During my career at Schering AGI successfully built up and led a department at the interface between Regulatory Affairs and Product Supply managing 16 000 variations per year at an international level. The department worked according to the principles of total quality management thus being highly efficient and fit for GMP inspection.
The regulatory database, which I had designed, implemented on a worldwide level, was fully validated in accordance with CFR, Part 11. The regulatory data entered into this IT system formed the regulatory basis for the release of products within Product Supply and automatically generated the regulatory data for all Product Quality Reviews.
Quality Assurance (QA) of an international pharmaceutical company had listed “Regulatory Affairs” in their internal audit program – at that time they were experiencing numerous diffuse problems within this expert function. Regulatory Affairs is not subject to GxP regulations, there are no defined rules available which may be used as reference during an audit. The findings were to be laid out to improve the processes but the audit result was not to have a negative political impact on the audited function. This was the background to me being engaged by QA to audit the company’s expert function “Regulatory Affairs”.
In order to determine the direction and feasibility of the audit, I began by looking into the mind-set of the company’s internal environment. When analyzing the apparent problems, I recognized a high risk for the company’s regulatory compliance.
Based on these insights I prepared an inspection plan where I defined goal, scope and evaluation criteria for the potential findings and aligned them with the customer. The topics comprised organization and management, data-capturing and data-maintenance, external and internal regulatory processes. Subsequently I prepared dedicated catalogues of questions on which I based my individual audit interviews.
When planning and conducting the audit two problems appeared: Regulatory Affairs is an interface-marked function which highlights deficiencies deriving from the interface functions. It is necessary to list these deficiencies but one needs to take care not to look for the root cause only within the audited department. Secondly the deficiencies and findings have to be listed in detail in order to define concrete measures, while at the same time the audited department was not to be given a politically negative appearance. I solved the conflict and gained the trust of the audited department.
By this I enabled trust-based interviews and protected the audited Regulatory Affairs from negative political impact.
Now the company has at its disposal unbiased well-defined findings which are accepted to be meaningful and forward-striving both by the audited expert function as well as the QA. The measures resulting from these can be followed up by using established QA-tools (CAPA-management) in order to overcome the detected problems efficiently.
The success of the audit was mainly attributed to my many years of experience in regulatory operating principles and processes. My integrity within the political balancing act and my stringent and consistent approach resulted in future-striving measures with lasting effect.
A German pharmaceutical company realized that the quality part of their marketing authorization submissions did not meet the current requirements – the worldwide roll-out of old products (application for authorization in new countries) would not be possible without jeopardizing the existing approvals.
After analyzing the company’s workflow for preparing and maintaining the marketing authorization documentation I recognized that only fundamental company-wide changes to the process would lead to a sustainable improvement of the compliance situation. Senior management decided to follow my advice and assigned me the task of developing and implementing a new concept.
In cooperation with the expert functions Regulatory Affairs, Production and Quality Control I began working out the new strategy for the preparation of the quality part of the dossier. This concept enables the company to maintain the marketing authorization documentation throughout the product’s life-cycle and clearly lays responsibility in the area of the expert functions. Next I developed form and content of templates, standardized the preparation of marketing authorization documentation, established data management and wrote dedicated SOPs (standard operation procedures) to guide and control this process. Based on this I trained the expert functions throughout the revision of the marketing authorization dossiers documentation, prepared the Health Authorities for the envisaged submissions and closely linked the company’s internal quality management with regulatory activities.
Now the company maintains a fully functioning routine process for the preparation and maintenance of marketing authorization dossiers which leads the field and is the envy of competitors. It has meanwhile up-dated one quarter of its portfolio. The company’s compliance situation has thereby completely changed for the better.
The success in implementing the compliance-generating and -maintaining process was mainly attributed to my many years of experience in practical implementation with existing resources and my knowledge regarding the political discrepancies between expert functions.
A pharma company was in the process of reorganization in preparation for worldwide expansion. Within the scope of diversification from “one-does-all” to process-regulated workflows, corporate management realized that regulatory activities required new positioning and structuring to get the company fit for future, and mandated me to reorganize the expert function.
After a brief analysis of the existing procedures and practices I started to form the regulatory affairs staff into an effective unit. Together with the personnel I developed comprehensive transparent workflows and defined clear roles. I organized, implemented, and trained the staff to use an information system which allowed the individual members of staff to accomplish their own tasks and also to maintain an overview of the activities of their colleagues without interfering. I used the company’s internal IT-tools, documented the workflows in the company’s SOPs (standard operation procedures) and implemented the processes by training the staff on the job and tracking their activities.
As a result, the company could successfully meet the challenge of the upcoming expansion and globalization. My work has led to a pronounced and sustainable increase in the efficiency and reputation of the regulatory affairs function of this company.
