Biotechnology and Basic Sciences

A to Z Course Index

Information Sessions

Certificate Programs

Transcripts

Course Locations

Concurrent Enrollment

Order a Catalog

Courses begin every month. A new edition of our catalog is published three times a year in early April, July and December.

Quick Enroll	Search

Understanding Medical Product Regulation

X451 (1 semester unit in Public Health)

A required course in the Professional Sequence in Biotechnology Business and Marketing

This course provides a broad overview of the regulation of medical products. Through a combination of lectures, discussions, and case studies, you learn about the regulations that guide the movement of medical products into major world marketplaces, as well as the issues that need to be addressed to expedite this process. Students learn about the history, content, and purposes of the U.S. Food, Drug, and Cosmetic Act; U.S. and international regulations and guidelines; and other guidance documents that provide for consumer protection in the marketing of drugs, medical devices, biologics, cosmetics, and dietary supplements.

You gain insight into the multilevel, overlapping jurisdictions of the regulatory bodies and into the roles of federal and foreign governments and international agencies. The meaning and significance of the common acronyms used in the field of regulatory affairs are presented, such as FDAMA, PDUFA, CFR, IND, NDA, IDE, PMA, 510(k), and cGMP, and the terms "safe and effective," "adulterated," and misbranded". This is a valuable course for anyone engaged in developing or marketing medical products in domestic or international markets.

There are currently no sections open for enrollment.

---

Sections closed for enrollment

Sat. Sept. 12, San Francisco

DONALD HOLSTEN, Pharm.D., is a senior regulatory affairs/quality assurance executive with more than 20 years of experience in food, drug, and cosmetic products. He has held senior management positions in industry and government agencies; produced numerous marketing applications for drugs, biologic products, and medical devices; and developed training programs in cGMP in the United States and abroad.

NOTE: This class is closed. For information about related courses, contact your academic department.

• $950 (EDP 411686)

Quick Enroll	Search