David Bernstein BiographyDr. Bernstein is a regulatory and technical consultant to several biotechnology and pharmaceutical companies and provides guidance in conceptual and implementation strategy and tactics for expediting the drug development process through integrating pre-clinical formulation efforts, preparation of investigational drug supplies and scale up to commercialization activities with the clinical development plan. He is the principal liaison between numerous virtual organizations and their CMC contractors. Dr. Bernstein conducts GLP/GMP audits and has prepared numerous firms for their first FDA PAI inspections, all of whom passed this milestone. He is a frequent speaker at AAPS, DIA, PharmaConferences, GMP-by-the-Sea, RAPS and for various training courses. He has published extensively on techniques to expedite CMC drug development, effective management of multiple CMC contractors, GMPs in R&D, and GMPs for Clinical Trial Materials. He has conducted GMP training courses in the US, Japan and Europe and is the course director for several courses, "Preparation, Packaging and Labeling of Clinical Supplies", "Linking Good Science with Regulatory Expectations" and "GMPs for Clinical Trial Materials". He is the CTM/CMC Track Chairperson for the DIA Annual and Regional meetings. He is the founder of the Southern California Pharmaceutical Discussion Group, Pacific Region Clinical Supplies (PARCS) and a member of AAPS' Visiting Scientist program. In 2003, the DIA presented him with its Outstanding Achievement Award. |
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