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• PT Open Forum

Thursday, November 15

1:30 pm – 5:00 pm

Quality-by-Design: Where Does it Start?
Quality-by-Design (QbD) is part of the FDA's 'Quality in the 21st Century' initiative. QbD is an approach to developing medicinal products that seeks to define the design space within which the product has been shown during development to consistently meet the required performance specifications. Post launch, any changes to the formulation and process that are within the already defined design space would not require supplementary filings, and would simply be reported in the annual report. This Open Forum will provide an opportunity to hear speakers from different sectors of the pharmaceutical industry, and different areas of expertise discuss QbD, and how we might begin to implement it. In addition, there will be opportunity to exchange ideas through a panel-led, participatory question and answer session. The panel to be comprised of industrial members since QbD is an industry issue at the moment.

Agenda

1. Introduction/Overview - Chris Moreton
2. Preformulation Studies in the QbD paradigm - Matthew Mollan
3. Excipient Variability and QbD - Brian Carlin
4. Process Development in the Context of QbD - Richard Mannion,
5. Break (10 minutes)
6. Panel-led, participatory Q&A session (70 minutes)

An additional fee is required to attend the PT Open Forum. To register, select the appropriate registration fee under the Special Events section of the registration form.

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