Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Introduction of electronic systems supporting the submission management of the Regulatory Affairs department in a medium-sized pharmaceutical company, with special focus on the implementation of the ICH eCTD standard

Dr. Thomas Stoiber (Abschlußjahr: 2005)

The introduction of the ICH eCTD standard for electronic submissions in 2003 can be regarded as a substantial challenge for the regulatory affairs departments of the pharmaceutical industry, regardless of company size. A consequence of the implementation of electronic review processes at authorities will be the need to submit high-quality dossiers in electronic as well as at least for the next in years in Europe paper form. Practical experience has shown that this normally requires the installation of specialised commercial programmes like submission management systems offered by a handful of software suppliers.

In this Master Thesis, a project for the selection and implementation of such a system at a medium-sized company is described. The initial step consists of the design of a project plan based on the definition of workflow processes during electronic dossier compilation and further technical and user-related requirements, together with a consideration of financial aspects. For the evaluation of commercial software solutions, selection criteria are developed by direct comparison of the current offers on the German market. A strategy for negotiations about a customer-specific license contract with vendors of favourite software solutions is suggested, and the reasons for the final decision for a well proven and widespread submission management system are made comprehensible.

A main focus of this project report is directed towards the subsequent implementation phase at the company. At the beginning, a system configuration for the customization of document management functions is performed. The software installation phase conducted by an IT administrator is described from the viewpoint of the regulatory department. Then the three basic steps of system validation are explained, combined with a look at more sophisticated requirements of software quality assurance as demanded e.g. by the FDA. The project reports ends with the basic training of future users, a step essential for a smooth transition into regular employment of the submission management system at the
regulatory department.

Through the entire project report, special focus is concentrated on aspects especially important from the view of a mid-sized generic company mainly orientated towards the European markets. Besides software facilitating submission management, an overview about other helpful electronic tools for regulatory departments is presented, accompanied by a report about testing a programme designed for the comparison of labelling texts.
The performance during the software introduction project is critically evaluated employing so-called Operational Management Tools like Decision Analysis and Potential Problem Analysis. Based on these results, recommendations for similar approaches at other companies can be made.

Finally, the concept of this Master Thesis goes beyond a simple description and analysis of a software implementation project. During introduction as well as conclusion and outlook, an attempt is made to give the reader an idea of the development of electronic submissions within the ICH regions, beginning with first pilot implementations 20 years ago, followed by a closer look on the current situation especially with respect to the acceptance of the eCTD standard, and finishing with prospects for future requirements. Throughout the work, existing differences concerning the approaches of European agencies on one hand and the FDA on the other are analysed. An emphasis is put on the fact that pros and cons of working (exclusively) with electronic submissions should not only be seen from the mostly economic viewpoint of the industry, but also with respect to the needs of assessors at authorities.

Pages: 56