There are huge challenges happening to regulatory affairs, particularly with respect to outsourcing.  We are seeing a shift toward process optimization and off-shoring of the more operational tasks involved with regulatory operational work, especially for maintenance work for established products, including labeling, variations and renewals.  These changes are analogous to those seen in other drug development activities such as data management and biostatistics. This talk will focus on what these changes mean for regulatory professionals, and how those regulatory staff in the West can best position themselves to thrive in this new environment. Similarly, those in the East need to ensure that they obtain a thorough grounding in the profession in light of these titanic changes.

There are growing pressures on regulatory affairs groups due to increasing global requirements and other outside factors to do more with less. As a result, the current ways of working are not scalable and sustainable for the future. To meet these challenges, a transformative approach to regulatory work is needed - where technical expertise is coupled with end-to-end technology that streamlines workflow, embraces automations, and facilitates collaboration. These solutions will transform the delivery of regulatory services, improve efficiency and quality, while reducing cost and time for delivery.

The Town Hall Discussion includes an overview and a moderated audience discussion. The conversation will touch on the evolution of regulatory outsourcing including key topics such as:

• Growth/trends in the industry

• Strategy (service providers, models of outsourcing, functions and activities commonly outsourced, etc.)

• And key challenges (e.g., what to outsource vs keep in house?, how to ensure oversight/quality?, preparing for EU CTR, etc.)