Seminar to outline FMD requirements
15 May 2013
The need for pharmaceutical manufacturers to act now in order to meet the requirements of the EU Falsified Medicines Directive (FMD) will be the key theme of a seminar.
Presented by 3C Integrity managing director, Christoph Krähenbühl, the seminar will demonstrate how there is enough information available for companies to begin their preparations now and that those who delay for too long run the risk of not being ready in time.
The threat of falsified medicines penetrating the European pharmaceutical supply chain is substantial and growing and the FMD has been established as an important step in protecting patients from counterfeit medicines.
While the exact outcome of the Delegated Acts is not expected until next year, there are clear indications of what will be required, in particular the need for all companies to participate in a systems-based, Europe-wide medicines verification process.
The seminar will provide an update on the European Stakeholders’ European Medicines Verification System (EMVS) and examine the options available for establishing effective serialisation technology and emphasising the need for flexibility.
It will also highlight the many other wider preparations that manufacturers will need to implement such as data management, pack artwork, data quality, and internal organisation, processes and communication, both during the initial set up and once the system is established.
“The work we have done with clients to date has already highlighted the need to start early and to be as flexible as possible,” explains Christoph Krähenbühl. “With so much detail to get right, companies must begin preparations now in order to identify unforeseen problems and complexities.”
In addition, as Krähenbühl will point out, there will be huge demand on equipment suppliers which means capacity will be severely strained and could lead to a ‘first come, first served’ situation.
The seminar will take place at 11am on Wednesday 5th June at the Total Processing and Packaging Exhibition at the NEC.
For more information, please contact Sunala Ltd on: Tel: +44 (0) 1942 674440, E-mail: info@sunala.com or visit www.sunala.com.