The first ever OIS Master Class commenced following this year’s OIS@AAO on October 14, 2016. The Master Class was, an invite-only, deep dive session on developing drugs and devices in ophthalmology. This half-day workshop gave 100 individuals an intimate setting to learn how to effectively move through the regulatory process from the experts themselves – FDA and CRO representatives. Please see below for the presentations featured at the class.
How Do Drugs Get Approved?
Wiley A. Chambers, MD, Deputy Director, Division of Transplant & Ophthalmology Products Center for Drug Evaluation & Research – FDA
Site Selection and Trial Execution in Ophthalmology – Pearls and Pitfalls
Darin Curtiss, PharmD, VP, Clinical Development – Trial Runners
How to Get Devices Approved?
Malvina B. Eydelman, MD, Director, Division of Ophthalmic & Ear, Nose & Throat Devices – FDA