GVSU-MSU Clinical Research Trials Management Certificate Program

Course Title                       PHM 659 –

Regulatory Affairs and Project Management in

Clinical Research

                                                               

Prerequisite                       None

Required Text                    Drug and Biological Development

From Molecule to Product and Beyond

(Editor – Ronald P. Evens)

Meredith, J. R., and Mantel, S. J., Project Management: A Managerial Approach, 6th edition, Wiley, 2006. (7th or 8th editions are encouraged).              

Course Description

This course involves principles and activities in drug development, the regulatory process for obtaining marketing authorization, the fundamental aspects of project management including work breakdown structure, scheduling, earned value analysis, and risk management.

This course is for students enrolled in the Certificate in Clinical Research Trials Management - Program in Public Health, College of Human Medicine at MSU.  It is not open to students with credit in PHM 857 or PHM 858.

Course Objectives

The primary objectives for the course are listed below:

 

  • Provide an overview of the development of prescription pharmaceuticals from discovery of a new chemical/molecular entity to nonclinical/clinical studies through obtaining marketing authorization and maintenance of an approved product.
  • To introduce and discuss the political environment, governmental impact and regulatory framework surrounding the pharmaceutical industry and the development of prescription drugs.
  • To identify key principles of project management, scientific decision making and understanding of the global regulatory environment and integrate the principles into practical models for clinical research and drug development.
  • Formal project management culture, principles, knowledgeable areas, and terminology
  • Specific tools and techniques, including work breakdown structure, earned value analysis, risk management, and quality control for managing scientific research
  • Introduction to work planning; estimating, assigning and integrative resources
  • Introduction to risk management and quality management
  • Risk management in commercial biomedical research
  • Decision-making and problem-solving for drug development projects
  • Portfolio management for prioritizing biotech and life sciences
  • Managing projects throughout the drug development lifecycle

 

Grading

The course is divided into two main sections – (1) regulatory / drug development and (2) project management.  At the end of each six week section, there will be a comprehensive examination utilized to determine the students’ ability to integrate the information presented in the course. 

Students are responsible for material assigned from the selected readings.  Class lectures/slides are designed to supplement, augment, and clarify the knowledge base obtained from reading the text material.  The lectures are not substitutes for the reading assignments and vice versa.

The course outline is listed below.  To allow students sufficient time for discussion and exams, the sessions run on a two-week schedule.  Each session will be made available no later than 10 am EST, the Tuesday of the session beginning (Day 1).  Each session will involve reading and discussion board posts; some sessions also contain homework exercises or exams.  Students will be expected to make at least one discussion board post related to Discussion Topic by Wednesday of the following week (Day 9).  Students are expected to provide feedback on the posts of other students by Monday (Day 13).  Use of the discussion board for additional questions or feedback to me or your classmates beyond the Discussion Topic to simulate standard class room questions or discussion is also encouraged.

 

Course Outline  -  Fall 2012

 

 Session

Subject

Reading

 

1

Parker

Industry Overview

  • Overview of pharmaceutical industry, role of pharmaceuticals, stakeholders
  • History drug regulation
  • Portfolio Management and Discovery

 

2

Parker

Research and Early Development

  • IP, Nonclinical testing and pharmaceutics
  • IND development and clinical phases
  • (Exercise #1)

 

3

Parker

Full / Late-stage Development

  • Clinical studies, GCPs and safety
  •  (Exercise #2)

 

4

Parker

Special Considerations

  • Development issues – Outcomes research, Orphan Drugs, Pediatrics, Abuse Liability
  • Labeling and drug names

 

5

Parker

Registration
  • NDAs and CTDs
  • FDA and Dossier Review process
  • Standard/priority reviews, Advisory Committees, Agency meetings

 

6

Parker

Commercialization

  • Launch activities, risk management and product defense
  • Post-approval activities, life cycle management and new indications

 

7

Exam #1

 

8

Herzig

Work Planning & Work Breakdown Structure

  • Planning the project
  • Building work packages and WBSs

 

9

Herzig

 Project Scheduling & Estimating

  • Network diagrams
  • Gantt charts

 

