Success stories

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 the 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 Mónica 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 her advice and assigned her with the task of developing and implementing a new concept.

In cooperation with the expert functions Regulatory Affairs, Production and Quality Control Mónica 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 she 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 she trained the expert functions throughout the revision of the marketing authorization dossiers documentation, prepared the Health Authorities for the envisaged submissions and closely linked company 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 Mónica’s many years of experience in practical implementation with existing resources and her knowledge regarding the political discrepancies between expert functions.

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A pharma company was in the process of reorganization to prepare itself 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 Dr. Mónica Unger-Bady to reorganize the expert function.

After a brief analysis of the existing procedures and practices Mónica started to form the staff of regulatory affairs into an effective unit. Together with the personnel she developed comprehensive transparent workflows and defined clear roles. She 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. She 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. Her work has led to a pronounced and sustainable increase in the efficacy and reputation of the regulatory affairs function of this company.

The success of the restructuring was mainly attributed to Mónica’s 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.

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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 Dr. Mónica Unger-Bady 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, Mónica developed and presented a comprehensive concept. This was followed by discussions and consultation with the customer. Then she began to gradually implement the plan using a great deal of diplomatic sensitivity:

First she specified an electronic archive which met precisely the needs and the budget of the expert function. She guided and managed the IT-vendor who had previously been selected by the customer; she tested, implemented and validated the software and in this way kept the expert function nearly unaffected. Together with the staff of the expert function she developed the strategy for the initial filling of the system and supported them with training, advice and tracking. She incorporated the process of electronic and paper archiving into the available workflows such that continuous maintenance was assured, and in addition she 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 she specified the regulatory database, which she tailored exactly to the scientific and technical needs of the company and the communication with the archive. Also in this case, she guided and managed the IT-vendor during the technical development and tested, implemented and validated the software with her own staff. Together with the staff of the expert function she developed the strategy for the initial filling of the system as well as the workflow for the forthcoming continuous capturing of regulatory data. She brought the workflows to an agreement with the interfacing departments and wrote and gave training on the respective SOPs.

Currently she supports 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 her staff researches, checks and interprets the company’s world-wide distributed regulatory data and enters it 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 continuous, stringent and politically sensitive support of Mónica who ensured 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.

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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, Development and Regulatory Affairs Dr. Mónica Unger-Bady developed workflows and roles for the staff, defined standard milestones and developed systems for tracking. In her consulting she placed great emphasis on the feasibility of the workflows and tools and their acceptance by the staff. She succeeded because she 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. She 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 she 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 Mónica’s 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 Mónica’s high level of practical experience with regard to complex workflows, her precise valuation of what is feasible within a politically critical environment and her stringent and sensitive accompaniment of the staff i.e. in the “train-the-trainer-process”.

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Mónica is a frequent conference speaker in Germany and elsewhere. Her specialist topic is, naturally, regulatory compliance and her 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”.

Her 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”.

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