February 2016

Table of Contents


Cover Story

Regulatory Requirements for Drug-Device Combinations: Are We Clear?

By Laura O’Brien, Ph.D., Boehringer Ingelheim Pharmaceuticals, Inc.; Nina Cauchon, Ph.D., R.A.C., Amgen Inc.; Willy Liou, M.S., R.A.C., Amgen Inc.; Tushar Mukherjee, Ph.D., Sandoz Inc.; and Satish Singh, Ph.D., Pfizer Inc.

With products ranging in scope and complexity, implementing even a streamline regulatory framework may be challenging.

Cover Story Sidebar

E.U. Regulatory Approach for Drug-Device Combination Products

By Stefan Leiner, Ph.D., and Christoph Kreher, Ph.D., Boehringer Ingelheim Pharma GmbH & Co. KG

Career Success

The World of Consulting--A Few Words of Advice

By Gary A. Thompson, Ph.D., FAAPS