Regulatory Affairs: The IND, NDA, and Post-Marketing
Carol H. Danielson, DrPH, MS, RAC
- Regulatory Advantage, LLC, United States
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.
- Vice President, Regulatory Affairs
- Dova Pharmaceuticals, United States
Dr. Scott has more than 30 years of experience in drug regulatory affairs in the pharmaceutical industry, and is currently at BDSI, a specialty pharmaceutical company focused in pain and addiction. She has served in a number of companies as a principal in constructing clinical regulatory strategies and submissions for the development of products across a range of therapeutic areas, with a focus on anti-infective drugs. She is also a certified paralegal with primary interests in administrative law and intellectual property.