Regulatory workload rises for drug firms
A growing volume of global drug development and commercialization activity has dramatically increased the workload for regulatory affairs professionals at pharmaceutical and biotech companies, the Tufts Center for the Study of Drug Development said in a new study.
The study found that the regulatory affairs function within drug development companies has grown steadily, with most departments tending to hire from within, Tufts Center said in a press release. "This comes at a time when a growing number of those companies are outsourcing more of their clinical trial work to external service providers."
Ken Getz, the Tufts Center senior research fellow who conducted the study, said in a statement: "As more of the clinical function continues to be outsourced, regulatory affairs personnel will need to coordinate closely and communicate with external service providers. They will be challenged to handle a growing workload as their companies seek to improve R&D efficiency in an operating environment marked by ever-rising costs."
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