Regulatory regime: a burden or chance for knowledge?


Are pharmaceutical regulations a burden or an opportunity? What if the industry could turn detailed internal knowledge into new commercial power? James Hendry reports.


Les réglementations pharmaceutiques constituent-elles un fardeau ou une opportunité ? Et si l’industrie pouvait transformer des connaissances internes détaillées en nouvelle puissance commerciale ? Un reportage de James Hendry.


Sind pharmazeutische Rechtsvorschriften eine Belastung oder eine Chance? Was wäre, wenn es der Pharmaindustrie gelingen würde, detailliertes, internes Fachwissen in kommerzielle Macht zu verwandeln? James Hendry berichtet.


Above One company’s threat is another’s opportunity. Vision, stragety and organisation can reap rewards.


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he way regulatory information is managed and used in pharmaceutical organisations today is far from optimum, posing a business risk of losing valuable insights and missing out on commercial advantages, To turn this situation around, life sciences organisations need to take a more strategic approach to how they manage the critical regulatory


information that lies within their systems.


In just about every other aspect of business, the key to cost-justifying and maximising the return on an information-based initiative is transforming this into valuable business intelligence that can be acted upon to deliver tangible, broad-ranging benefits. Te same could be true of regulatory information, if only life sciences organisations were set up to recognise and exploit the opportunities.


Te reality, however, is that the wider purpose of and opportunities resulting from information recording and management are lost in the pursuit of a specific goal, such as regulatory compliance. Here, processes and systems are put in place and data accurately and securely recorded to meet agency requirements, for example by


supporting e-discovery. And while responding to the regulators is imperative, this need not be done at the expense of enhancing the interrogation of valuable data for commercial advantage.


Tere is no doubt that regulatory compliance - whether relating to product information management (PIM) requirements, pharmacovigilance, or meeting new health authority submissions standards (especially around eCTD) - poses a significant challenge to life sciences organisations today, Equally, though, companies must respond to intensifying competition, pursue new markets and support growing merger and acquisition activity, for example.


Knowledge is power Approached strategically, regulatory information management (IM) can help address all of these issues.


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