Ms Carol H. Danielson, Dr PH, RAC has provided regulatory expertise and leadership for more than twenty five years for drugs, biologics and medical devices from discovery through post-marketing. Her areas of specialization include regulatory strategy and submissions, clinical affairs and compliance, and quality assurance and control. Her background includes both extensive “hands on” experience and corporate level strategy activities from partnering due diligence to serving as an expert witness in the drug development process.

Elliott T. Berger, PhD, is President of ETB Regulatory Consulting, LLC. He recently retired from BioCryst Pharmaceuticals, Inc., where he held the position of Senior Vice President of Regulatory Affairs for 14 years. He has frequently served as speaker and session chair at numerous meetings and workshops for DIA and for the Pharmaceutical Research & Manufacturers of America (PhRMA). He serves as an instructor for the DIA Regulatory Affairs: The IND, NDA, and Post-Marketing training course and is a member of the DIA Regulatory Training Committee.