SUNNYVALE, Calif., Aug. 30 /PRNewswire/ -- Conformia, one of the FDA's Cooperative Research and Development Agreement (CRADA) Partners, joined forces with the Food and Drug Administration (FDA) on August 23, 2007, in a presentation focusing on the FDA's Quality by Design (QbD) initiative at the Third Annual Regulatory and Compliance Symposium -- "Managing Risks -- From Pipeline to Patient." The symposium was held at Harvard University.
Helen Winkle, Director of the Office of Pharmaceutical Sciences, a part of the Center for Drug Evaluation and Research, shared the progress the FDA is making, as well as the challenges that both the FDA and the industry face in moving to the "desired state." Winkle pointed out that Chemistry Manufacturing and Controls (CMC) requirements are part of the critical path both within the FDA and within industry, and described how the Quality by Design (QbD) initiative is created to help reduce excessive regulatory burden and provide mechanisms for regulatory flexibility.
Anjali Kataria, principal investigator of the FDA-Conformia Cooperative Research and Development Agreement (CRADA) study, presented research from the CRADA study of nine blinded pharmaceutical / biotech companies. She highlighted results including the bottlenecks and obstacles companies face in implementing QbD, as well as the top priorities study companies articulated -- such as gaining more assurance from the FDA that reviewers, inspectors and policy makers are all being trained to support the "desired state."
Winkle and Kataria presented both findings and actions resulting from part one of the Conformia CRADA study that queried pharmaceutical and biotech leaders about meeting the goals of the FDA's QbD initiative. The preliminary findings led to an expanded CRADA study and a series of first-of-a-kind Conformia-FDA-PhRMA trainings for cross-functional pharmaceutical leadership teams.
The Harvard presentation focused on:
-- The state of
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