This scenario represents the misconception that having fewer products means a company needs a simpler RIM solution. However, as soon as you start marketing those products to multiple markets, you have a responsibility to meet those countries’ respective requirements to remain compliant.
Even smaller operations may have multiple, disparate systems and tools containing some of the data required to build submissions and maintain licences across a product’s lifecycle. If there are multiple data entries, who’s to say these are in sync?
All of this needs to be managed, just as with a larger organisation with considerably broader portfolios sold internationally.
Deploying RIM with Modest Resources
But of course there are situational differences too. Small to medium enterprises (SMEs) don’t share the budgets of bigger players; nor do they need projects of the same scope. Therefore, I argue for a phased approach to RIM implementation. One that starts with a solid foundation that helps address product lifecycle management – a minimum RIM specification that companies can build on over time, as needs demand it, and as resources allow.
Other considerations will be how information and processes should be governed – whether this is best centralized, or whether a more distributed set-up can work - and the associated considerations for quality control, and compliance, among others.
Assuming that a basic, foundational RIM approach is the way forward, I propose spanning registration tracking and management, the plotting and coordination of timelines, and change management - with a country-by-country view.
The point is that, whatever the company’s size, the days of managing regulatory information and associated processes using a patchwork of SharePoint and Excel spreadsheets belong to the past. As global regulatory requirements expand, and are adapted with increasing frequency, a firms’ RIM capabilities must stay in step. Complying with the upcoming IDMP in EU is a concrete example of such requirement.
To learn more about the Alexion story, watch the webinar "Case Study: Implementing Foundational RIM in a Small and Medium Size Enterprise – Does Size Matter? The Alexion Experience," available on demand. Watch Now!
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Vahé Ghahraman, PhD, is Senior Director of Global Regulatory Operations at Alexion Pharmaceuticals in the US. He has over 17 years of global regulatory operations, project management and regulatory technology experience, with a special focus on regulatory information management, publishing and global submissions strategy. Vahé has had various roles at Takeda, Dyax, Millennium, Parexel and Datafarm, and has also been involved in consulting activities. He currently heads the Global Regulatory Operation at Alexion, a global biopharmaceutical company which specialises in developing and delivering life-transforming therapies for patients with severe and life-threatening rare disorders. Its global headquarters are in New Haven, Connecticut, soon moving to Boston, Massachusetts.
Elvis Paćelat 1min read 05/04/19