10

Herzig

Integrating Resources, Costs, and Schedules

  • Crashing
  • Resource loading and leveling
  • (Exercise #3)

 

11

Herzig

Monitoring, Evaluating, and Control

  • Earned Value
  • Maintaining schedule and cost

 

12

Herzig

Project Risk and Quality Management

  • Assessing project risk
  • Quality assessment
  • (Exercise #4)

 

13

Herzig

Project Termination and Closeout

  • Closeout reports and lessons learned

 

14

Exam #2

 

15

Final Exam

 

 

 

Communication Guidelines

 

We will try to check the discussion board every day or two.  For discussions, post your comments and questions to that module’s discussion board. Students are encouraged to collaborate by sharing discussions and thoughts on the material and learnings through the Angel system.  However, for exams and assignments, students are expected to perform the work themselves and are referred to the University’s policies on Conduct and Academic Integrity (see section below).

 

Changes may occur to the syllabus, due dates of assignments/exams.  These changes will be posted in the Angel system.

 

For any urgent communication to either of us, please contact us via our e-mail or phone number provided in the syllabus.

 

Policy on Late Assignments, Make Up Exams and Extra Credit

 

Students are expected to meet the deadlines for assignments, discussion postings and exams.  Late assignments will be penalized for each assignment or activity that is late.  Assignments will not be accepted after they are 7 or more days late without prior notification/arrangement.  However, it is understood that there are times when scheduling conflicts occur and make-up exams are possible.  If a scheduling conflict arises, you must contact us in advance to arrange an alternate due date.

 

There will be no provision for extra credit assignments or work. 

Academic Integrity
Article III.B.2 of the Academic Freedom Report states that "The student shares with the faculty the responsibility for maintaining the integrity of scholarship, grades, and professional standards." (http://splife.studentlife.msu.edu/academic-freedom-for-students-at-michigan-state-university).  The general expectations for all students (graduate, undergraduate, professional, and lifelong education) enrolled in online PHM courses (ie, offered by the Department of Pharmacology and Toxicology) for maintaining academic integrity are outlined below.

Independent Work
Students are expected to work independently on all assignments for which they receive a grade. This includes all types of assessments: tests, examinations, quizzes, homework, projects, problem sets, and any other assessment assigned by the instructor. The answers you submit must be your own and may not be copied from any source. You may not submit course work for which you have received credit in another course to satisfy the requirements for a course you are currently taking. All exceptions to this policy will be specified by your instructor. If you have any doubt as to whether or not working together or using outside resources and references is permitted to complete an assignment, ask your instructor.

When taking tests, examinations, or quizzes, no class notes, books, or other resources may be used, and you may not discuss the questions with your classmates. Outside assistance of any type is not permitted. Any exceptions to this policy will be stated explicitly by your instructor.

Plagiarism
Plagiarism is using someone else’s ideas or words without crediting the source. If you copy someone else’s words directly, those words must be enclosed within quotation marks and cited; the thoughts of others, written in your own words, must be cited. This is true regardless of the source – books, journal articles, and web pages all must be cited if you use ideas or words from them. Source can be hard copy or electronic, and the author might not be identified. Regardless of the details, you must cite your source in such a way that it can be found by someone else.

Plagiarism is considered to be academic theft, and committing plagiarism is a significant violation of MSU academic integrity policies. Students who plagiarize any part of an assignment may receive a penalty, including, but not limited to, a failing grade on the assignment or a failing grade in the course; expulsion from the program is possible.

MSU Policies
The Department of Pharmacology & Toxicology adheres to all applicable MSU policies as outlined in Policies, Regulations and Ordinances Regarding Academic Honesty and Integrity (https://www.msu.edu/unit/ombud/RegsOrdsPolicies.html). In addition, the Department of Pharmacology & Toxicology adheres to the all-university policy on Integrity of Scholarship and Grades and Ordinance 17.00, Examinations as outlined in Spartan Life Online (http://splife.studentlife.msu.edu/) and/or the MSU Web site (http://www.msu.edu.).

 

 

Page last modified June 14, 2012