PTSM: Pharmaceutical Technology Sourcing and Management-07-09-2008

Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control.

A recent US government study shows that follow-on biologics are likely to have a favorable economic impact if proposed legislation authorizing a regulatory pathway in the US is approved.

Global manufacturing excellence will be a game changer for CMOs that can achieve it.