Stevens Institute of Technology
Howe School of Technology Management
Syllabus
MGT 684
Regulation & Compliance in the
Pharmaceutical Industry
Semester: 2012
Day of Week/Time: WebCampus
Instructor Name & Contact Information:
Elaine Lehecka Pratt
elaine.pratt@stevens.edu
201-216-5062
Office Hours:
Wednesday and Thursday, 1-3 pm
Class Website:
Overview
This course explores the economic theory of regulation in general, and the US and
international regulatory environments that govern the pharmaceutical and biotechnology
industries with particular focus on the US Food and Drug Administration, the European
Agency for the Evaluation of Medical Products and the Japanese Ministry of Health,
Labor and Welfare. The essential components of Good Laboratory Practices, Good
Clinical Practices and Good Manufacturing Practices regulations will be covered.
Students will develop an understanding of the formulation and execution of regulatory
strategy and key ethical issues in medical research and production. Where appropriate,
case studies will be used to illustrate the challenges and issues associated with
compliance as well as the consequences of noncompliance. Ethical issues and the
potential consequences of ethical lapses will also be explored. Current events will be
used to illustrate key ethical principles and serve as a basis for discussion.
Prerequisites: None.
Relationship of Course to Rest of Curriculum
This is an elective course in the Pharmaceutical Technology Management Program. It
can be taken by students pursuing a Graduate Certificate in Pharmaceutical Technology
Management. It is also cross-listed in the Pharmaceutical Manufacturing program and is
an elective course in the Validation and Regulatory Affairs Graduate Certificate.
Learning Goals
After successfully completing this course, students will be able to
1. Appraise economic theories of regulation to determine application to the
pharmaceutical industry
2. Analyze US and international regulatory requirements and strategize management
challenges for compliance
3. Evaluate the role of ethics in pharmaceutical regulation and compliance
Pedagogy
The course employs lectures, class discussions, in-class assignments, homework, team
projects, and an individual research term paper. Students will make several formal
presentations during the class.
Required Text(s)
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and
Biologics, 2nd edition, edited by Douglas Pisano and David Mantus, published by Informa
Healthcare, 2008, ISBN 978-142007354-6
Research Ethics: A Reader, edited by Deni Elliot and Judy Stern, University Press of
New England, 1997, ISBN 0874517974
Additional Readings
Will be assigned during the course.
Assignments
Readings will be assigned each week for in class analysis and discussion. Students are
expected to come to class each week prepared to discuss the readings and cases, and to
participate fully in the preparation and presentation of team project assignments. Specific
assignments include:
1. Student Team Presentation 1: Regulatory Submissions – Requirements and
Strategy
Working in teams, students will be research an assigned international regulatory
submission. They will create a presentation highlighting the regulatory
submission requirements, timeline, and content topics, and the strategy and
staffing expertise needed to accomplish the submission.
15 % of final grade (including individual and team grade components)
2. Student Team Presentation 2: Consequences of Noncompliance
Working in teams, students will be assigned a case study for evaluation. They
will create a presentation summarizing the situation, contributing factors,
corrective and preventive action ideas, and specific recommendations of future
strategies.
15 % of final grade (including individual and team grade components)
2
3. Student Team Presentation 3: Consequences of Ethical Lapses
Working in teams, students will be assigned a case study for evaluation. They
will create a presentation summarizing the situation, contributing factors, an
analysis using a model for ethical decision making, corrective and preventive
action ideas, and specific recommendations of future strategies.
15 % of final grade (including individual and team grade components)
4. Final Paper
Each student will select an aspect of regulatory compliance and prepare a 15 page
research paper which explores the impact of the requirements on the process (e.g.
– research and development, clinical trials, production, etc.), the economic cost of
regulatory compliance, the functions and staffing necessary to meet the
requirements, a short term regulatory compliance goals, corrective and preventive
action plans for compliance, the use of technology in achieving compliance goals,
and the development of an overall strategy for maintaining regulatory compliance.
Guidance for the paper will be provided.
25 % of final grade
5. Class Participation in Weekly Discussions
Each student is expected to attend all classes, to have completed the assigned
readings and prepared the assigned case studies or other work, and to contribute
thoughtfully to the class discussions.
20 % of final grade
6. Final Exam
The final exam is the final synthesis of course information by means of several
presented scenarios for which the student must formulate an appropriate response
with sufficient detail, drawing on the material presented in the course.
10% of final grade
3
Ethical Conduct
The following statement is printed in the Stevens Graduate Catalog and applies to all
students taking Stevens courses, on and off campus.
“Cheating during in-class tests or take-home examinations or homework is, of course,
illegal and immoral. A Graduate Academic Evaluation Board exists to investigate
academic improprieties, conduct hearings, and determine any necessary actions. The
term ‘academic impropriety’ is meant to include, but is not limited to, cheating on
homework, during in-class or take home examinations and plagiarism.“
Consequences of academic impropriety are severe, ranging from receiving an “F” in a
course, to a warning from the Dean of the Graduate School, which becomes a part of the
permanent student record, to expulsion.
Reference:
The Graduate Student Handbook, Academic Year 2003-2004 Stevens
Institute of Technology, page 10.
Consistent with the above statements, all homework exercises, tests and exams that are
designated as individual assignments MUST contain the following signed statement
before they can be accepted for grading.
____________________________________________________________________
I pledge on my honor that I have not given or received any unauthorized assistance on
this assignment/examination. I further pledge that I have not copied any material from a
book, article, the Internet or any other source except where I have expressly cited the
source.
Signature ________________
Date: _____________
Please note that assignments in this class may be submitted to www.turnitin.com, a webbased anti-plagiarism system, for an evaluation of their originality.
4
Course Schedule
Week
1
2
3
4
Topic(s)
Introduction to the Pharmaceutical
Regulated Environment
 Theories of regulation
o Public interest or “market
failure” theory
o Capture theory
o Economic theory
o Public choice “theory”
 Background and history of
pharmaceutical regulation
 Stages of discovery, development,
approval, marketing, and postmarketing, and where regulation
fits in the stages of the drug product
lifecycle
 FDA regulatory enforcement and
consequences of noncompliance
 Economic impact of regulatory
compliance
The US Regulatory Environment
 Nonclinical laboratory studies
(GLP)
 Clinical trials (GCP)
 Pharmaceutical production (GMP)
 Management issues: Managing
regulatory compliance and its costs
The US Regulatory Environment continued
 Medical device design and
production (QSR)
 Validation
 Post-marketing pharmacovigilance
 Management issues: Managing
regulatory compliance and its costs
Product Submissions
 Approval process
 Regulatory strategy
 Meeting with the agency
 PAIs (pre-approval inspections) and
on-going inspections
 Inspection response strategies
 Internal audits
Assignments