The success of the restructuring was mainly attributed to my many years of experience in developing well-functioning workflows in the regulatory field which not only increased efficiency but were effort-saving for the individuals and were therefore met with great approval.
A global pharmaceutical company (marketing authorization holder) faced the problem that their regulatory paper archive and data management no longer met the current requirements. The maintenance of compliance with current personnel coverage was put at risk – it was necessary to act immediately.
What stood against a radical renewal (e.g. buy and implement an out-of-the-box piece of software) was that neither enough personnel, know-how nor budget were available, and traditional paperwork was to be maintained. The customer asked me to take over the project management, the development and the implementation of new tools and workflows.
After a brief analysis of the existing archiving system, the workflows for document dispatch and data management within the regulatory expert function, I developed and presented a comprehensive concept. This was followed by discussions and consultation with the customer. Then I began to gradually implement the plan using a great deal of diplomatic sensitivity:
First I specified an electronic archive which met precisely the needs and the budget of the expert function. I guided and managed the IT-vendor who had previously been selected by the customer; I tested, implemented and validated the software and in this way kept the expert function nearly unaffected. Together with the staff of the expert function I developed the strategy for the initial filling of the system and supported them with training, advice and tracking. I incorporated the process of electronic and paper archiving into the available workflows such that continuous maintenance was assured, and in addition I wrote and gave training on SOPs (standard operation procedures). Today this archive houses all dossiers which are ready for submission or have been submitted and thereby reduces the search for documents to a minimum.
Next I specified the regulatory database, which I tailored exactly to the scientific and technical needs of the company and the communication with the archive. Also in this case, I guided and managed the IT-vendor during the technical development and tested, implemented and validated the software with my own staff. Together with the staff of the expert function I developed the strategy for the initial filling of the system as well as the workflow for the forthcoming continuous capturing of regulatory data. I brought the workflows to an agreement with the interfacing departments and wrote and gave training on the respective SOPs.
Additionally, I supported the company with data management: both at a theoretical level with regard to interpretation of regulatory data and the maintenance of the respective conventions and at a practical level where my staff researched, checked and interpreted the company’s world-wide distributed regulatory data and entered them in a standardized form into the database.
Today the company has at its disposal a regulatory database, which depicts the current regulatory status and the submitted dossiers of all products in all countries at the click of a button thereby forming the basis for compliance required by GMP. The adapted workflows are supported by SOPs and are fully implemented in the expert function. The search for data has been reduced to a minimum, data and expert function may be audited and the regulatory data is transparent and available throughout the company.
The success of the project was mainly attributed to my continuous, stringent and politically sensitive support ensuring that focus on the central thread was maintained. The personnel of the company were sufficiently involved without letting precious in-house capacity trickle away into the project. The innovations which were established on the way were always seen as work-simplifications.
A research-based pharmaceutical company recognized that the research and development of new products was being processed insufficiently. Neither the “pipeline” with new developments nor the time down to regulatory approval were controllable, and the resulting marketing authorizations were an inadequate reflection of the market requirements.
Together with personnel from Research and Development and Regulatory Affairs I developed workflows and roles for the staff, defined standard milestones and developed systems for tracking. In my consulting I placed great emphasis on the feasibility of the workflows and tools and their acceptance by the staff. I succeeded because I incorporated the company-specific operating principles, the available staffing level and the developmental peculiarities of the products, and integrated available workflows and systems whenever possible. I documented the result in the R&D handbook which describes the process of “How to get from the idea to the product”. The handbook comprises the description of roles, committees and bodies, routes for decision-making, tools for tracking as well as templates to describe the status of development projects in a standardized way. To support implementation, I prepared presentations for management and staff as well as a sophisticated training concept which was rolled out over the entire company.
The company has meanwhile gradually been trained and implemented the R&D handbook with my support. The “pipeline” for new development products is henceforth transparent and controllable; the time-to-approval has been reduced considerably. Products are now developed by “design” and no longer by “chance”.
The success of the project was mainly attributed to my high level of practical experience with regard to complex workflows, my precise valuation of what is feasible within a politically critical environment and my stringent and sensitive accompaniment of the staff i.e. in the “train-the-trainer-process”.
I am a frequent conference speaker in Germany and elsewhere. My specialist topic is, naturally, regulatory compliance and my presentations are highly praised. Comments have included: “she is a highly sympathetic speaker”, “she is always practice-oriented” and “she makes a good connection between theory and practice”.
My in-house seminars involve the customers and are directly tailored to their needs. They have received comments including: “We are no longer left out in the rain”, “we received more than we hoped”, “this was a great help to help ourselves”.