International Pharmaceutical Quality and related IPQ publications will target the issues and challenges surrounding the international harmonization of pharmaceutical and biopharmaceutical regulation and help further the discussion about the regulatory approaches appropriate for advancing products and processes. Each issue will provide an in-depth analysis of a key problem area or developing regulatory initiative. IPQ will seek to improve understanding of the issues and to aid the development of harmonized global CMC and GMP policies and corporate quality systems.

"The goal of the publication is to delve into and advance the current dialogue between industry and regulators on evolving the paradigm for regulating drug and biotech product quality," explains IPQ's Editor-in-Chief Bill Paulson. "IPQ will help its readers understand the changing regulatory environment and be more actively involved in shaping the outcome."

IPQ staff will maintain editorial independence and will report on key conferences and workshops where proposals for industry and regulatory guidances and initiatives are being presented. As a driver of the evolving regulatory model and the harmonization effort, the U.S. Food and Drug Administration (FDA) will be an important component of IPQ's coverage. Also included in the publication's purview will be international quality initiatives and harmonization efforts involving industry associations, regulatory agencies, pharmacopeias and standard-setting organizations around the globe.