Yes, quality has its price, and yes, the global demand for drugs and medical devices is high. For these reasons, Life Sciences is an attractive area for some market participants to play a different and dangerous game offering falsified products.
The drivers for this behavior are sometimes lower price; sometimes higher margin. Either way, for patients and the concerned companies, this is more than just unpleasant. The recent scandal of PIP breast implants in Europe and an open letter of John J. Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America illustrate how severely counterfeit drugs and medical devices can impact health – and unfortunately, there are many more cases out there.
In order to combat counterfeiting of drugs and medical devices and to increase security, new serialization regulations in life sciences around the world are being established. The unique device identifier and the Drug Safety Quality Act are prominent examples, but they are not the only ones. Complying with all existing and upcoming local regulations in the rapidly changing world of serialization is complex.
Preparing for the new set of regulations in a timely manner for each region is challenging. Should life sciences companies start now and try to interpret the rough guidelines that are already available? Or should they wait until more details are clear and implement very fast at a later point of time? This won’t be easy, as they need to integrate with suppliers, contract manufacturing organizations, warehouses, plant shop floors, wholesale distributors and other third parties. How will life sciences companies validate and monitor all serialization activities? And how can they efficiently manage the massive data volumes associated to all this?
We would like to discuss with you different approaches on how to secure patient safety and how to put serialization into practice. Meet us at SAPPHIRE NOW at the open microforum discussion “Maximize the Quality of Drugs and Medical Devices Efficiently in Real Time”, June 4, 2014 at 3 p.m. at IN137 and at our Life Sciences Expert Table IN 113! We look forward to seeing you.