Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Setting up a Regulatory Intelligence function - A thorough discussion on the process to initiate, develop, implement and maintain a trusted source of regulatory information

Sven Nisius (Abschlußjahr: 2015)

Summary
Language: English
As the products of the pharmaceutical industry have a large impact on the health of many people this industry is one of the most regulated industries globally in order to ensure that only benefit / risk – balanced products are made available to the market.
Accordingly, a tremendous number of regulations, guidances and stakeholder expectations have to be aware of and appropriately reflected in a development plan of a medicinal product. This is also evident for regulatory affairs matters and thus it is an integral responsibility of a regulatory professional to contribute the current and future regulatory requirements into the development plan discussions. As the development of medicinal products take years and the regulatory environment is changing continuously such contribution is not an one-time activity, it is a constantly required exercise to ensure that the development plan is always in-line with the current and especially future regulatory landscape.
Depending on each development candidate, but also depending on the company (e.g. its type, size, geographical reach and other parameters) the number and kind of regulations and also their sources are very diverse. With increasing publication of such regulations via the internet the process to gather all of the relevant information in order to subsequently enable appropriate reflection is becoming more and more essential. To support the individual regulatory professional the information gathering process and subsequently also the impact assessment of gained information can be performed by a dedicated subgroup of a regulatory affairs department. Such a subgroup can lead to efficiency savings as not each regulatory professional would need to familiarise with technical internet search features or can even replace manual searches. Moreover, such a subgroup could monitor the nowadays routine health authority communication platforms in the internet on behalf of the entire regulatory affairs department staff.
In addition, the responsibility for active monitoring for and steering of scientific commenting of new regulations and guidances can be placed in this subgroup most appropriately. Accordingly, this subgroup could inform the relevant company stakeholders and manage the commenting processing in order to ensure the best participation in the more and more standardised public consultation processes for new legislations.
Such activities of a dedicated subgroup are called “Regulatory Intelligence” whereas the definite range of activities can be diverse and specific for the individual company.
As shown in this master thesis, there are also different models to perform regulatory intelligence activities. Either each regulatory professional performs regulatory intelligence activities as part of the job, a company establishes a dedicated regulatory intelligence function which could perform a) all in-house or b) uses (additional) external support by a specific regulatory intelligence consultancy and/or proprietary databases or regulatory intelligence is performed by a mix of these models.
The decision analyses described in this master thesis for three different companies serving as examples for the variety of companies revealed that although the establishment of a dedicated regulatory intelligence function depends for each company on a variety and each time different parameters the value and meaningfulness is increasing and becoming evident the bigger and more complex a company. Accordingly, originator companies with a strong R&D approach across several therapeutic areas, ultimately acting on global level, are gaining the most benefit from the establishment of a dedicated regulatory intelligence function. Smaller and/or non-originator companies still benefit from dedicated regulatory intelligence functions but below an undefined threshold the regulatory intelligence activities become just a part of the responsibilities of a  regulatory professional.
Pages: 56