19007 Regulation of Drugs and Biologics

X400.009 NATSC

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Course Description:

Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course helps participants understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products.

Through lectures, case studies, and hands-on exercises, students gain knowledge and insight into the regulatory agencies and their roles and responsibilities; regulatory applications and pathways; post-marketing requirements; the impact of regulatory differences between U.S. and other countries; and how regulatory approval processes affect corporate strategy.

Prerequisite(s):

Completion of, or concurrent enrollment in "Drug Development Process" or equivalent experience.

Applies Towards the Following Certificate(s) & Award(s):

Certificate Program in Biotechnology

Certificate Program in Clinical Trials Design and Management

Certificate Program in Regulatory Affairs

Sections:

19007 - 011 Regulation of Drugs and Biologics

Status: Available

Section Note(s):Early Enrollment Fee: ($742.50 through Aug. 30).
(2 no meetings TBA).
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.

The books listed below are required for the "Regulation of Drugs and Biologics" course. These books will also be useful for other courses in the Regulatory Affairs Certificate Program, as well as for preparation for professional certification. These textbooks are available through the distributor at an educational discount. Details will be included on your enrollment receipt.
New Drug Development: A Regulatory Overview , 8th edition, Mark Mathieu, Paraxel International Corp., 2008, ISBN 1-882-61572-7
Fundamentals of US Regulatory Affairs , 6th edition, Regulatory Affairs Professionals Society (RAPS).

For Credit 3.0 Units
Mon 6:00PM to 9:00PM
Sep 13, 2010 to Nov 29, 2010
Number of Sessions: 10

Required Text(s): New Drug Development: A Regulatory Overview, 8th edition, Mark Mathieu, Paraxel International Corp., 2008, ISBN 1-882-61572-7; Fundamentals of US Regulatory Affairs, 6th edition, Regulatory Affairs Professionals Society (RAPS).

Recommended Text(s): None

Tuition:

$825.00

Method of Instruction: CLASSROOM
Campus: SANTA CLARA

Instructor(s):

SHELDON MULLINS, M.B.A.

19007 - 012 Regulation of Drugs and Biologics

Status: Available

Section Note(s):Early Enrollment Fee: ($742.50 through Mar. 21).
(no meeting May 30 and 2 no meetings TBA).
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.

The books listed below are required for the "Regulation of Drugs and Biologics" course. These books will also be useful for other courses in the Regulatory Affairs Certificate Program, as well as for preparation for professional certification. These textbooks are available through the distributor at an educational discount. Details will be included on your enrollment receipt.
New Drug Development: A Regulatory Overview , 8th edition, Mark Mathieu, Paraxel International Corp., 2008, ISBN 1-882-61572-7
Fundamentals of US Regulatory Affairs , 6th edition, Regulatory Affairs Professionals Society (RAPS).

For Credit 3.0 Units
Mon 6:00PM to 9:00PM
Apr 04, 2011 to Jun 27, 2011
Number of Sessions: 10

Recommended Text(s): None

Tuition:	$825.00
Early Enrollment	$742.50

Method of Instruction: CLASSROOM
Campus: SANTA CLARA

Instructor(s):

SHELDON MULLINS, M.B.A.