christoph Krähenbühl and Ian Haynes of 3C Integrity, a specialist pharma consulting company, have amassed years of experience in the practicalities of traceability, from designing and implementing product security through to coding and serialisation solutions.
Their focussed training events will each be run over two days, include a mixture of presentations and interactive workshop sessions and will equip participants with the skills and key tools necessary to start up or validate their company’s serialisation readiness programme.
The training centres around a structured curriculum designed to provide companies with a sound understanding of the requirements and challenges of these complex programmes and empower them to hit the ground running for their successful project implementation ahead of deadlines.
“We’re encouraging pharma companies to develop this awareness as soon as possible, since there are currently a concerning number of decision-makers in the industry that are still procrastinating over implementation,” says Christoph Krähenbühl, managing director of 3C Integrity.
“Recent updates from the European Commission have created the impression that the deadline for compliance with the safety feature legislation in the EU is still uncertain, but this is a complete misreading of the situation; it is as good as certain that the date for compliance across the EU will now be 2018.
“We have, unfortunately, seen a number of tier 2 and 3 companies losing engagement again, viewing the manufacturing and supply chain element as secondary to research and development.
“However, the risk of leaving implementation much longer is far greater, since pharma companies now need to face the possibility that they can no longer supply the European market with their products – this could potentially mean a loss of 80% of their sales volumes - and therefore almost certainly the loss of the business.
“We are therefore urging all organisations, especially smaller pharma companies and contract packers, to begin developing a clear plan for getting their manufacturing operations ready to remain in full compliance of legislation.”
3C Integrity’s pharma serialisation training course will address every aspect of a manufacturer’s readiness programme, including analysis of key legislative requirements, the full technology stack, vendor selection and management, compliance and CSV considerations, serialisation case studies, costings and implementation.
Delegates will develop a solid understanding of the key components of their readiness program, advice on how to implement their project, and a clear idea of how to scope the serialisation project requirements for their organisation.
The next training will take place at the Vitra Campus in Basel, Switzerland, on 23 and 24 September 2014, and spaces are limited.