Upon completion of this activity, learners will be able to:
Define key terms as they apply to expanded access.
Identify expanded access measures.
Identify the elements of an expanded access application.
Recognize different types of expanded access.
Outline the primary responsibilities of sponsors and investigators.
References
Food & Drug Administration (FDA)
Reagan-Udall Foundation
ADVARRA
Speaker(s): Melisa Clark, MS, CCRP
Speaker(s) Bio
Melisa Clark is the Senior Regulatory Manager at WEP Clinical. She graduated from the University of Central Arkansas with a Bachelors of Art in French, and received a Masters of Applied Science from Lyon 2 University Berges du Rhone in Lyon, France. Melisa has more than 8 years of clinical research experience in many different areas such as: Expanded Access, FDA Regulator Affairs, Drugs/Biologics/Medical Devices, and IND//IDE Submission and Management, to name a few.
