BionorthTX RA/QA Committee presents Betty Holland, President, BCH Regs, Inc. “Drug Development: IND Process” Thursday, February 8th, from 5:30PM – 8:00PM
Betty Holland has over 35 years of experience in drug development, including chemical research, scientific writing, project management and more than 20 years in regulatory affairs. She has experience working in both large pharma and startup biotech companies, and more recently has served as a consultant to startup biotech companies, both to define and implement regulatory strategy. She has a Master of Science degree in Organic Chemistry from Purdue University and currently serves as President of BCH Regs, Inc., a regulatory consulting company
Betty will overview the IND portion of the new drug development process in the United States, outline the FDA Organization, describe various phases of drug development and information to be submitted, clinical trials, FDA Meetings, and discuss programs for expedited development for serious conditions.
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