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Course Syllabus
This course syllabus is a general plan for the course; deviations
announced to the class by the instructor my be necessary .
In .pdf format
Contents:
UGA Faculty and
Staff
Course Coordinator :
Name: David
W. Mullis, Jr., Ph.D., RAC, Director Regulatory Affairs Graduate Education
Program
Email:
Office
location: B2340 Georgia Gwinnett College
Office hours: Mon. &
Fri. 9:00 am to 2:00 pm , Tues 9:00 am-Noon
Phone & Fax:
Course Support (including technical
support):
Johnna Hodges, M. Ed., Program Manager
Email:or Phone &
Fax:
Angie McVey, Program Coordinator
Email: or Phone & Fax:
When emailing faculty and staff, please allow a reply time of 24-48
hours if you submit your email during the week. If you submit a question
over the weekend, please allow additional response time.
Course Instructional
Staff:
David W. Mullis, Jr., Ph.D., RAC
Director, Regulatory Affairs
Graduate Education Program
College of Pharmacy
University of
Georgia
Robert C. Coleman
Investigator, National Drug Expert
Food and
Drug Administration
Laurie Farmer
Special Assistant, Southeast Region
Food and
Drug Administration
Gary Dykstra
Director, Southeast Region
Food and Drug
Administration
Robert P. Ryan, Ph.D.
Vice President, Regulatory Affairs
Atherogenics, Inc.
Felipe Dolz, DVM
Executive Director, Regulatory Affairs
NA/International
Merial
Wayne Wiley, R.Ph.
Senior Director, Regulatory Affairs
Elan
Drug Delivery, Inc.
Course Description:
PHAR 6010 is one of the core courses required for the
certificate program and/or for the Master of Science Degree in Pharmacy
with an emphasis in regulatory affairs. This course provides an
introduction to the pharmaceutical, biotechnology and medical devices
industries. The primary goal of this course is to provide the foundational
information to allow a student to develop a basic knowledge and
understanding of the pharmaceutical, biotechnology and medical devices
industries from a regulatory affairs perspective.
Students will need this course content information to support further
study and to perform the tasks required of regulatory affairs
professionals. The course will provide an overview of company
organizations, product development and commercialization activities with
an emphasis on regulatory requirements.
Prerequisites: Permission of Department
Course
Objectives:
Upon completion of PHAR 6010, students will be
able to demonstrate:
- An understanding of the product development process including:
- Describing various approaches to product development
- Discussing the interrelationships among the different
functional or departments involved in the product development process
- Summarizing the impact of the regulatory process on the product
development process
- An understanding of the Food and Drug Administration, including:
- A history of key regulations
- The development and evolution of the FDA regulatory process
- The FDA organization and functional components
- Interactions between and among FDA Centers
- The principles and general approaches required to obtain FDA
clearance to market new products
- How to use selected FDA reference documents and links to
websites
- An understanding of the basic operational differences and
similarities of pharmaceutical, biotechnology and medical device
companies including:
- Impact on the economy
- Effect of globalization on various industries
- The ability to locate reference materials required by students
working as regulatory affairs professionals
- An appreciation for the subjective and interpretative aspects of
regulations and the ability to think critically about the interaction
between regulatory applications and product development.
Course Materials and
Recommended Reading:
Readings: There is no required
text book for this course. The readings will come from a bibliography list
and many of these will be available from the internet or library.
Typically, the instructor will provide a recommended reading list on a
weekly basis.
Recommendation: We recommend the purchase of US RA
Acronyms & Definitions PG 2004 (or the most recent edition). It
is a pocket guide that contains over 1,250 acronyms, terms and definitions
most commonly used by regulatory affairs professionals. It can be
purchased through the Regulatory Affairs Professional Society, http://www.raps.org/. The cost is $12.00
for nonmembers and $10.00 for members.
Materials: A
variety of materials and methods will be employed in providing the
information for PHAR 6010. These may include audio tapes, lectures, power
point presentations, reading materials and interactive exercises.
Assignments:
1) Autobiographical Summary
Please write a brief
autobiographical summary to share with your class and faculty. Some
areas to include might be as follow:
- Current employer.
- Describe your role or position.
- How did you achieve your current position (significant assignments
or mobs, schooling, etc.)?
- What interests you most about the regulatory affairs field?
- List your professional goals, both short and longer term.
- Share other personal information about interests, hobbies, etc.
This autobiographical summary should be submitted on or
before January 22, 2005 through the WebCT Email format. Please send to
both Dr. Mullis and Johnna Hodges.
2) Major Research Project: Company Profile
You are to choose a company in the pharmaceutical, biologics, biotech
or medical devices industry that interests you. Please choose a company
that is in a different field from which you are presently employed.
