We are thrilled to announce the upcoming milestone in our journey – the 5th Annual Quality Management Event which is held this year together with our valued host: Boehringer Ingelheim!

As a dedicated Life Sciences consulting company, we have always believed in the power of collaboration and the sharing of knowledge. This event serves as a platform for professionals like you to connect, exchange the latest insights from individual projects, and share invaluable experiences from the real-world usage of various quality management systems.

Event Highlights:
Date: Thursday, 19^th of October 2023
Time: 08:45 AM – 04:15 PM (CET)
Location: Boehringer Ingelheim - Binger Straße 173 - 55216 Ingelheim am Rhein

Why Attend?
This event isn't just another conference – it's an opportunity to be part of a vibrant community that is committed to raising the bar for quality management. Here's what you can expect:

Uncover New Strategies: Discover cutting-edge strategies that are shaping the landscape of quality management. Our lineup of expert speakers will delve into key trends and innovative practices that drive results (e.g.: Practical use of AI, Just in Time Learning).

Project Insights: Gain firsthand insights into real-world projects from professionals who have successfully navigated challenges and achieved remarkable quality outcomes. Learn from their triumphs and lessons learned.

Networking Opportunities: Connect with like-minded peers, industry leaders, and potential collaborators. Our event fosters an environment where meaningful connections are made, opening doors to future partnerships.

Interactive Workshops: Engage in interactive workshops that allow you to apply newfound knowledge directly to your projects. Our hands-on sessions are designed to be practical and actionable.

Q&A Sessions: Get your burning questions answered by our panel of experts during dedicated Q&A sessions. Benefit from their deep expertise and varied perspectives.

How to Participate:
To be part of this transformative event, simply register via the following link Register Here for more information. Space is limited, so don't miss out on securing your spot!

Mark your calendars for Thursday, 19^th of October 2023 and get ready to immerse yourself in an event that promises to inspire, educate, and empower. We look forward to welcoming you to our 5th Annual Quality Management Event at Boehringer Ingelheim!

We are thrilled to announce a new partnership between Userlane and MAIN5.

MAIN5 is a leading Management Consulting firm in Life Sciences focused on strategy, processes, and solution consulting in the regulated R&D – particularly in Regulatory Affairs, PV and Quality Management. The holistic approach, which places the primary focus on the route to the digital future and the involvement of people, is also used to implement complex visions and ideas for leading companies in the pharmaceutical industry.

MAIN5 strives to deliver comprehensive support to their customers, from vendor selection, implementation, to ongoing training and support for GxP relevant computerized systems. By partnering with Userlane, MAIN5 is expanding their capabilities in the realm of digital adoption and empowering their clients to navigate the complexities of digitization and cloud transformation. Userlane’s innovative platform brings them one step closer to their vision of revolutionizing traditional and laborious SOP and application training methods.

“We are excited to introduce meaningful and role-based ‘just in time training’, replacing inefficient practices and driving efficient knowledge transfer within organizations.  Furthermore, we recognize the immense value of Userlane beyond training alone. Its functionality extends to live systems, providing users with real-time assistance when they need it most. This valuable tool enhances user experience and ensures seamless productivity within the digital environment.”
Sabine Gölden – Principal Consultant, MAIN5

With Userlane, MAIN5 is poised to deliver enhanced solutions and support to their joint clients, reinforcing their commitment to excellence in the life sciences industry. Together, MAIN5 and Userlane embrace the current and future challenges of training and education in the pharmaceutical industry. We look forward to a successful partnership that will propel our clients towards greater success in an increasingly digital world!

In the strictly regulated pharmaceutical industry, product quality determines long-term success. It is estimated that quality assurance and the cost of remedying defects lies between 20 and 30% of the total cost. Up to a quarter of production staff in the pharmaceutical industry work in quality assurance and their numbers are on the rise. This has dramatic consequences for companies that are under increasing cost pressures. However, product quality can be significantly improved through professional e-learning that clearly conveys the knowledge employees need to perform routine activities properly and without error.
Language boundaries and fluctuating staffs are major challenges in meeting this task, especially for companies operating on a global basis.

