FDA Clinical Trial Requirements
Regulations, Compliance, and GCP
May 15 and 16, 2013
Renaissance Seattle Hotel
515 Madison Street
Seattle WA, 98104
Hotel phone: 206 583 0300
Reservations: 800 266 9432
SoCRA’s hotel room rate of $159 S/D USD (plus applicable taxes) is available until April 23, 2013 or until the SoCRA room block is filled.
November 6 and 7, 2013
JW Marriott Atlanta Buckhead
3300 Lenox Road NE
Atlanta GA, 30326-1333
Hotel phone: 404 262 3344
Reservations: 800 228 9290
SoCRA’s hotel room rate of $185 S/D USD (plus applicable taxes) is available until October 15, 2013 or until the SoCRA room block is filled.
- Standard Rate - Member Fee - $575
- Standard Rate - Non-Member Fee *- $650
- Federal Government Employee Rate - Member Fee - $450
- Federal Government Employee Rate - Non-Member Fee*- $525
- FDA Employee Rate - FEE WAIVED
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA
Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 13.3 Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 13.3 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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: Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 205-3-A-09
SoCRA Course Series: 700
Goal: 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.
Objective: 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.
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 Office of Science and Health Coordination, Good Clinical Practice Program, Promotes Confidence in Clinical Research
Click HERE to Register Online* Note: If you experience difficulties, please use the PDF form.
Click Here to view/print the Conference Registration Form in Adobe PDF format.
*SoCRA REGISTRATION POLICIES/INFORMATION:
- Non member fees include a one year membership in SoCRA.
- Membership fees are processed immediately and are not refundable.
Fees are in U.S. dollars.
- Please make checks payable to “SoCRA”
- Checks must be drawn on a U.S. bank or marked “Pay in U.S. Funds”.
- Written cancellation requests received by SoCRA at least 10 business days prior to start of course may receive a $400 refund ($315 refund Federal Gov’t Employee).
- We regret that refunds cannot be issued for cancellations on or after 10 business days prior to start of course.
- Taping (audio or video) is prohibited unless SoCRA’s written permission has been acquired.
- ADA - This program is accessible to persons with disabilities. Please list any special needs in the area indicated in the registration form.
- If for any reason this conference cannot be held, SoCRA is not responsible for costs incurred by attendees, such as airfares, or hotel or other reservations.
- SoCRA is an educational non-profit membership organization (corporation) - Federal Tax ID #61 1208981.
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Click Here to View/Print the Conference Agenda in Adobe PDF format.
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