Tag: Lisa Pitt

Clinical Research: Phase 1 - Phase 4

Medical Device Regulation: Finding Your Path to Success

Successfully navigating the medical device regulatory landscape requires a well-defined and understood approach and knowledge of best practices specific to the device field. While device and drug development follow the same basic steps, there are key differences in regulations, approval pathways, and clinical investigations required for medical devices in the United States and European Union....

Clinical Research: Phase 1 - Phase 4

Informed Strategy Key to Drug Development Innovation, Premier Research Says in Naming Regulatory Chief

DURHAM, N.C., June 27, 2016 — Small biotechnology companies taking new biopharmaceutical products from benchtop to bedside need an informed regulatory strategy and a close working knowledge of the Food and Drug Administration and other regulatory agencies. So when it sought a new head of regulatory affairs, clinical development service provider Premier Research found its ideal...

Medical and Regulatory Affairs

What’s Ahead in Orphan Drugs? Attend Our June 1 Webinar

DURHAM, N.C., May 31, 2016 — Treatment of rare indications is turning a promising corner as regulators and lawmakers boost incentives and guidance in these areas of unmet medical need. Three experts from Premier Research will look at financial aid, expedited reviews, and other avenues available to orphan drug developers in a webinar on Wednesday, June...

Medical and Regulatory Affairs

Premier Research Names Lisa Pitt VP of Global Regulatory Affairs

DURHAM, N.C., March 15, 2016 — Premier Research announces the appointment of Lisa Pitt as Vice President of Global Regulatory Affairs. Joining Premier Research from the U.S. Food and Drug Administration, where she was a senior regulatory project manager, Dr. Pitt provides strategic guidance and oversees the company’s regulatory affairs service offerings in rare diseases...