You are to conduct an in-depth study of that company’s background,
marketplace position, research and development approach and regulatory
history. Your research will typically involve searching the company’s
website for general information about the company, reviewing annual
reports, and contacting the company directly to arrange a brief
interview with someone like the VP/Director of Research and Development,
Director of New Product Development and/or Director of Marketing. You
may also try to communicate with the head of regulatory affairs to gain
insight into how the company interacts with FDA and other regulatory
agencies.
You will submit a written report on the chosen company. Your paper or
report should include the following information:
- History of the company (How long in business, private or public
and major products marketed?)
- Technology platform of product(s) (drugs, biologics, vaccines,
cells, devices).
- Company’s state of development (e.g., research only, marketing
products or fully vertically integrated).
- Describe the company’s product development plan or approach to
creating new products (How are new products screened, reviewed and
approved internally?)
- How does the company accomplish each of the key tasks:
- Discovery (chemistry, engineering, pharmacology)
- Preclinical research (scope and how it is performed)
- Regulatory Pathways (IND, IDE, NDA, PMA, BLA)
- Clinical research overview (what tasks are handled internally
and what are contracted to outside firms or CROs)
- Provide a summary of the products that the company currently has
marketed.
- Regulatory Profile
Review and summarize information pertaining to FDA interactions
with the company that are available in the public domain. This will
include reviewing the FDA websites for possible product approvals over
the past two to three years, warning letters, establishment
inspections reports including FDA Form 483s and/or product
recalls.
Using what you have learned in this course, please provide
recommendation for how the company could positively impact or improve
its product development process and regulatory approach for bringing
new products to the US marketplace.
Your paper should be double spaced, 12 point font and be 10-15 pages
in length excluding tables, graphs, pictures and
references.
This research paper is due on or before May 1, 2005 11:55
p.m. May 7 will be devoted to student project presentations. Use WebCT
to submit this written assignment.
Student papers are now due on Sunday, May 1st. Please submit that
paper using the WebCT submission tool. All the student presentation will
now occur on Saturday, May 7th. We will begin the May 7th session at
8:30 am and go until all student presentations are complete.
Each student presentation should be approximately 30 minutes. Please
plan the narrative part to be 20 minutes and allow about 10 minutes for
discussion.
If you plan to use MS PowerPoint to supplement your talk, please let
either Angie or Johnna know. If you have any other technical
requirements, let us know BEFORE May 7th.
3) Web Exercises
During most weeks of the course, you will be required to complete web
exercises that involve your searching for and reviewing materials on the
FDA web site. The goal of these exercises is to help you become familiar
with references available on the web and to help you learn some search
tools/techniques when faced with new product issues. Some of these
exercises may include brief essays that require you to synthesize,
interpret or draw conclusions about the materials that your have bee
reading and receiving during class sessions.
Grading:
Grading will be based on the following scale:
100-point scale Grade:
| 100-94 = A |
93-90 = A- |
89-88 = B+ |
87-84 = B |
83-80 = B- |
79-78 = C+ |
77-74 = C |
73-70 = C- |
69< D |
59< F |
Grading will be based on each student completing special assignments
that are made during the course including web exercises, discussion
boards and quizzes, as applicable, and a major project: Company Profile
plus its presentation to the class. The following provides weighting for
each activity:
| • Online and Class Participation (Web Exercises and
Quizzes) |
40% |
| • Written Paper on Company Profile |
40% |
| • Presentation of Paper to Class |
20% |
| |
100% |
Policies and Academic Honesty:
All academic work must meet the standards contained in A
Culture of Honesty. Each student is responsible to inform themselves
about those standards before performing any academic work. A Culture of
Honesty is the University of Georgia's policy and procedures for handling
cases of suspected dishonesty and can be found online at www.uga.edu/ovpi . UGA
Student Honor Code states "I will be academically honest in all of my
academic work and will not tolerate academic dishonesty of others."
WebCT Quiz Policies and
Information
Missed Quizzes: You will have a
specific length of time to take an online quiz. Absences or failure to
turn in a quiz by the deadline will result in a failing grade for the
respective test unless there is a bona fide emergency involving the
student or an immediate family member. If such a case occurs, the student
must contact the UGA Regulatory Affairs Graduate Education Program
as soon as possible at (678) 407-5277 or email jhodges@rx.uga.edu.
WebCT Quiz Helpful Hints:
Quizzes will be posted on WebCT.
See WebCT quiz link for exact submission deadlines. In quiz view, you can
change the size of the frames if needed. Be sure to "Save Answer" for each
quiz question before submitting. Do not use browser's navigation buttons
while using the quiz module. If you lose your connection or close your
browser while taking a quiz, your "saved answers" will be saved until the
next time you open the quiz.
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