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Regulatory Affairs: The IND, NDA, and Post-Marketing

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.


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  • Drusilla  Scott

    Drusilla Scott

    • Vice President, Regulatory Affairs
    • BDSI, 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.

  • Carol H. Danielson, DrPH, MS, RAC

    Carol H. Danielson, DrPH, MS, RAC

    • President
    • 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.

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