FDA

FDA Clinical Trial Requirements Regulations, Compliance, and GCP Conference

Dates, Location, Contact Information and Fees Conference Description Learning Objectives Conference Agendas Online Registration Form (Credit Card) Conference Registration Form (PDF)

Dates, Location, Contact Information, Fees, and SoCRA Program Chairpersons

May 21 and 22, 2008 Radisson Hotel Boston 200 Stuart Street Boston, MA 02116 Phone: 617.482.1800 Fax: 617.451.2750 SoCRA’s reduced room rate of $179 USD plus taxes is available until four weeks before the conference or until the room block is filled. 08702
November 19 and 20, 2008 Westin Crown Center 1 East Pershing Road Kansas City, MO 64118 Phone: 816.474.4400 Fax: 816.391.4438 SoCRA’s reduced room rate of $129 USD plus taxes is available until four weeks before the conference or until the room block is filled. 08703

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Fees

• $575 Member Fee (Standard Rate)
• $650 Non-Member Fee (Standard Rate)
• $450 Member Fee (Federal Government Employee only)
• $525 Non-Member Fee (Federal Government Employee only)

Fee Waived for FDA Employees only.

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Conference Description

SoCRA is pleased to announce this conference that is jointly sponsored with District/Regional offices of the U.S. Food and Drug Administration.

This conference on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives.

This two-day conference is intended to share information among FDA representatives and the regulated community, to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience.

The program will focus on the relationships among the FDA and clinical trial staff, investigators and IRBs. The workshop will highlight three areas that present challenges to sponsors and investigational sites: FDA Clinical Research Requirements, Enhancing Success through Communication and Financial Incentives, and Assuring Confidence in Clinical Research.

Continuing Education Credit Hours
SoCRA designates this educational activity for a maximum of 13.25 Continuing Education Credit Hours for SoCRA CE, Nurse CNE, and Physician Category 1 CME.

Accreditation Statements:

• CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
• CNE for Nurses: This continuing nursing education activity was approved by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.

ANCC/PSNA Provider Reference Number: 075-1-A-07

SoCRA Course Series: 700

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Learning Objectives

Upon completion of the conference, the attendee should be able to:

• Discuss the Role of the FDA District Offices, how they are Structured and their Responsibilities
• Describe what FDA Expects in a Pharmaceutical Clinical Trial
• Discuss the Science, Regulation and Assessment of Adverse Events
• Discuss how Studies with Investigational Devices differ from those with Drugs and Biologics
• Describe the Regulations that Apply to the Informed Consent Process
• Discuss how the Ethical Principle of Justice underlies Responsible Participant Selection
• Describe the IRB Regulations and FDA’s Mechanisms to Assure Compliance
• Describe the Parameters included in Regulations Applying to Electronic Signatures
• Describe how the FDA Small Business Representatives assist the Research Community
• Discuss the Responsibilities of the Clinical Investigator
• Describe how Pre-IND Meetings and the FDA Meeting Process assist the Research Goal
• Describe the Sponsor/Investigator’s Legal Responsibilities, Additional Duties and Concerns
• Describe how the FDA’s Center for Biologics Regulates Research
• Discuss the Array of Actions taken when Research Fails to Meet Standards Enforced by the FDA
• Describe how the FDA’s Center for Food Safety and Applied Nutrition Regulates Research on Food Additives
• Describe how the FDA’s Office of Science and Health Coordination, Good Clinical Practice Program, Promotes Confidence in Clinical Research

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Conference Agenda

The Conference Agenda is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software.)

Click Here to view/print the February 2008 Conference Agenda in Adobe PDF format.

Click Here to view/print the May 2008 Conference Agenda in Adobe PDF format.

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Online Registration Form (Credit Card)

Click HERE to register online!

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Conference Registration Form

The Conference Registration Form is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software.)

Click Here to view/print the Conference Registration Form in Adobe PDF format.

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