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Guiding principles

Guiding Principles (Source: PEI)

A definition of goals is a prerequisite for the implementation of a quality assurance system and an output-oriented accounting system. We started with defining guiding principles for the Paul-Ehrlich-Institut which describe how we set out to fulfil our tasks. Some of these principles describe the actual situation, others describe the goals we aim to achieve. These are the seven principles which will in future govern our work:

We use our knowledge and expertise to ensure the safety, efficacy and quality of biological medicinal products as well as for ensuring their availability and new developments

The Paul-Ehrlich-Institut has been playing a major role in controlling the safety and efficacy of biological drugs since they were first used in therapy and prophylaxis more than hundred years ago, when it operated under a different name with the Nobel prize winner Paul Ehrlich as its head. Since then a wealth of experience has been accumulated about the successes and the risks of using biological drugs, which is rarely equalled world-wide. It is this basis which enables us, the staff members of the Paul-Ehrlich-Institut, to fulfil our most important task: using our knowledge and expertise in the field of biological drugs to serve the health of humans and animals. The granting of marketing authorisations and the release of batches are the most important but not the only tasks with which we have been entrusted by statutory provisions. For example, we do research work and also act in an advisory capacity in the development of innovative drugs.

We co-operate at the national, European and global level

A mandate in the service of health is global, since health hazards do not stop at national boundaries. Fulfilling this mandate is made easier by European harmonisation and the globalisation of many other international relationships. This is why we bring our knowledge and expertise to bear not only nationally but also in Europe and globally. We actively co-operate in the development of international standards with the objective of increasing the safety of drugs.

High-level experimental research is the indispensable basis for our competence

Outstanding and scientifically grounded expertise in all our fields of activity is an essential prerequisite for the quality and acceptance of our decisions and recommendations. We achieve this expertise by virtue of experimental research that is able to compete internationally. Our fields of research cover a wide area ranging from license-related issues to investigations of fundamental bio-medicinal phenomena. The development of experimental methods as an alternative to experiments with animals is of particular importance.

Our work is characterised by its high level of quality combined with short processing times and cost-effectiveness

Only a consistently high quality of our work can ensure a successful commitment to the safety and efficacy of biological drugs. In this respect, the legitimate interests of the pharmaceutical manufacturers and the ever scarcer availability of resources also have to be taken into consideration. Therefore, the demands on the quality of our work are combined with a result-oriented approach and cost-effectiveness.

We are prepared for international competition

The European provisions on the circulation of drugs have opened up new possibilities for the manufacturers of pharmaceuticals. Whereas they used to have to apply to the competent authority of their own country, in many fields they now have the option of selecting a competent authority in any of the EU member states for a Europe-wide centralised procedure. This is creating competition among the authorities of the European Union member states, a challenge which is being successfully met by the staff members of the Paul-Ehrlich-Institut. Over the next few years, we should like to be chosen even more often by the pharmaceutical manufacturers as their competent partner.

Initiative, commitment and teamwork are instrumental in achieving our objectives

The challenge we have taken up is complex and can scarcely be mastered by individuals alone. Our objective can be achieved only by jointly agreed action combined with specialist knowledge. This also means that the skills of staff members should be fostered by means of advanced training, etc. and that they should be encouraged in their readiness to assume responsibility. Everyone should have the same opportunities to develop their abilities to the full. Not only the purpose and objective of our work, but also the way in which it is implemented, encourage us to perform our tasks with special commitment.

Our work is characterised by impartiality and confidentiality, wherever necessary, and transparency, wherever possible

In realising our tasks and objectives we maintain the highest degree of honesty, impartiality and, as far as necessary, confidentiality vis-à-vis vaccinated persons, patients, users and manufacturers. We are enhancing the transparency of our work so that the general public, the members of the medicinal professions and the pharmaceutical industry are better informed.

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