Case Study: Implementing Foundational RIM in a Small and Medium Size Enterprise – Does Size Matter? The Alexion Experience

Vahe Ghahraman, Head, Global Regulatory Operations, Alexion

While implementation of RIM (and even the description of RIM) may differ widely from one enterprise to another, the foundational needs and the RIM framework may not be that different. There are of course, many factors that impact the scope, requirements, timing, and the intended utility, among others that need to be considered in the ultimate strategy and approach for implementing a RIM. During this presentation, Vahe will look at the specific case of Alexion’s RIM scope, process and strategy as a small to medium global bio-pharma company, and will attempt to draw parallels and contrasts with others.

MEET THE SPEAKER

Vahe Ghahraman

Vahé Ghahraman is the head of Global Regulatory Operations at Alexion. He has more than 17 years of industry experience with a focus on regulatory information management, global publishing, and submissions strategy and IT systems. Vahé has previously held various roles including consulting at Datafarm, Parexel, Millennium, Dyax, Takeda, and Dimension Therapeutics. He has extensive experience in establishing regulatory operations functions within growing bio-pharma enterprises. He has a Ph.D. in engineering from Northeastern University in Boston, MA.