Christopher Smith

Christopher Smith ,M.S., C.Q.E., R.A.C. is an expert in the field of food and drug administration. Chris has a Bachelor's degree in Biology from Michigan State / Oakland University, Rochester, MI, and a Master's degree in Microbiology from Wayne State University, Detroit, MI. He is a member of the Drug Information Association, the Regulatory Affairs Professional Society (certified RAC), the Parenteral Drug Association, the American Society for Quality (certified CQE) and is a board member of RegAffairsNC. He has several publications including "Laboratory Operations: A Vital Link," GMP Compliance, Productivity, and Quality (Interpharm Press, 1998), “Speed Dating: the Rapid Way to Phase I Clinical Studies,” PMPS Journal (Winter 2006). He is a sought-after speaker and panel participant on regulatory and quality issues affecting the pharmaceutical industry and has presented on topics including drug development, GMPs in the development setting, 505(b)(2) NDAs, Quality Systems, quality agreements, regulatory compliance, outsourcing and vendor management, stability, PAIs, and interactions with regulatory agencies. He is the Founder and President of Coastal Pharmaceutical Consultants, Inc. He has more than 35 years of experience having held senior positions at the FDA, large and small pharmaceutical companies and contract research organizations. He began his career in 1976 as an FDA Investigator and, over the course of 12 years, moved into positions of increasing responsibility in the Agency including Assistant Director of Congressional Operations, Associate Director of Program Management and Deputy Associate Commissioner for Public Affairs. In 1987, he joined Abbott Laboratories as Associate Director of Regulatory Affairs. At Abbott he was responsible for managing regulatory affairs activities including INDs, NDAs and BLAs in the neuroscience and cardiovascular therapeutic areas. In 1992, Chris moved to the CMO business as Director of Regulatory Affairs at Applied Analytical Industries soon becoming Sr. VP of Global RA and QA and a member of the Executive Committee as the company went public as AAI Inc. and expanded with the addition of clinical (CRO) services in the US, Europe, Japan and China.