FDA Policies and Practices ExpertWith 22 years of experience in senior positions with the FDA, this pharmaceutical industry expert has extensive knowledge of the FDA regulatory process and its requirements. He has been responsible for the safety and effectiveness of prescription, generic, and over-the-counter human pharmaceuticals distributed within the United States, including contrast agents. In addition to his experience with FDA, he has also served a board member for the Regulatory Affairs Advisory Board and as a consultant to the Pharmaceutical Research and Manufacturers Association.
IMS Reference #4999556 Pharmacology ExpertThis pharmaceutical industry expert has a Ph.D. in pharmacology and has been active in the pharmaceutical industry in a variety of roles for over 40 years. His experience includes employment with major pharmaceutical companies and with the FDA. His expertise includes drug advertising, labeling, and regulatory standards. He has also helped sponsors develop plans for drug advertising pieces as well as providing help with the acquisition of reasonable compounds for the U.S. market. He has published many papers in the area of FDA regulations and pharmacology. He has also given lectures on regulatory issues and how to prepare IND’s, NDA’s and Abbreviated New Drug Applications (ANDA’s).
IMS Reference #5002759 Pharmaceutical Sales ExpertThis pharmaceutical industry specialist has a masters degree in life sciences and over twenty-five years of experience with pharmaceutical, biotechnology, medical supply, and healthcare technology companies. His entire career has been in the pharmaceutical and medical device fields, in a variety of sales and marketing roles. He has been a consultant to the pharmaceutical industry and to numerous technology companies establishing new markets within the healthcare industry. His recent company experience includes business planning and market research, managed care, and sales.
IMS Reference #5003126
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