FDA-University of Maryland CERSI Cosponsored
Clinical Investigator Training Course
November 7, 2016, 7:30 a.m. - 5:15 p.m.November 8, 2016, 8:30 a.m. - 5:00 p.m.
November 9, 2016, 8:30 a.m. - 3 :30 p.m.
In this 7th annual Clinical Investigator Training Course clinical investigators will be trained by FDA medical officers and senior scientists--along with other experts--in all aspects of clinical studies: preclinical and clinical science, statistical structure of trials, ethical requirements, and regulatory considerations. In addition, the course will help foster communication between clinical investigators and FDA and enhance investigators' understanding of FDA’s role in experimental medicine.
See the Course Schedule for details on the 3-day course.
To register click the "Register" button at the top of the Registration page.
September 23, 2016
8:30 a.m. – 4:30 p.m.
Master protocols that run continuously and evaluate numerous investigational products simultaneously are being used to expedite clinical trial investigations for many medical products. This workshop will focus on pediatric master protocols. The workshop will provide a forum for discussion of the regulatory and scientific concerns of pediatric master protocols and clinical trial design considerations for these protocols. Additionally, applications of pediatric master protocols to specific therapeutic areas will be discussed.
Agenda, Remote Access, Registration
For all information see the Pediatric Master Protocols Workshop web page.