The current operational environment in the pharmaceutical industry is the result of long-term trends: industry consolidation, globalization, and outsourcing.
Companies are growing in size due to acquisitions and mergers. Operations routinely span across geographical, jurisdictional and cultural boundaries. The trend of industry consolidation continues in 2015 and 2016: the total number of deals flattened and remained even at around 600 mergers a year. Geographically, mergers and acquisitions have been shifting from the U.S. to Western Europe. This shift is the result of transactions driven by the need to add complementary products to the core business areas, and tax inversions.
Pharmaceutical industry outsourcing in manufacturing, specialized services, clinical research, and even pharmacovigilance, has grown during the past 10 years and this trend is likely to continue. Outsourcing includes full range of corporate activities—from screening and lead identification, to toxicology and other pre-clinical studies, clinical trials, marketing, and manufacturing at all scales. The main outsourcing areas include product characterization testing, validation services, toxicity testing, analytical testing, and fill-finish operations. Much of the growth in outsourcing in the past decade has taken place in China and India.
The result of industry trends is increasing risk of disruptions due to reorganizations, complex vendor relationships, cultural and legal differences, single-source supply chain, high-impact accidents, natural disasters and other factors.
Pharmaceutical industry is global, complex, international, and highly regulated. Training is one of the most important ways, how to decrease internal vulnerabilities and improve organizational resilience.
To accommodate constantly changing needs, adapt to changing operational environment, and to achieve greater resiliency and agility, organizations need to be able to train their existing and newly coming workforce in much more systematic and flexible manner.
Regulatory environment in pharmaceuticals is constantly changing. Often conflicting national and international requirements and policies have to be translated into organizational SOPs and working instructions in a way that ensures unambiguous interpretation. This process requires coordinated inter-departmental effort to ensure consistency in implementation, to reduce liability stemming from non-compliance caused by lack of competency, need for improvisation, differences in interpretation, and human error.
Complexity of organization affects the number of entities involved in handling material and information, and increases the complexity of operations concerning its internal and external relations, roles and responsibilities and tasks assigned to functions, access rights management, and ultimately training requirements.
Globalization affects all functions of any enterprise from financial and legal to security situation in regions of interest. Increasing distance and time zone differences make the system slower to respond in case of disruptions. Training improves individual and collective ability to solve operational challenges aggravated by cultural diversity, differing communication styles, language barrier, and other factors in standard situations, as well as during crises.
Increasing complexity of operations is the result of changing nature of products traded. Consolidation of the industry increases complexity of organizations and their internal and external relationships, and limits sourcing options. Shift from blockbuster medicines to orphan medicines, individualized treatments and niche products increases the costs of operations. High volume products with predictable demand are managed differently and often follow different supply and distributions models than products with low and unpredictable demand.
Information management systems become more sophisticated and complex in response to these trends. New technologies, although valuable, create new vulnerabilities for the enterprise. Human ability to recognize and deter new threats is essential to counter social engineering efforts, hacking and data breaches.
After all, highly trained and qualified people are the most valuable assets of every learning organization.