The latest figures from the European Federation of Pharmaceutical Industries and Associations (EFPIA) show that more than five million people work in the pharmaceutical industry worldwide. The number of production-oriented jobs has increased by 22% in the past ten years. At locations producing sterile forms of pharmaceutical, 20 to 25% of these work in quality assurance; at plants making non-sterile forms, the figure is 10 to 15%.
In most cases, these employees are only being trained on the basis of standard operating procedure (SOP) documents.

Ideally, these documents serve two requirements:

1. meet the regulatory requirements for audits

2. clearly provide employees with the knowledge they need to perform their routine activities properly and error-free.

This poses a particular problem as the pressure from legal requirements continues to grow. Most SOP documents therefore meet the first requirement very well, using the verbiage used by the auditors, as revealed when 94 experts from the industry were interviewed for the MAIN5 study "Pharma Insights 2019." 70% of them believe that the SOPs of the pharmaceutical industry are so incomprehensible because of the way they have evolved without an eye to good, meaningful communication practices. 65% believe that they are primarily focused on audits. Only 8% of the respondents consider these processes and training to be future-oriented.
This confirms that the second requirement for SOP documents is mostly being neglected. Production staff will usually find it hard to find the relevant content at a glance. This comes at the expense of learning success. Formally, it appears that employees are well-trained, but their actual understanding of the content often falls by the wayside. This just results in pitfalls that they may very well fall into.

Quality defects lead to high costs
Since 2010, the number of drug recalls has almost doubled, according to figures from the Federal Institute for Drugs and Medical Devices (BfArM). At the same time, the amount spent on personnel to eliminate these defects has climbed to between 20 and 30% of the total costs.
Employees, especially those working in production, need access to a learning system that enables them to carry out all of their routine tasks reliably, correctly, and without errors.
Modern e-learning modules offer an excellent set of tools for this purpose. Once created, they will save additional staff costs, ensure consistent quality of the training content, allow individuals to learn at their own speed, and enable a deeper understanding of the content. Even with high employee turnover, they can be used at any time. At an advanced level, training outside of real production can be done using "virtual reality."
E-learning with a focus on a deeper understanding of the content is not a trivial challenge, however.

Learning with pleasure instead of red tape
The experience with current major projects shows that e-learning can be very successful, but also requires a lot of work.
In the age of YouTube, employees around the world have become accustomed to receiving instructions and training for all situations in a skillful and effective manner. They increasingly expect this same high standard on the job. For many of them, this may be the only way to reach them didactically. Providing clear, audiovisual demonstrations of learning content also overcomes many language barriers.
On the contrary, audit-focused learning content is text-based and just seems to be a lot of red tape.
For effective e-learning, it is not enough to ask existing specialists to pass on their knowledge. Rather, this information must be visually and audibly presented in an easily understandable and appealing form (learning from sense of duty is always less effective than enjoyable learning).
E-learning that follows best practices has proven to be a very successful form. It should be interactive, easy, and with individual modules of 20 to 40 minutes duration. The special software required to create these formats should be selected according to customer requirements. Templates are thus developed that provide a basic framework for the content and motivate learners in an appealing way. These templates also make it easier to quickly create additional training sessions without the need for special IT skills.
The time gained can then be meaningfully used for the didactic processing of the content. In the future, the topic of training through e-learning will require more management attention and sufficient financial support from the company.

Choosing the right target group
With the introduction of effective e-learning, one must also correctly identify the target group. This must meet the regulatory requirements, but must not go too far. On the one hand, training for employees who cannot do anything with the content in their day-to-day work is not only useless, but will cause general training fatigue and unnecessary costs when they are kept from doing their regular jobs. On the other hand, if too few employees are trained, this can lead to compliance problems.
It is often not possible to determine the target groups only on the basis of employee job descriptions, because, in most cases, they are only a static representation of the organizational structure. It is different when companies describe their processes in the form of processes, process roles, and responsibilities. Because processes reflect the day-to-day work of companies, they can make it easier to identify who ought to have what training.
Effective e-learning for the right target groups not only can significantly improve product quality in the medium term, it can also be a positive experience for employees – all in the company's own interest.

