Of the 18 new drug and biologics molecules approved in 2010, about half seemed to have been developed by small companies. The Center for Drug Evaluation and Research (CDER) just announced an upcoming forum on designing clinical trials. This session is specifically for small businesses who want to learn more about how to plan and execute trials so they will generate data that meets FDA‘s review standards.
According to CDER, topics to be covered include:
– Clinical trial design – the phased approach and the staged approach
– FDA’s Bioresearch Monitoring (BIMO) Inspection Program
– Challenges to conducting clinical research in the 21st century
– Practical concerns of electronic source documentation
– Different types of pharmacokinetic studies conducted during drug development
– Importance of bioequivalence studies
– Strategic Quality for Clinical Trials
– FDA inspection process
There is no fee to register for this meeting, and there are limited seats available.
Register, and download the agenda and presentation slides here.