With only three years until the EU Falsified Medicines Directive comes into force, industry experts stress there’s no time to waste
Industry experts have raised concerns many contract manufacturers do not have enough practical knowledge about implementing a serialisation strategy, despite there being only three years to go until the EU Falsified Medicines Directive comes into force.
The observation comes as Optel Vision, TraceLink and Be4ward are inviting CMOs to attend a top level serialisation seminar at the Sheraton Skyline at London’s Heathrow Airport on 30 March, to gain first-hand knowledge of pro-active strategies they can apply to their own track and trace programmes.
Optel Vision CTO Jean-Pierre Allard says a lot of CMOs do not know enough about the EU FMD, and those who have done the research have discovered it’s a complex process that has an impact across all company departments, whether IT, production, logistics, validation, quality control and more.
“Implementing a serialisation strategy is often quite expensive and as CMOs are usually small companies, the consequences of a wrong investment could become critical for their business. These concerns are often why many wait until the last minute to start the process – but what they don’t know is it takes months to implement such a complex process and they should start sooner rather than later,” says Jean-Pierre Allard.
“This seminar we have organised with TraceLink and Be4ward is specially designed for contract manufacturers who need to start their serialisation programmes in order to be compliant.”
Be4ward VP Stephen McIndoe says very few CMOs have actually finished or even started implementing a serialisation strategy, due to waiting for the delegated act to be officially published in its final release.
TraceLink Director of CMO Business Graham Clark says, “As we talk with the industry, the most common concern we hear is the lengthy period of 8 to 10 months that it can take to integrate just one pharmaceutical manufacturer with a CMO. Because only a few of these projects can take place simultaneously, achieving 100 percent integration with a point-to-point infrastructure will take years and the costs will be astronomical. In the upcoming EU serialisation seminar, we’ll discuss the specific business implications for all pharmaceutical manufacturers that must integrate with their CMO networks.”
“The main challenge for CMOs is they often have multiple customers. Each of them have different requirements and adding serialisation on top of this can be hard to manage. Then there’s maintaining a maximum Overall Equipment Efficiency (OEE), as adding inspection and tracking equipment on a line can drop the line speed and impact on company profits. Space maximisation is also very difficult to manage as production line machines can take a lot of space. This seminar will address these challenges and more and give CMOs all the tools they need to be track and trace ready.”
The seminar will feature strategy based sessions from industry experts who have first hand experience with implementing successful serialisation-ready projects. This includes talks from Optel Vision CTO Jean-Pierre Allard, TraceLink Director CDMO/3PL Business Graham Clark and Be4ward Vice President Stephen McIndoe.
Speakers and session times:
- Aladin Alkhawam, Packaging Director, Par Pharmaceutical – Keynote speech: Implementing a serialisation pilot project.
- Philip James-Bailey, Industry Development Manager, GS1 UK Healthcare – Session 1: Regulations, Requirements and Standards for Europe.
- Stephen McIndoe, Vice President, Be4ward – Session 2: Developing a Serialisation Strategy
- JP Allard, Chief Technology Officer, Optel Vision – Session 3: Packaging Solutions focusing on CMO Specific Track and Trace Packaging Solutions, Roll-out experience and Learnings.
- Graham Clark, Director CDMO/3PL Business, TraceLink – Session 4: Pharmaceutical Serialisation: Onboarding Your CMO Network.
- Roundtable Discussions – Session 5: Facilitated by moderators
For more information about the event, full agenda details and to register your interest please visit http://www.serialisationcmo.uk/