Masterarbeit

From study protocol to final report -practical aspects and constructive input of the DRA/QA function in this process ***

Dr. Jürgen Hans Schmidt (2001)

In this thesis an overview has been given about the tasks of the DRA/QA function in the development process of a drug. Based on the example of a clinical trial the DRA/QA activities have been analysed. This analysis has demonstrated that development of company standards as well as the concrete implementation in the process starting from generating a specific study protocol up to a final study report needs continuos input from the DRA/QA function. Problem areas and frequent mistakes as well as measures for prophylaxis have been analysed. Based on three examples (UK, D, US) also regulatory pre-trial applications are described as well as the regulatory aspects of AE reporting and the in-process influence on the later intended labelling. Quality Control and Quality Assurance procedures for this process have been described and discussed.

Success factors are knowledge of the regulatory requirements, implementation of good systems and in particular good communication. The DRA/QA manager has to serve as centre of competence in the development network of the various functions. Practical experience in clinical development (skills) will improve DRA/QA acceptance in the development team. Staff with a combination of these backgrounds will improve the skill set of classical DRA departments. They have to be rewarded adequately in order to motivate them to move to the DRA function. The analysis set out in this thesis has made it obvious that the DRA/QA functions is very deeply involved in the whole process in order to arrive at a reliable study report which forms the basis for a successful regulatory submission.

The Common Technical Document process and the new EU GCP Directive will change the processes in the future. Details for implementation are currently unclear and will direct the respective discussions for the next two years.

In view of the need to establish a sufficient pool of regulatory intelligence and in order to assure a smooth and speedy drug registration process, the DRA/QA function will become even more important in the future for effective pharmaceutical companies

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