CHAIR
:
Mark W. Browning, Esq, JD (SCHAGY), Consumer Safety Officer, OMPQ, Office of Compliance, CDER, FDA, United States
SPEAKER
(S):
Karen E. D'Orazio, (SPKAGY), Pre-Approval Manager, Office of Regulatory Affairs, FDA, United States
Hitesh A. Patel, (SPKNON), Product Manager, Pharma Technical Regulatory, Hoffmann-La Roche Inc., United States
Mark W Browning, Esq, JD (SPKAGY), Consumer Safety Officer, OMPQ, Office of Compliance, CDER, FDA, United States
Description
This session will discuss the phase 1 pilot for development of an automated form used to submit data from the manufacturer to the Office of Regulatory Affairs and Office of Manufacturing and Product Quality.