Hans H. Linden, EUFEPS Senate, Leader European Projects, Stockholm, Sweden

People need medicines and they want them efficacious and safe. Safety concerns are, actually, all over in medicines research and development, and major reasons for discontinuing otherwise promising candidates. What is our system to deliver and collaborate within? How can it be done?

A system is (www.wikipedia.com) a set of interacting or interdependent components forming an integrated whole or a set of elements (often called ‘components’) and relationships which are different from relationships of the set or its elements to other elements or sets.

A system is (www.dictionary.com):
1. An assemblage or combination of things or parts forming a complex or unitary whole: a mountain system; a railroad system.
2. Any assemblage or set of correlated members: a system of currency; a system of shorthand characters.
3. An ordered and comprehensive assemblage of facts, principles, doctrines, or the like in a particular field of knowledge or thought: a system of philosophy.
4. A coordinated body of methods or a scheme or plan of procedure; organizational scheme: a system of government.
5. Any formulated, regular, or special method or plan of procedure: a system of marking, numbering, or measuring; a winning system at bridge.
A system is (www.businessdictionary.com):
1. A set of detailed methods, procedures and routines created to carry out a specific activity, perform a duty, or solve a problem.
2. An organized, purposeful structure that consists of interrelated and interdependent elements (components, entities, factors, members, parts etc.). These elements continually influence one another (directly or indirectly) to maintain their activity and the existence of the system, in order to achieve the goal of the system.
All systems have (a) inputs, outputs and feedback mechanisms, (b) maintain an internal steady-state (called homeostasis) despite a changing external environment, (c) display properties that are different than the whole (called emergent properties) but are not possessed by any of the individual elements, and (d) have boundaries that are usually defined by the system observer. Systems underlie every phenomenon and all are part of a larger system. Systems stop functioning when an element is removed or changed significantly. Together, they allow understanding and interpretation of the universe as a meta-system of interlinked wholes, and organize our thoughts about the world.
Although different types of systems (from a cell to the human body, soap bubbles to galaxies, ant colonies to nations) look very different on the surface, they have remarkable similarities. At the most basic level, systems are divided into two categories: (1) Closed systems: theoretical systems that do not interact with the environment and are not influenced by its surroundings. Only the components within the system are significant. Example: a sealed jar–nothing enters or exits the jar, but whatever is inside can interact. (2) Open systems: real-world systems whose boundaries allow exchanges of energy, material and information with the larger external environment or system in which they exist. Example: a company–even if there are separate departments in one organization, the workers share data and interact with each other on a daily basis. Different systems methodologies (such as systems dynamics and systems thinking) classify systems differently.
The “medicines system” will be sketched. Developing advanced master’s level education and training in safety sciences for medicines in collaboration, in the European Federation for Pharmaceutical Sciences (EUFEPS), in the New Safe Medicines Faster Project (NSMF), and in the Innovative Medicines Initiative (IMI) will be discussed. The mission of EUFEPS is, in short, to advance sciences for better medicines and health. In this it is contributing to science policy, medicines discovery, development, processing and usage – and to post-graduate education and training.

26Oct