With less than 630 days after entry into force of Regulation No. 16 of 2016 the European Union’s objective for control and all’anticontraffazione of drugs and is intended to create a new pharmaceutical model. The deadline begins to be compelling, well then made Altea Up to organize in late May in Milan, an event dedicated to take stock of what may be the regulatory changes to a regulation that involves all the players in the world Pharma and especially how it is You can turn them into competitive advantages. “The market is moving very quickly, especially in light of the new provisions, and perhaps not all the protagonists have clear ideas: our intention is therefore to provide a simple view of what can be made available to companies in view of the deadlines, “he stressed in introducing the event Giancarlo Pera, Director Pharma Industry Altea Up . Established in 2016, Altea Up arises from the spin off of the business unit SAP of Altea and the union with two other realities of the SAP world. Altea Up has over 260 skilled and specialized consultants in different areas offer SAP and is recognized by SAP with the Gold level partnership especially in the Pharma sector. In terms of revenues and resources, Altea Up is the first company of Altea Federation , a federation of companies specializing in consulting and development of corporate and innovative software solutions in IT, with a turnover of around 70 million Euros and about 1,000 employees .
innovative and efficient Model
The basic idea is to take this opportunity to give way to the Pharma industry to move from a regulated system to an innovative model and above all efficient, as explained Pierluigi De Rosa, Solution Leader Pharma Altea Up : “We are facing a new legislation which comes into force in February 2019, on which the legislature has not clarified some issues, but requires companies in the Pharma to make important decisions. The underlying themes are serialization, traceability and data integrity, and may seem familiar themes, but now the approach is different, because it involves the transformation of a regulatory compliance into a competitive advantage. It is therefore essential to keep in mind that you can not address these and other issues in the pharmaceutical industry not think of a real and true renewal and transformation processes.
Towards the Pharma 4.0
The scenario that is taking shape in the coming years will see the companies operating in traditional industries, such as pharmaceuticals, obliged to introduce new increasingly innovative processes in order to follow the evolution of the market, not only in terms of regulatory changes, but the processes and products, more and more advanced. Each company will have to interpret the future and identify the best solutions to be adopted. It will be possible to choose whether to simply adapt to the requirements, or decide in an innovative way to face the new constraints, identifying and implementing new processes and solutions. This route will make it necessary to have data in developed and effectively managing information from systems, many of which are already in the company.
The introduction of new technology on the lines, if not governed appropriately through the implementation of new technologies, will mean an inevitable risk of an increase in set-up times on the lines of what has occurred. With interventions of innovative type, where the various technological components communicate with each other, will, however, be able to get different results. You can manage the necessary adjustments, to intervene with appropriate diagnostic reports of predictive maintenance, exchange the necessary information while minimizing the latency with a reduction of set-up times of the machines. The application of technologies Industry 4.0 implies the need for performance and security of the infrastructure, depending on the increase in the volume of data to be processed and manage business continuity.
In the various interventions that have taken place during the meeting, characterized by broad participation and aimed particularly at managers of pharmaceutical companies and drug distributors, the opportunities offered by technology starting from the Serialization were analyzed.
In particular, it analyzed the SAP ATTP solution (Advanced Track and Trace for pharmacuticals), able to support pharmaceutical companies in adapting to specific requirements on serialization and traceability for anti-counterfeiting of pharmaceutical products. Not only that the pharmaceutical industry is one of the most advanced sectors in the digitization and use of new business models as part of Industry 4.0. Indeed it was also talked about investment incentives: thanks to the extension of the super-depreciation for material goods of 140 percent and the introduction of hyper-amortization at 250 percent for investments in goods 4.0, the pharmaceutical sector could benefit from tangible aid.