What Are The Components Of A Regulatory Intelligence Function In Pharma?

It begins with defining the scope (e.g., GxP, quality), stakeholders, and communication channels. Understand the direction of the organization and its products, build the process, then refine and measure. The value of a dedicated in-house regulatory intelligence function should not be discounted. At its core, this function is responsible for ensuring awareness and preparation in response to changes in the global regulatory landscape, although the latter [preparation] may differ in maturity depending on the defined scope, resources, and expectations of the organization for this function. Regulatory intelligence is not just data mining. Minimally, this function should be responsible for impact assessments, stakeholder identification, prioritization, regulatory trending, follow-up, and evaluation. In some cases it can also be involved in regulatory strategy or even act as the conduit for comments and responses with health authorities.

JASON URBAN, PH.D.
Director of global quality risk management and compliance at Celgene.