Registration and Launch: The Next Steps of a Long Journey

Contributed by:

Robin Robinson

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

The registration and launch phase is evolving like the rest of drug development, and the industry must evolve its practices along with it. One big aha moment for the industry is to understand that data, study reports, and other regulatory documents are not the end, but rather integral parts of the journey. New regulations, new electronic submission requirements, and the increasing need for global submissions are keeping industry stakeholders on their toes. Registration: Challenges As of June 2009, FDA regulations require the electronic submission of drug registrations, listings, annual renewals, and updates of OTC drugs, active pharmaceutical ingredients, prescription drugs, homeopathic drugs… Sidebar: Transatlantic Regulatory ­Integration Experts on this topic Nancy Smerkanich, Executive VP, Global Regulatory Affairs, at Octagon Research Solutions Anne Tomalin, President of i3 CanReg Loni Jakub, Manager, ViewPoint Implementation Services, Octagon Research Ed Damp, Chief Operating Officer of BioPath Consulting Donna Michalizysen, Managing Partner, Precept Medical Communications Robin Winter-Sperry, M.D., President and CEO, Scientific Advantage and Science Oriented Solutions (SOS)

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