140.633.11 | AY 2013-2014 - Summer Inst. Term | 2 Credit(s)
MTWThF 8:30:00 AM
  • Contact Information
    Mary Foulkes
  • Course Learning Objectives

    Upon successfully completing this course, students will be able to:

    • Explain the relevance and application of statistics to the regulatory process; Differentiate between well-designed and conducted clinical research in the development and evaluation of new medical products; Locate internet sources for regulatory requirements, and regulatory review and evaluation information
  • Course Description

    This course addresses the application of many principles of biostatistics in the context of medical product development and regulation. The material presented will provide you with a basis for understanding international regulation as outlined in various guidance documents. The presentations and discussions provide opportunities to learn about applications to study design, conduct, analyses, and inferences. We will present examples of products, product development processes, and opportunities for innovation in global product development.

  • Intended Audience

    Pharmaceutical industry professionals and interested degree seeking students within the School.

  • Methods of Assessment

    Class quizzes and  exercises

  • Prerequisites

    The intended audience are graduate students in clinical medicine and public health interested in regulatory applications or medical product development professionals (e.g., the biologics, medical device, or pharmaceutical industry).

    Prerequisite courses in basic biostatistics or epidemiology such as . . .

    • Principles of Epidemiology
    • Statistical Reasoning I or II
    • Fundamentals of Epidemiology


  • Course Schedule

    Please see the course Session for a full list of dates and items for this course.

  • Academic Ethics Code

    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

  • Disability Support Services
    If you are a student with a documented disability who requires an academic accommodation, please contact the Office of Student Life Services at 410-955-3034 or via email at