The Zwickau Nephrology Center was founded in 1993 as an internal medicine clinic, including a dialysis center with 17 dialysis stations. Today, over 200 hemodialysis patients are being treated at 55 dialysis stations and there are three additional dialysis stations for patients with hepatitis. The practice is run by nephrologists Dipl.-Med. Heike Martin, Chair of the Association of German Kidney Centers (Verband Deutscher Nierenzentren e.V.), Grit Müller, Dr. Alexander Sämann and Sebastian Höhne. Patients are looked after by nurses and another internal medicine specialist. The practice employs a total of 60 staff members in its two clinics.

Imperfect processes
The routine work of a dialysis clinic runs like clockwork, with patients changing over according to a certain rhythm. Current statistics show that throughout Germany one dialysis nurse looks after six or seven patients, whereas in the Zwickau center the nurse-to-patient ratio was around one third below the existing norms. In spite of that fact, the staff members felt overworked, which caused recurring dissatisfaction. Under these circumstances, Heike Martin took a bold innovative step of bringing into play an external consultant - namely, MAIN5 - a consulting company with a focus on health economy and pharmaceutical industry. It carried out a preliminary analysis and, more importantly, spent two days in the practice. "We spent two days in the practice with the team and analyzed the personnel situation, processes and technologies. Besides data collection, we prepared outlines of the practice and included in the final analysis the overarching processes that do not take place every day. The key factor for us was getting an accurate view of the value streams in the day-to-day operations of the practice“, explains Dr. Adam Sobanski from MAIN5. Each dialysis lasts between four and five hours and is carried out in two or three shifts. At midday, not only is there a changeover of patients, but also a change of nursing shift, which means that for a short period of time the staff is doubled. "The main focus of our performance improvement plan was to involve our staff members in the analysis and consulting process rather than simply ambushing them with new processes“, says Dipl.-Med. Heike Martin. A workshop at the start of the collaboration ensured a high degree of acceptance among the staff members and their involvement in the process. For MAIN5, this concept is the only correct approach – as process optimization seldom works without getting people on board from the start.

40 percent overlap of staff
During the analysis, it became clear that a temporary overlap of personnel was causing problems in the process. "The fixed clocking on and off of patients and personnel meant that at shift handover there could be more than 40 percent overlap of staff, which resulted in the direct opposite of the desired effect: instead of working faster and more efficiently, the staff members began taking the work out of the hands of their colleagues“, says Dr. Adam Sobanski from MAIN5. In addition, some processes were extremely time-consuming – including changing the filters of the dialysis machines. The wide range of dialyzers in use put the staff members under a lot of organizational pressure, which was reduced by standardization while maintaining the same quality. Both stock keeping and ordering were also significantly simplified due to this change. Another bottleneck - the monthly laboratory testing of blood values - was also resolved by the comprehensive consulting and analysis processes. Blood samples used to be collected monthly on two fixed days, packaged and sent to a specialist laboratory. The resulting stress was considerable. Another stressful situation occurred when the values were communicated back from the laboratory and had to be transferred to the patient data sets. Instead of this block processing, blood samples are now being sent off as part of the daily workflow throughout the month, eliminating such peak load periods.

Better distribution of staff
The solution to the personnel situation required new service plans as well as further extensive workshops aimed at getting the staff members in the practice involved here too. The goal for the management was not to reduce the overall number of employees, but to redistribute the staffing and, therefore, to tap into previously unused potential. "We can do even more for our patients and that was our aim: to fill the resulting free time with other activities that offer our patients direct added value“, says Dipl.-Med. Heike Martin. These include BIA measurements to test body composition and other valuable services. In fact, the results of the analysis also brought a palpable sense of relief and understanding among the staff members - there were no other serious reasons for lack of efficiency than the unfavorable staff distribution. As well as the service plans, the changeover times of patients were also adjusted. Previously, the changeover was scheduled during the lunchtime within a 30-minute window – which rarely worked. First, most patients were fetched and carried by transport services such as the Red Cross or the Workers' Samaritan Federation (Arbeiter-Samariter Bund); secondly, for some patients it takes longer to get back on their feet after dialysis treatment. By extending that time window to 70 minutes, not only was the traffic congestion outside the practice reduced, but also the staff members could allow their patients to stay at the medical center longer and take their time to recover after dialysis treatment.

