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Preparedness for Question Based Review in Drug Approval – Role of Analytical Chemist
Monday, November 12
2:00 pm – 4:00 pm
Roundtable
ACPE #073-999-07-513-L04
In 2007 FDA intending for full-pledged implementation of Question Based Review, QBR intends to tailor the review process based on the available scientific knowledge and assessing the risk based product scrutiny with level of scientific understanding. The goal of the QBR is to provide streamlined, efficient product review based on available scientific information on the product. Key element of QBR is Quality built in by design, development, and manufacture and confirmed by testing. As part of this review process, regulatory bodies often request information specific for the product release testing and qualification of degradents and process impurities. FDA guidelines and ICH common documents shed some light into the anticipated questions. Often times the response needs to be generated from the scientists that conducted testing and release of the products. In this roundtable we examine the role of analytical chemist in responding to such inquiries enabling the sponsor company responding to the deficiencies in a rapid manner accomplishing the spirit of QBR knowledge approval.
Moderator
Prasad N. Tata, Ph.D.
Mallinckrodt, Inc.
Why We Ask Specific Questions – FDA Perspective
Lawrence Yu, Ph.D.
U.S. Food and Drug Administration
Biopharmaceutics and Toxicity Input into QBR Responses
Prakash T. Diwan, Ph.D.
Indian Institute of Chemical Technology
Experiences of Pharmaceutical Analyst on QBR
Ganapathy Mohan, Ph.D.
Sanofi-Aventis