Pharmaceutical Industry Practical Training Externship
COURSE DESCRIPTION
College Prefix: PHA
Course Number: 5625
Number of Credits: 2-6 hrs (variable); maximum 12 hrs
Course Coordinator/Instructor: College of Pharmacy Faculty members (advisors) in conjunction with
Industrial Scientists (liaisons) and
Corporations interested in training graduate and/or professional pharmacy
students in the pharmaceutical industry setting.
Daily meeting time: TBA
Semester: Summer C.
Class starts on the first day of summer semester and will end on the last day
of summer
semester of a given
year ( e.g. for FY 2005/2006: start May 9, 2005; end August 5th, 2005).
Pre‑requisites: Complete
one semester of the didactic graduate program in either Medicinal Chemistry,
Pharmaceutics, Pharmacodynamics or Pharmacy
Health Care or complete year of the
Professional (PharmD) curriculum.
Course
description:
This course is an "elective" experiential
training class that enables graduate students (M.S. and/or Ph.D.) from each of
the four graduate disciplines (Medicinal Chemistry, Pharmaceutics,
Pharmacodynamics and Pharmacy Health Care), and/or professional students
(Doctor of Pharmacy; PharmD) to obtain work
experience in a pharmaceutical industry setting. Students will spend 100% of
their time in an industry setting at locations to be determined by
college/industry contacts.
The course is designed
following a project‑based approach with the purpose of illustrating and
gaining practical experience in one or more of the various aspects of the
pharmaceutical industry. Specific industrial sectors that could be considered
would be: drug discovery, formulation and development, pre-clinical and
clinical trials, investigational new drug (IND) and new drug application (NDA)
processes, regulatory affairs, product formulation, product marketing,
post-marketing product surveillance and industrial intra- and inter-relations.
The student will be required to read appropriate journals, books, monographs,
etc. to be knowledgeable in the area(s) assigned during their training externship.
The site for the student's
practicum and the
Ability Based Outcomes:
1. The student should be able
to describe, discuss and contribute to the process of research or drug
development and regulation in the pharmaceutical industry.
2. The student should be able
to describe, analyze, conduct and present research findings related to a
specific project in the pharmaceutical industry.
Grading:
Grading will be based on the
S/U format. Each student must have satisfactory attendance, enthusiasm for
completion of projects, turn in assignments on time, make a verbal and/or
written presentation on an assigned topic, and complete and turn in a journal of
activities during the externship. Product confidentiality issues shall be
considered during preparation of the student's journal.
List of Potential Topics for Experiential Training:
1. New drug research and
development (Drug Discovery)
·
Organic Synthesis
·
Biotechnological Approaches
·
Computer modeling
2. Pre-clinical testing
·
Chemistry/Biological Properties
·
Efficacy/Pharmacology/Toxicology
·
Drug Delivery
·
Preformulation and Pharmaceutics
·
Dosage Forms Development
3. Clinical trials
·
Phase I
·
Phase II
·
Phase III
4. Manufacturing
·
Scale-up
·
Packaging
·
Post-approval Changes
5. Investigational new drug
(IND) and new drug application (NDA) processes (Regulatory Affairs).
·
Submission
·
FDA Review and Action
·
Site Inspection
·
GLP/GMP/GCP compliance
·
Product Labeling
6. Product marketing
·
Sales
·
Advertising
7. Post-marketing product
surveillance
·
Phase IV Clinical Trials
·
Pharmacoeconomics
·
Adverse Drug Reactions
·
Product Line Extension
8. Industrial intra- and
inter-relations.
·
Patenting and Licensing
·
Market interactions