| Chiara Grimaldi and Stefan Harwart of BearingPoint argue that the right technology streamlines compliance initiatives and boosts operational efficiency
The global nature of pharma has opened its share of doors on both sides of the laboratory. Patients the world over gain access to the best the world has to offer, whilst at the same time the bottom line benefits from a wider distribution net. Everyone’s happy, right?
Distributing cross-border has never been so complex, and with different regional authorities requiring different standards of information delivery, companies find that seemingly benign gaps in communication can give way to painful regulatory pitfalls.
This is particularly relevant to artwork and labelling, for which each country has its own requirements and procedures. There is no central process to guide compliance efforts, and until recently the industry was heavily reliant on paper trails to track marketing materials. This was a tolerable burden when pharma companies were not quite so large and not quite so global. But as the biggest players expanded their networks, the importance of closing gaps has been elevated to the highest level.
As issues with artwork and labelling are identified, companies must take a long look at how they approach changes to the material and resolve these crippling gaps in communication and compliance. Technology advances in data warehousing and change control now make it possible to approach the problem with greater sophistication, yielding greater control and greater return on investment (ROI) for the short- and long-term. Ten years ago, the benefits that are achievable through more streamlined current technology were virtually inconceivable. |