New processes for the practice
Unlike the pharmaceutical industry projects, in this case the focus was not on a new system landscape with document management or pharmaceutical audits, but on the direct process optimization between practice personnel and patients. "This is unusual in the project business. However, it is an obvious example of how significant the optimization potential can be within a practice. Besides the beneficial change of the staff situation, we also reached a remarkable business performance improvement. And this successful experience can be transferred to other practices and medical disciplines“, explains Dr. Adam Sobanski, partner of MAIN5 and directly responsible for the project.

Frankfurt, November 21, 2019 – In the strictly regulated pharmaceutical industry, product quality is decisive. Almost a quarter of the production staff in the pharmaceutical industry works in quality assurance – the trend is rising. It is estimated that spending on these personnel and remedying quality defects is between 20 and 30 percent of the total cost. Since 2010, the number of drug recalls has almost doubled, according to figures from the Federal Institute for Drugs and Medical Devices (BfArM). So problems exist in the application of quality assurance systems.

"We find that SOP documentation is almost entirely tailored to audits. For the employee, however, their contents are usually too complicated and are hardly suitable for training," says Dr. Adam Sobanski, MAIN5 partner. The consulting firm specializes in complex A-Z projects in the pharmaceutical industry and advises companies on the path to more effective employee training. "Ideally, an employee should understand what an SOP is about when they first read it," says Sobanski. "Employees, especially those in production, need to understand how to carry out routine activities correctly and without errors."

Modern e-learning modules offer an excellent set of tools: Once created, they save additional staff costs, ensure consistent quality of the training content, enable individual learning speed and can be used at any time, even in the event of high employee turnover. At an advanced level, training outside of real production can be done in "virtual reality".

Study confirms audit focus
The industry is generally very focused on audits, according to the MAIN5 study "Pharma Insights 2019": 94 experts from the pharmaceutical industry were interviewed. 70 percent of them believe that the SOPs of the pharmaceutical industry are so incomprehensible because historically they have grown. 65 percent believe they are primarily focused on audits. Only eight percent of respondents consider these processes and training to be future-oriented. Here is where the biggest challenge lies. "The experience of the current major projects with our customers shows that e-learning is very successful, but also requires a lot of effort," says Sobanski.

Enjoyable learning is most effective
For effective e-learning, it is not enough to ask existing specialists to pass on their knowledge. Rather, this information must be visually and audibly presented in an easily understandable and appealing form (learning from sense of duty is always less effective than enjoyable learning). Best practice e-learning should be interactive, easy and with individual modules of 20 to 40 minutes duration. For their creation, special software is required which is selected according to customer requirements. Templates are thus developed that provide a basic framework for the content and motivate learners in an appealing way. These templates also make it easier to quickly create additional training sessions without the need for special IT skills.
The time gained can be meaningfully used for the didactic processing of the content.

Therefore, e-learning can form the basis of a higher quality culture in the company, help to avoid mistakes in routine processes and also contribute to better identification by employees with their line of work. Within the company, the training topic will require more management attention and a financial foundation in the future.

About MAIN5 (www.main5.de)MAIN5 was established in 2013 as a Management Consulting firm and focuses on strategy, process and solution consulting with international life science companies in the regulated R&D and Regulatory Affairs and Quality Management sectors. The consultants at Main5 combine their methodical and systematic approach with years of experience in the industry. The holistic approach, which places the primary focus of the route to the digital future on people, is also used to implement complex ideas from leading industry customers.

Further information: MAIN5 GmbH & Co. KGaA, Administrative Headquarters: Schumannstr. 27, 60325 Frankfurt am Main, Germany Tel.: +49 (0) 69 505 027 228, email: presse@main5.de, Web: www.main5.de

PR Agency: euromarcom public relations GmbH, Tel.: 0611 / 973150, email: team@euromarcom.de

Big Data falls short - the consulting company MAIN5 presents study "Pharma Insights 2019"

Frankfurt, July 17, 2019 - Hardly any industry is dragged down so much by regulation in innovation work as the pharmaceutical industry. This was the key result of the "Pharma Insights 2019" study, which the consulting firm MAIN5 recently published. 65 percent of the processes in pharmaceutical companies are audit-focused, and the majority (70 percent) have grown organically over time. Only 8 percent of the processes are future-oriented, according to a survey of 94 specialists and executives from the pharmaceutical industry. "The pharmaceutical industry could tap much more potential, which often arises from necessity. As companies operate from audit to audit, the focus is progressively shifted away from competitiveness", says Tore Bergsteiner, Managing Director of MAIN5. Industry experts advise pharmaceutical companies on how to digitize regulated processes. So far, however, only part of the accumulated data from different business units are being analyzed and used for innovation and future optimization.

