Biostatistics in Medical Product Regulation 



 
 November 24, 2009

 
Course Syllabus

Course Description | Course Objectives | Prerequisites | Course Format | Grading Policy | Contact Information | Help | Ethical Conduct


 

Course Description

Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.


Course Objectives

Understanding the relevance and application of statistics and of statistical thinking to the regulatory process; an understanding of the basic principles of clinical studies and clinical trials, and their importance to the regulatory evaluation of new drugs, biologics and devices; and an awareness of sources of regulatory guidance, requirements, and evaluation information.

Prerequisites

Intended audience is 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 Format

The content of this course is presented in a combination of lectures, discussions, and LiveTalk sessions. You are responsible for reading the course materials, participating in the LiveTalk sessions, quizzes and final exam.

Required readings are available via the Welch Medical Library E-Reserves, Web Links, and the Online Library. Please refer to the reading list (on each lecture page) for location of documents.

Grading Policy

Quizzes: 15%
Exam: 75%
Participation/Discussion: 10%

Grading Restrictions: Pass/Fail 		 

Contact Information

Mary Foulkes
Research Professor
Department of Epidemiology and Biostatistics
George Washington University
6110 Executive Blvd, Suite 750 Rockville, MD 20852
Phone: 301-881-9260
email: mfoulkes@jhsph.edu

Simon Day
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW  United Kingdom
Phone: +44 (0)1707 366409
email: simon.day@roche.com

Simina Boca (TA)
Department of Biostatistics
Room E3032, 615 N. Wolfe Street
Baltimore, MD 21205
Email: sboca@jhsph.edu


Help

Concerns
Contact
Concerns about course topics and assignments
  • TA
Technical concerns about the functionality and operation of course Web pages (before emailing, please make sure that you can replicate the problem)
  • DEHelp, the central help system for all tech support inquiries related to DED courses
Technical help on weekends
  • JHSPH User Support: 410-955-3781
Concerns about your Internet connection
  • Your Internet service provider (e.g., AT&T, Erols, etc.)
Concerns about your personal software
  • Your software vendor


Ethical Conduct

The academic ethics code, as discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class.


Disability Support Services

If you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Career Services and Disability Support: dss@jhsph.edu, 410-955-3034, or Room E-1140.

 

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