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The tip of the iceberg: Domino workshop focuses on the FMD's continued hidden challenges at EGA conference

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Domino Printing Sciences’ serialisation experts were on hand to discuss compliance strategies and patient safety with industry leaders and manufacturers during a lunchtime workshop at the 21st Annual European Generics Association Conference in Berlin last week.

 

Craig Stobie, head of the global Life Sciences team and Bart Vansteenkiste, EU Life Sciences sector manager led a lively session centred around the industry’s move to item-level serialisation in 2018 when the EU Falsified Medicines Directive (FMD) comes into force.

 

Speaking after the session, Stobie said, “It was fascinating to witness the tangible progress of the European Medicines Verification Organisation (EMVO) collaboration at the Conference this year. This, along with the presence of the head of EFPIA at was of great benefit as debates covered some of the most pressing issues threatening patient safety today.

 

The conference also identified some promising news for generics producers. “Much has been written and spoken about the huge challenges associated with moving from batch to item-level serialisation,” continued Stobie. “However, the flip side is that once generics manufacturers have achieved compliance in one market, they are de facto qualified to supply to all 28 EU Member States, opening the way to make affordable medicines available to even more people across Europe.”

 

Bart Vansteenkiste concluded: “One of the most animated moments came during the discussion around national vs individual plant preparation in the countdown to serialisation. It is clear that while many manufacturers are focusing on the challenges of the FMD on a national and European level, they also need to look closer to home – ensuring that any issues in their own factories are addressed. These may be minor now, however item-level serialisation requires a whole new level of scrutiny.

 

“As 2018 ticks closer, manufacturers must be adequately prepared both inside and outside the factory walls if they want to continue to operate within the EU.”

 

Posted on Tuesday 23rd June 2015