PDA Announces a Landmark Workshop on QbD

For Immediate Release:  April 23, 2012
Media Inquiries: Adrienne Fierro, 301-656-5900; Fierro@pda.org

Bethesda, Md., April 23, 2012 – The Parenteral Drug Association (PDA) is coordinating a critical discussion on the implementation of QbD concepts in vaccine development.  Five vaccine manufacturers (GlaxoSmithKline, MedImmune, Merck, Pfizer and Sanofi Pasteur) have joined to form the CMC-VWG, with assistance from PricewaterhouseCoopers, to create a case study describing the development of the fictitious vaccine A-Vax.  The goal of the workshop is to initiate a discussion of the case study and to provide a review of the QbD approaches employed for the development of A-Vax.

“PDA has always allowed for unique and exciting discussions and Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop is a workshop that will bring together the big five vaccine manufactures for a unique and landmark case study review” says Sam Venugopal, Director, PricewaterhouseCoopers, LLC.  “One of the key and novel aspects of the case study is to develop and explore the application of QbD principles in vaccine development. Our hope is that the case study will help stimulate the discussions needed to help find a common understanding related to how and where QbD can be applied when developing vaccines.  More specifically, the vaccine case study proposes a hybrid approach to implementing QbD in biologics,” he added.

PDA has partnered with the consortium to disseminate the case study via public posting and to facilitate public discussion through the Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop.  While the case study will be released to the public in May, participants who attend the workshop will receive an advanced copy and detailed explanation of the study.

FDA will be present to hear the dialogue and offer their perspective on the study.

For more information, go to www.pda.org/CMC2012.

Press inquiries about registration should be directed to PDA’s Vice President of Marketing, Adrienne Fierro, fierro@pda.org.

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