Donate Now Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

DIA Global Center

Sep 11, 2017 8:15 AM - Sep 12, 2017 3:30 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

Back to Agenda

Welcome, Introduction, and Session 1: Introduction/Overview of FDA

Session Chair(s)

Albert S. Yehaskel, MBA

Albert S. Yehaskel, MBA

President and CEO

Refuah Global Pharmaceutical Development, Inc., United States

FDA’s mission and how FDA is organized
CDER/CBER/CDRH role and responsibility
Critical role of FDA reviewer
Role of FDA chemistry reviewer
Responsibility of sponsor
What is CM&C
FDAs concerns with CM&C
Laws, regulations, policies and procedures

Have an account?