Masterstudiengang "Drug Regulatory Affairs"

The European Product Information Management (PIM) project was launched by the European Medicines Agency (EMA) in 1999. Its goal was to establish a new and simpler way of handling/exchanging product information in the European Union and to ultimately improve the quality and consistency of product information.

Even though the PIM project, which in its complexity was certainly seen as a "sword of Damocles" by some pharmaceutical companies, has been halted in March 2011, one must be aware that structured product information is already reality: The Structured Product Labeling (SPL) project of the US Food and Drug Administration (FDA) went live in October 2005 and was continuously expanded since then.

One of the key features of structured product information certainly is the shift of paradigm associated with its implementation, the current document-based management of product information being replaced by a component-based authoring approach. Moving to structured product information will thus require considerable rethinking among the personnel/functions responsible for the generation of product information and major redesign of the related business processes in pharmaceutical companies.

The goal of this thesis was to provide an introduction into the area of structured product information from a global perspective. Both the health authority and the industry perspective are discussed. The latter with a focus on biotech companies, i.e. small to medium-sized enterprises based at a single location with a limited product portfolio, which are directly concerned by any EMA initiative in this field since biotechnology products fall within the mandatory scope of the centralised procedure. The ultimate target is to provide a basis for pharmaceutical companies for strategic decisions with regard to structured product information and the associated transition to a component-based mode of authoring product information.

Chapter 1 provides an introduction into the principles of component-based authoring. In the following, more technical, Chapter 2 the two health authority initiatives SPL and PIM are described using a comparative approach in order to highlight key differences of these systems. The impact of SPL and PIM on industry is discussed in Chapter 3. Chapter 4 investigates the question whether the transition to a component-based mode of authoring product information is associated with benefits in terms of process optimization independently of health authority requirements. It concludes with general cost-benefit considerations on different ways of implementing component-based authoring and defines basic criteria that may be helpful for decision analysis within pharmaceutical companies. Chapter 5, using the tools developed in Chapter 4, evaluates possible implementation designs in more depth from the specific perspective of biotech companies and analyses the impact of the PIM project being halted. Chapter 6, finally, provides an outlook and conclusions.

In summary, if one looks at structured product information and the concurrent transition to a component-based authoring mode from the industry side, there seems to be great potential for performance increase and process optimization. Various implementation designs with varying degrees of deployment ranging from free tools made available by health authorities to simple authoring tools or comprehensive labelling systems may be thought of and are worthwhile to be evaluated by all types of companies depending on their specific needs and business processes.

In Europe, however, with the PIM project being halted, the trigger to undertake the required decision analysis has faded and it is questionable whether the momentum infused into the area of structured product information management by EMAs statement of intent in September 2009 will be maintained.