SPEAKER WILL BE PRESENTING REMOTELY - Made possible with the support of Invio, Inc.
TOPIC: Review Draft Guidance for Industry: Medical Product Communications That Are Consistent With the FDA-Required Labeling
TOPIC DESCRIPTION: Review of the Guidance for communications that present information about a product that is not contained in the FDA required labeling.
SPEAKER: Joyce Chiarenza - SPEAKER WILL BE PRESENTING REMOTELY - Made possible with the support of Invio, Inc.
SPEAKER BIOGRAPHY: Joyce has over 45 years in the pharmaceutical and biotech industries (16 years at Genentech, Inc.) with diverse experience and responsibilities in Regulatory Affairs, Compliance, Clinical Compliance, Quality Assurance, and Quality Control. She is a certified Clinical Compliance Professional and has served on the grant review committee for the National Academy of Sciences for the Ohio Biomedical Third Frontier program. She has been an instructor for the University of California at Santa Cruz Extension, and Berkeley Extension where she taught a course on Advertising and Promotion in a regulated industry, and as a guest instructor for the University of Washington: Biomedical Regulatory Affairs Master’s Degree Program (Packaging, Labeling and Documentation).
Joyce received her B.S. degree in Child Psychology and Special Education Credentials from California State University at Northridge.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification