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

Attend this virtual training course to learn about FDA regulations and expectations for the content, submission and review of INDs and NDAs, and the importance of regulatory strategy.


Faculty

  • Elliott T. Berger, PhD, MS

    Elliott T. Berger, PhD, MS

    • President
    • ETB REGULATORY CONSULTING LLC, United States

    Dr. Berger has more than three decades of pharmaceutical industry experience, primarily in the Regulatory and Biostatistics areas. Prior to joining BioCryst, he held senior regulatory affairs positions with a number of companies. Most recently, he served as Vice President of Regulatory Affairs and Quality Assurance at EMD Pharmaceuticals, the US affiliate of Merck KGaA, Darmstadt, Germany with responsibility for leading the US Regulatory Affairs and Quality Assurance Groups, as well as the Global Regulatory Strategy function. He was an active member of the PMA (PhRMA) Working Group for Computer Assisted NDA Review (CANDAR) from its 1984 inception through 1992, serving as Working Group Chairman from 1988 to 1990.

  • Drusilla  Scott

    Drusilla Scott

    • 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.

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