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Pharmaceutical Development and Regulation

Release Date: October 21, 2008
Expiration Date: October 21, 2010


TARGET AUDIENCE
This educational activity is intended for healthcare professionals who engage in medication prescribing practices in the U.S.

EDUCATIONAL OBJECTIVES
Upon completion of this activity, participants should be able to: Describe key steps in the pharmaceutical approval process; Outline key laws and regulations impacting pharmaceutical development; Recognize the differences between generic and branded drug development; and Explain patents, exclusivity, and intellectual property.

ESTIMATED TIME TO COMPLETE EDUCATIONAL ACTIVITY
The activity will take approximately 25 minutes to complete.

CREDIT DESIGNATION
The University of Texas Southwestern Medical Center designates this educational activity for a maximum of .5 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

ACCREDITATION STATEMENT
This activity has been planned and implemented in accordance with the Essential Areas & Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of The University of Texas Southwestern Medical Center and the Federation of State Medical Board's Research and Education Foundation. The University of Texas Southwestern Medical Center is accredited by the ACCME to provide continuing medical education for physicians.

FACULTY INFORMATION
Course Director
James N. Thompson, M.D.
Federation of State Medical Boards Research and Education Foundation, Secretary
Federation of State Medical Boards, President and Chief Executive Officer
Dallas, Texas

Module Directors
Jerry H. Gurwitz, MD
Professor of Medicine
Director, Meyers Primary Care Institute
Chief, Division of Geriatric Medicine
University of Massachusetts Medical School
Worcester, MA

Melissa A. Fischer, MD, MEd
Assistant Professor of Medicine
Director, Internal Medicine Clerkship
University of Massachusetts Medical School
Worcester, MA

METHOD OF PARTICIPATION
To receive CME credit, you must:

  • Review the full content of the activity.
  • Successfully complete the post-test (70% or higher) and evaluation.
  • You will have 3 opportunities to successfully complete the activity.

Your statement of credit will be issued immediately upon successful completion of the post-test and submission of the evaluation form.

FEE
This activity is provided at no cost to the physician through a grant to the Federation of State Medical Boards from the Attorney General Consumer and Prescriber Education Grant Program.

COMMERCIAL SUPPORT
None.

FINANCIAL RELATIONSHIP INFORMATION

Faculty Type or Relationship/Name of Commercial Interest(s)
Jerry H. Gurwitz, MD None
Melissa A. Fischer, MD, MEd None
Michael Tutty, MHA None
Jennifer L. Donovan, PharmD Speaker/Sanofi-Aventis
Becky A. Briesacher, PhD Contracted Research/Novartis
Thomas McLaughlin, ScD None
James N. Thompson, M.D. None

OTHER DISCLOSURES
The following presentation contains some items that are covered by copyright and are used under Fair Use for education and the federally legislated TEACH Act. Any use for other purposes must follow U.S. copyright rules.

The contents of this module are accurate at the time of publication.

This work was made possible by a grant from the states Attorneys General Consumer and Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

We would also like to thank all of those who contributed time and effort to this project, including faculty and staff of: University of Massachusetts Medical School, Fallon Community Health Plan, Fallon Clinic, University of Massachusetts Graduate School of Nursing, Massachusetts College of Pharmacy and Health Sciences, MassHealth, and the Meyers Primary Care Institute.

SOFTWARE REQUIREMENTS
PC
Microsoft Windows 2000 SE or above.
Internet Explorer (v5.5 or greater), or Firefox
Adobe Acrobat Reader*

MAC
MAC OS 10.2.8
Safari
Adobe Acrobat Reader*
Internet Explorer is not supported on the Macintosh.

* Required to view printable (PDF) version of the lesson.

 


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