| With submission structures adopting an increasingly large number of formats worldwide, Sarah Powell at Thomson Scientific recognises the pressing need for effective, global regulatory product management
Life science organisations are constantly challenged to bring new and improved products to market faster with fewer resources in an era where costly penalties are associated with failing to comply with regulatory requirements. As regulatory authorities standardise their submission structures through new and emerging formats, such as CTD, eCTD, EVMPD, SPL and PIM, the need for effective regulatory product management in the life science industry has become even more critical.
There is a plethora of information that must be managed and understood within a life science organisation. Regulatory professionals must understand: the regulatory landscape for the countries in which they manage products; the expectations of the regulatory authorities within that country; and how their product development and marketing strategies may be affected over time.
The required knowledge and understanding is vast, which makes it difficult to become a global expert in pharmaceutical development. Table 1 illustrates many of the reporting requirements for a product that may be involved in clinical research or marketing within the US, Europe and Japan. While this table is not all inclusive of the reporting requirements, it does highlight, even for this subset of requirements, the immense information that a regulatory professional must understand and track for their company’s products.
Table 1 (available in PDF file) illustrates reporting requirements only. Obviously there is more to compliance than ensuring you report appropriately. Information must continually be consumed, evaluated and applied. Steps 1-5 represent the process through which companies must understand their regulatory product information. These steps can be represented in a circular flow with overlapping segments, as this represents how information is continually gained and processed within an organisation. For example, a company developing a new product for the treatment of multiple sclerosis may ask the following types of questions within each segment. |
