American Association for The study of Liver Diseases - Food and Drug Association (AASLD/FDA) Conference on Trial Design and Endpoints for Clinical Trial in Adults and Children with Primary Sclerosing Cholangitis
In-Person EventMar 03 - 04, 2016Silver Spring, Maryland, USA
AASLD/FDA Conference on Trial Design and Endpoints for Clinical Trial in Adults and Children with Primary Sclerosing Cholangitis is organized by American Association for The study of Liver Diseases (AASLD) and Food and Drug Association (FDA) would be held during Mar 3 - 4, 2016 at US Food and Drug Administration, Silver spring, Maryland, United States Of America. The targeted audience for this medical event basically for Pediatrics.
The goal of this workshop is to promote successful and meaningful clinical trials and drug development in Primary Sclerosing Cholangitis (PSC) by identifying and clarifying what is currently known to determine the best trial designs, populations and endpoints.
The Objectives of this CME conference are :
1.Clearly define diagnostic criteria for PSC and different subtypes and stages of both adult and pediatric PSC.
2. Identify potential endpoints for each subpopulation that may be useful in different stages of drug development, for both adult and pediatric populations.
- Early phase – proof-of-concept and dose-ranging trials
- Clinical benefit endpoints for trials for marketing approval
- Surrogate endpoints for use in accelerated approval trials
NOTE - Due to space limitations for this course, only two attendees per company from the pharmaceutical and medical device industries will be permitted to attend.