PDA European workshop offers chance to preview EFPIA Quality by Design documents

The Parenteral Drug Association (PDA) is offering delegates to its Quality by Design (QbD) workshop an important opportunity to preview documents produced by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

The workshop will take place on 22-23 September in Frankfurt, Germany.

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. 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," said Dr Brian Whithers, Abbott, director CMC regulatory and currently co-chair of EFPIA's product development and CMC ad hoc group.

"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. They are intended to stimulate thought and discussion of the possibilities that ICH Q8, 9 and 10 present for potential products."

Dr Robert Schnepf, 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 its own practices.

"Much too often the potential of applying QbD is not seen or is underestimated. It might be considered too complicated, implying a big workload, costing time, resources as well as precious substance and without immediate benefit," Schnepf said. "This PDA workshop offers the opportunity to challenge all these preconceptions and to learn from the example of the EFPIA groups how much of this is true."

"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 Dr Graham Cook, senior director, process knowledge/Quality by Design at Wyeth's Global Quality & Compliance organisation. "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."

Workshop places can be booked at www.pda.org/QbD2009.