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Required courses:
RA
601. The Pharmaceutical, Biotechnology, and Medical Device Industries
(3 units)
Prerequisite: Chemistry 361A or 365
Introduction to the pharmaceutical, biotechnology and medical device
industries. General overview of company organization and product
development and commercialization associated activities, e.g., drug
discovery, chemical synthesis, quality assurance, regulatory affairs,
manufacturing, control and marketing.
RA
602. Introduction to Food and Drug Law (3 units)
Prerequisite: To be taken either concurrently with or following
RA 601
Introduction to laws governing drug, biological and medical device
products. Discussion of Federal Food, Drug & Cosmetic Act, US
Public Health Service Act, Title 21 Code of Federal Regulations,
and various amendments.
*STUDENT MUST PURCHASE
TEXT*
RA
770. Current Good Manufacturing Practice - General Concepts (3 units)
Prerequisite: Regulatory Affairs 602
Study of current Good Manufacturing Practice regulations to assure
quality of marketed products. Application to manufacturer’s
organization, personnel, facilities, equipment, control systems,
production, process controls, laboratory procedures and records.
Students who start the Advanced Certificate program before August 1, 2006 must choose one
elective course from the following:
RA
705. Project Planning for the Biomedical Industry (3 units)
Prerequisite: Regulatory Affairs 602 or Consent of the Instructor
This online course provides an introduction to project planning
and coordination using pharmaceutical research & development
as a pertinent example of the use of Microsoft Project software.
This course may be taken by MS in RA students as an alternate to
IDS 750.
RA
772. Post-Approval Activities, Including FDA Advertising, Promotion
and Labeling (3 units)
Prerequisite: Regulatory Affairs 602
FDA and FTC rules and regulations governing advertising, promotion,
and labeling for prescription drugs, biologics, medical devices,
and over-the-counter drugs.
RA
774. Investigational and Marketing Applications for Drugs, Biologics,
and Medical Devices (3 units)
Prerequisite: Regulatory Affairs 602
Examination of the development and informational content for: investigational
new drug applications (IND), investigational device exemptions (IDE),
new drug applications (NDA), product license application (PLA),
and biologics license applications (BLA) for FDA review.
RA
779. International Medical Regulations (3 units)
Prerequisite: Regulatory Affairs 602
This course will explore international medical regulations in their
current status in many of the key areas of the world today. It also
will contribute to an understanding of the changes brought about
by multi-national projects due to cultural differences.
*STUDENT MUST PURCHASE TEXTS*
RA 781 - PRACTICAL ETHICS FOR HEALTHCARE PROFESSIONALS (3)
Prerequisite: Regulatory Affairs 602
Ethical issues confronting healthcare professionals. Moral positions concerning impact on laboratory animals, human subjects, patients and consumers, both on a case-specific level and as applied to the field in general. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice.
Students who start the Advanced Certificate program after August 1, 2006 must take the following required course:
RA 781 - PRACTICAL ETHICS FOR HEALTHCARE PROFESSIONALS (3)
Prerequisite: Regulatory Affairs 602
Ethical issues confronting healthcare professionals. Moral positions concerning impact on laboratory animals, human subjects, patients and consumers, both on a case-specific level and as applied to the field in general. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice.
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