Christian Schmitz-Moormann, a senior consultant and pharmacovigilance (PV) expert, and partner of Generis, considers the role of this essential master resource in maximising opportunities to improve R&D processes and wider product lifecycle management.
Large pharmaceutical companies are often restricted by a lack of ability to exchange information and access data from other departments. Prompted by regulatory changes, they have largely transformed marketing authorisation (eCTD) submissions and pharmacovigilance (PV) reporting, so now the attention is turning to the management of the Pharmacovigilance System Master File (PSMF). That’s because of its bearing on so many other aspects of research and development, wider product lifecycle management, and associated information management and reporting.
The PSMF is a core document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorised medicinal products. Bringing its management and data exchange capabilities up to scratch digitally makes sense now, given that its contents are so comprehensive and wide-reaching.
A Vital Master Resource
The PSMF’s numerous sections and appendix require information and input from areas across the Quality, Safety, and Regulatory domains. Despite this, many organisations still use manual processes and tools such as Microsoft Word or Excel to maintain and track the master file. As well as exposing companies to non-compliance, inefficiency and delays, a manually-maintained PSMF limits visibility and transparency: characteristics which, if addressed, could be invaluable right across the business.
Part of the challenge around PSMF management is that so many different people are involved in providing contributory information. The file needs to be handy at all times, too – in a single, definitive location, and suppliable to an authority in the defined structure (also printable, or in an acceptable electronic format) within one week of a request being made, in the EU at least.
Although companies do have the option to lean on an external service provider to maintain and update the PSMF, the price tag for this can be hefty – running into the low six-digit range in the case of a very large pharma organisation with a great number of products, for each fresh version that is needed (not including the annual maintenance cost).
The alternative approach is to ‘divide and conquer’, allowing approved, live information to be pulled from individual, relevant departmental systems, and extracted and put together to form a comprehensive and accurate PSMF. This can be achieved by integrating a PSMF management capability with existing functional systems across the pharma organisation, or by implementing a single open platform where all of the master information resides, already supporting any necessary integration and formatting standards.