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 30th September 2009 Parental Drug Association

PDA European Workshop Offers Important Preview of EFPIA “Quality by Design” Documents

BERLIN, Germany, (September 15, 2009) - The Parenteral Drug Association (PDA) is offering delegates to its Quality by Design (QbD) workshop (Frankfurt, Germany 22/23 September 2009) an important opportunity to preview documents produced by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

The EFPIA “mock” documents (case studies) mimic a hypothetical application and reflect what would be done for a (bio-)chemical, pharmaceutical and analytical development conducted under a QbD approach for a biotech API and an injectable product. This work is being presented to PDA workshop delegates prior to presentation to European health policy-makers from the European Medicines Agency (EMEA) in London, UK on 28/29 September 2009. The documents’ authors will specifically seek input from workshop delegates on their presentations.

"The purpose of these case studies is to provide some examples of how a S2 and P2 section, respectively, might look for a parenteral product developed using an enhanced QbD development approach, as envisaged in ICH Q8R. They are not intended to be all-encompassing, and are not intended to represent the only way that development of a parenteral product can proceed, or be presented”, said Brian Whithers, Ph.D., Abbott, Director CMC Regulatory and currently Co-Chair of EFPIA's Product Development and CMC ad hoc group. “They are intended to stimulate thought and discussion of the possibilities that ICH Q8, 9 and 10 present for potential products."

Robert Schnepf, Ph.D., Head of Drug Product Formulation and Process Development of New Biological Entities at Merck KGaA, said sharing best practices with EMEA and other countries not only supports claims of regulatory relief made in the ICH documents but also helps industry as a whole fine-tune their own practices. "Much too often the potential of applying QbD is not seen or underestimated. It might be considered too complicated, implying a big workload, costing time, resources as well as precious substance and without immediate benefit. This PDA Workshop offers the opportunity to challenge all this preconceptions and to learn from the example of the EFPIA groups how much of this is true," Schnepf said.

"I personally would like to invite delegates to this PDA Workshop. The coffee table format chosen by the organising committee will help to convey the spirit and experiences of the discussions we had in our EFPIA groups", said Graham Cook, PhD, Senior Director, Process Knowledge/Quality by Design at Wyeth’s Global Quality & Compliance organization. “Everything has been designed to ensure that participants will leave satisfied and enriched by the experience, with their issues addressed and discussed with a variety of subject matter experts."

To book your place at the workshop please visit


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