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Final Week for Early Bird — Regulatory Paths for Expedited Drug Development Conference

Over the last two decades, there have been concerted efforts to increase harmonization across these regulatory bodies and eliminate unnecessary barriers that may delay or otherwise impede the efficient development and production of pharmaceuticals. However, relatively less attention has been paid to harmonization across the expedited pathways.

The Innovative Regulatory Pathways Summit, taking place January 29–30, 2018 in Arlington, VA, is the premier regulatory affairs conference dedicated to global strategies for expediting drug development.

Andrew StoreyVice President, Global Regulatory Strategy at ABBVIE, will discuss AbbVie’s experience acquiring multiple breakthrough therapy designations and how to utilize increased communication with the FDA to effectively expedite drug development.John BillingtonDirector, U.S. Public Policy, Vaccines at GLAXOSMITHKLINE, will present a public policy perspective on regulatory policies and market-shaping considerations for emerging infectious diseases and how they are influenced by current regulatory policies.

Mark Stewart, Ph.D.Senior Science Policy Analyst at FRIENDS OF CANCER RESEARCH, will explain the role of patient-focused drug development to build a clinical trial framework for breakthrough therapies.

Alejandro D. Ricart, M.D.Executive Medical Director, Oncology, Early Development Strategy and Innovation at NOVARTIS, will share breakthrough therapy designations in oncology with a focus on the importance of pivotal study vs. confirmatory study for BTD.

Our interactive sessions dedicated to global options for expedited drug development with feature thought leaders from across the biomedical landscape. Download the brochure to learn about these speakers and the strategies for expediting drug development that we will discuss in January.

There is only one week left to take advantage of our Early Bird rate! Reserve your seat today to save $200 off your registration.

posted in ExL Events News

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