Tim Coté of Coté Orphan would like to invite you to Coté Orphan Boot Camp: La Jolla, CA.
Coté Orphan specializes in orphan regulatory affairs, risk evaluation, and streamlined project management. Coté's experienced team, led by FDA's former Director of the Office of Orphan Products Development (OOPD) Dr. Timothy Coté, guides clients through the entire orphan product development from conception to marketplace. Providing US and European orphan services makes Cotê the ideal global partner for the regulatory development and commercialization of orphan products. These unique services deliver efficient, customized solutions with unparalleled quality.
SPEAKER Timothy R. Cote, MD, MPH Coté Orphan - Principal & CEO Dr. Timothy R. Coté is a leading national regulatory expert in orphan drug development. With 22 years of Federal service at the FDA, NIH, and CDC, Dr. Coté most recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept 2007 – May 2011. Instrumental in implementing the Orphan Drug Act and personally signed over 800 orphan drug designations in his time at the Agency. From 2002 to 2004 he served as Branch Chief, Therapeutics and Blood Safety division in the CBER Office of Biostatistics and Epidemiology. In 2011 Dr. Coté also served as the Chief Medical Officer for the National Organization for Rare Disorders (NORD).
COTÉ CURRICULUM BY TIM COTÉ • Essentials of Orphan DRUG Designation • Pediatric/Tropical Rare Desiease Priority Review Vouchure (PRV) • Breakthrough Theropies for Orphans • Special Tenderness Offered to Orphans by the FDA Review Divisions
WHO SHOULD ATTEND Coté Orphan Boot Camp: San Diego will include key players (ie. executives, regulatory affairs associates and business development representatives) on the regulatory affairs industry will be educated first hand why orphan regulatory systems are fundamental to understanding of drug development regulatory law and science. This one-day seminar will provide you with everything you need to stay on the pulse of the biggest opportunities and trends impacting the current pharmaceutical landscape.