Speakers

Jayani Perera is a senior chemist in the Office of Product Quality Assessment III (OPQAIII) in the Office of Pharmaceutical Quality (OPQ) in the FDA’s Center for Drug Evaluation and Research. She has assisted in the design, optimization, and management of the GDUFA Completeness Assessment process and the Timely Consult and Early Information Request (TCIR) Process for Drug Master Files. Jayani has also served in the GDUFA III DMF implementation working group and assisted in drafting the Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA draft guidance. Jayani holds a Ph.D. degree in Inorganic/Organometallic Chemistry from Wayne State University in Detroit, Michigan.