A few weeks into 2015 and pharma serialisation is clearly gathering pace: January saw the first stage of the US pharma traceability going live, on 13th February, the European Stakeholder Model (ESM) has taken a big step forward with the formal foundation of the EMVO (European Medicines Verification Organisation) and now rumours are leaking out that the publication as well as the adoption of the EU-Falsified Medicines Directive ‘Safety Features’ Delegated Act will take place before the middle of the year. This is important because this sets the tight 3-year implementation clock ticking for EU-FMD compliance which will affect a large part of the portfolio of almost every pharma companies.
Add to that the other deadlines – South Korea, Saudi Arabia, Brazil – that will shortly follow., and it becomes clear that 2015 is the year when pharma companies, be they brand owners, generic pharma companies, contract manufacturers or re-packagers, take action and kick-off their serialisation implementation programme or risk never meeting the compliance deadlines.
We understand that taking the first step to implementation is a challenge not just from a practical viewpoint but also in engaging key stakeholders. It’s why we’ve been speaking about how ready the industry is as a whole and the possibility that some manufacturers won’t be here after 2018.
Overcoming these challenges won’t be easy, but as industry experts we’ve been there ourselves and we know how to start- and more importantly deliver – a successful programme. Now you’ve decided to act we can help you focus on achieving serialisation by breaking this challenge down into a series of steps that focus on sub-goals that are concrete, measurable, time-based and most importantly achievable.
As serialisation experts our highly-acclaimed serialisation training events will help programme managers, team members or indeed anyone within a pharma company, explore and address the key aspects of a manufacturer’s readiness response.
Our next event takes place on the 19th-20th May in Basel, Weil am Rhein. Register today for our unique serialisation training event where we work with you to understand your individual requirements and provide full course notes and valuable handouts.
Interested in serialisation training from the world’s foremost pharma experts but can’t make the next event? We also have an event taking place on the 16th-17th September in the UK email firstname.lastname@example.org to reserve your place today.