Vinod P. Shah Ph.D. is a pharmaceutical consultant. Dr Shah is the Scientific Secretary, a member, and a Fellow of the Executive Council of International Pharmaceutical Federation (FIP).Dr. Shah, a Senior Research Scientist for the US Food and Drug Administration (FDA) retired in July 2005, after 30 years of service. During his tenure, he developed Regulatory Guidance for the Pharmaceutical Industry. He received several FDA Awards for Leadership Excellence, Team Excellence and Excellence in Communication, as well as the FDA Award of Merit, FDA Scientific Achievement Award and FDA Distinguished Career Service Award. Dr. Shah is an Adjunct Professor at University of Kentucky, Lexington KY, (2001-present). He has authored or co-authored over 210 scientific papers and is a co-editor of three books. Dr. Shah was President of The American Association of Pharmaceutical Scientists (AAPS) in 2003. He is a recipient of an AAPS Distinguished Service Award, an AAPS Fellow, and serves on the Editorial Board of AAPS PharmSciTech.