“What is Regulation and
Why Do We Do It?” by Susan
Dudley,
http://www.mercatus.org/regrad
ar/subcategory.php/301.html
“The Theory of Economic
Regulation” by George Stigler,
http://www2.susu.edu/faculty/w
atkins/stigler.htm
Pisano/Mantus – Chapter 1

Pisano/Mantus – Chapters 9,
10





Case Study –
BioDevelopment Associates
Warning Letter,
www.fda.gov/foi/warning_
letters/g4811d.htm
Pisano/Mantus – Chapter 7
Case Study – GE Warning
Letter,
www.fda.gov/foi/warning_
letters/g5280d.htm
Pisano/Mantus – Chapters 2-5
Case Study – C.R. Bard
Warning Letter,
www.fda.gov/foi/warning_
letters/g4797d.htm
5

5
6
7
8
9
Management issues: Managing
regulatory compliance and its costs
Team Presentations: Regulatory
Submissions – Requirements and Strategy
 IND (Investigational New Drug
Application)
 NDA/ANDA (New Drug
Application, Abbreviated New
Drug Application)
 BLA (Biologics License
Application)
 PMA/510(k) (Pre-market Approval
Application)
Compliance Strategy for Electronic
Technology Management
 21 CFR Part 11 (Electronic Records
and Electronic Signatures)
 eCTD (electronic common
technical document) submissions
 CSV (computer system validation)
issues
 Management issues: The economic
impact of regulatory compliance
The International Regulatory Environment
 European Union
 Japan
 ISO (International Organization for
Standardization)
 ICH (International Committee on
Harmonization)
 GHTF (Global Harmonization Task
Force)
 Management issues: The economic
impact of global marketing
Team Presentations: Consequences of
Noncompliance
 Barr Laboratories decision
 Abbott consent decree
 Schering-Plough consent decree
 MIT Biomedical Engineering
Center warning letter
Practice and Components of Regulatory
Affairs and Compliance
 Quality management system
planning
 Quality management system control

Student Team Presentations


Pisano/Mantus – Chapter 11
www.fda.gov/cder/regulatory/
ersr/ectd.htm
www.fda.gov/cder/meeting/
eCTD4_2005.htm

References for lecture:
 http://pharmacos.eudra.org/F2/e
udralex/index.htm (Volume 4 GMP)
 http://www.jpma.or.jp/12englis
h/parj/index.html
 www.iso.org
 www.ich.org
 www.ghtf.org

Student Team Presentations

Pisano/Mantus – Chapter 12
6

10
11
12
13
14
Technology controls for
compliance
 Management issues: Managing
regulatory compliance and its costs
Introduction to Ethics in Medical Research
 The Baltimore case
 The CalTech case
 The Nuremberg Code and the
Helsinki Declaration
 Ethics in clinical trials
Introduction to Ethics in Pharmaceutical
Validation, Quality Assurance, Production
and Post-Marketing Pharmacovigilance
Team Presentations: Consequences of
Ethical Lapses
 Dr Bishop warning letter case
 Elliott/Stern case pp 109 – The
New Technician
 Elliott/Stern case pp 297 – Case 3
 Bristol-Myers Squibb DTC warning
letter case
The Future of Regulation and Compliance
 Harmonization of regulations
 FDA 21st century initiatives
 Risk-based management
 Impact of future technology on
compliance
Term Papers Due, Final Exam

Elliott/Stern – pp 11-17, 20-33,
43-59, 60-68, 286-294, 300-306
 Case Study – Data Selection,
Legitimate or Illegitimate?,
http://onlineethics.org/cases/
nspe/ec85-5.html
 Elliott/Stern – pp 174-186, 193196, 218-221, 242

Student Team Presentations

http://www.fda.gov/cder/gmp/g
mp2004/GMP_finalreport2004.
htm
7