CPSA Shanghai 2011
Changing Paradigm in Drug Discovery & Development:
East Meets West
April 13 - 16, 2011
Renaissance Shanghai Pudong Hotel
Shanghai, China
Abstract
Friday PM - Parallel Session II
Perspectives on Regional Differences in Bioanalytical Regulations
Mark Arnold
Bristol-Myers Squibb
Pharmaceutical companies need to generate and use single versions of bioanalytical data and reports for all filings. Creating custom versions to meet regional or country specific requirements creates work for not only the bioanalytical group, but also dossier managers. For many years, most countries have found the FDA and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance/guidelines; sufficient to achieve global acceptance. In the past decade, additional country-specific and regional regulations have been released and created additional burden for bioanalysts in the pharmaceutical industry and its contract research organization (CRO) partners. Harmonization of the regulations at a global-international level has been vigorously discussed at several conferences over the past year. This presentation will be in two parts. The first part of the presentation will address some regional differences and their impact and the second part will present an update on the activities of the Global Bioanalysis Consortium towards harmonized regulations.