Big Data: Running at half power
64 percent of those surveyed assume that no more than half of data generated will be analyzed and future processes optimized. 26 percent of the interviewed professionals were reluctant to answer the Big Data question: "The uncertainty surrounding Big Data is huge. However, high-quality inventory data is the most valuable resource today when it comes to new innovations and process optimization", states Tore Bergsteiner of MAIN5. Still, the pharmaceutical industry is feeling the pressure, which is further confirmed by declining sales of blockbuster drugs: 47 percent of the study respondents state that the development of new growth markets and product diversification are just as important challenges. After that, respondents mentioned the protection of sensitive patient data with the fulfillment of GDPR (45 percent), and in third place, business risks due to expiring patent protection and thus generics in the market (44 percent - multiple answers were possible). Falling blockbuster sales also appear among the 2019 challenges at 41 percent.

Digitization: Hardly a risk
Respondents agree on the risk assessment of growing digitization in the patent- and knowledge-driven pharmaceutical industry: only 21 percent see a risk, but 70 percent agree this is exceedingly small or simply non-existent. "The depth of digitization will determine the distribution of market share in international competition and also with which active ingredients and drug combinations new products can be brought to the market," explains the MAIN5 Managing Director. With numerous mandates from the world's largest pharmaceutical companies, the MAIN5 team regularly reorganizes complete processes, structures and systems. The goal is to develop robust, efficiency-based process relationships and the sustainable, competitive positioning of a manufacturer or distributor in the global market of pharmaceutical companies.

The pharma industry is still facing increasing pressure. The age of blockbuster medication is over, while regulatory stipulations are becoming stricter. The annual conference of the DIA (Drug Information Association) is being held in Vienna from February 5 to February 7. The MAIN5 pharma expert panel (Stand B31) is focusing on processes and systems in research and development: "The market for pharmaceutical products is demanding faster development cycles at lower cost under increasingly strict international regulatory stipulations. As a result, the entire industry continues facing pressure to demonstrate productive and result-oriented work based on lower fixed costs," says Tore Bergsteiner, Partner of the consultancy firm MAIN5 which specializes in pharma companies.

Always aspiring for process excellence
Effectiveness, above all in research development, is increasingly under the microscope according to the team at MAIN5. "Value creation and a culture of performance in the R&D sector is being continually updated in a lot of businesses in order to guarantee that pharma companies are future-ready," says Tore Bergsteiner. However, successful research is not enough for overall success: By aspiring for "process excellence", and looking to optimize and modify existing structures, it is possible to create new impulses and energies that have not yet been utilized. "It's getting tight in the pharma industry thanks to digitalization and other innovations in healthcare. New job profiles are appearing, such as Data Scientists. Anyone who is not currently adapting their internal structures and ways of thinking will miss the exit before they know it," warns Dr. Adam Sobanski, Partner at MAIN5.

Therapy for people is the goal
The growth in regulatory requirements across all sectors is ensuring that intellectual riches are being represented in databases and documents. A focus on systems and processes for regulated data and document management in clinical development, approvals and more, is consistently contributing to compliance, efficiency and productivity. "In fact, an integrated data and document management system that will generate long-term value is already deciding the success or failure of new innovative developments in therapy. With solutions such as lab data management, clinical data management, and holistic document management, companies will enjoy significant benefits long-term," explains Bergsteiner.

New technologies on the road to success
There are plenty of opportunities for the pharma industry to make day-to-day business more efficient within the high-speed world of artificial intelligence development: The countless possibilities for digitalization range from more efficient lab work to the development and approval of effective therapies. Mental work automated using artificial intelligence is already speeding up and improving research, development and approval work. MAIN5 works as an adviser to leading technology providers with proven success.