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DEVICE Research - Regulations and Guidelines for DEVICE Clinical Research
May 20, and 21, 2009
Optional pre-conference DEVICE Basics Workshop to be held on May 19, 2009. Click here for more information.
The Avenue hotel Chicago
160 E. Huron Street
Chicago, IL 60611 USA
Phone: 312-787-2900
Reservations: 877-283-5110
SoCRA Hotel Rate: $199 S/D (US Funds), (plus applicable taxes) is available until the SoCRA room block is filled. |
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Registration Fees:
SoCRA member - $675 -
non-member - $750
Non-member fee includes membership for one year.
Preconference Workshop Fee: $175
Continuing Education Credit Hours:
SoCRA designates this educational activity for a maximum of 19.7* Continuing Education Credit Hours for SoCRA CE,
Nurse CNE, and Physician Category 1 CME.
*Device Basics - PreConference Workshop (Tuesday) maximum 4.2 CE
Device Regulations - 2 day Conference (Wednesday and Thursday) maximum 15.5 CE
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: 088-1-A-07
SoCRA Course Series: 900
The CCRP Certification Examination
is offered
throughout the year.
Your CCRP Certification Examination Registration
materials must be received
by the SoCRA administrative office six weeks prior to the exam date.
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Goal: This DEVICE RESEARCH conference for Clinical Research Professionals will introduce, explain and discuss fundamental concepts and current issues relating to compliance, human subject protection, research development and clinical investigation in the current regulatory environment. Speakers from academia, government (FDA), and industry will share their knowledge and expertise. You may also elect to participate in the half-day DEVICE BASICS workshop which will be held the day prior to the main program.
Objective: The main program will include experts involved in the research and development of safe and effective medical devices. Regulatory and compliance topics will include bioresearch monitoring (to include a case study); device regulations; computerized systems used in clinical investigations; US and EU testing requirements; IRB review and oversight of device research; Postmarketing surveillance; FDA inspections; IDE preparation as a Sponsor-Investigator; and the development of resources to promote compliance. Speakers will promote best practices through presentations regarding academia and industry collaborations; innovations; in-licensing; and protocol development.
Learning Objectives: Pre-Conference Workshop
The participant will be able to:
- Discuss the regulations that govern the administration of device clinical trials
- Describe roles and responsibilities, site selection/marketing, and human subject certification in device clinical trials
- Discuss budgeting and contracts from the perspectives of sponsors and sites
Learning Objectives: Conference
The participant will be able to:
- Discuss the regulations that govern device clinical trials
- Describe FDA inspection trends in device clinical research
- Discuss computerized systems used in clinical investigations
- Discuss device development successes (and failures) of academia and industry collaboration
- Describe how a clinical need is transformed into a product
- Describe means to avoid costly retest and redesign through knowledge of testing requirements (US and EU)
- Describe corporate processes for identifying, acquiring and integrating intellectual property
- Discuss regulatory and compliance trends as demonstrated through a case study
- Describe IRB review and oversight of medical device trials
- Discuss postmarket surveillance and its proper utilization
- Describe how to prepare an Investigational Device Exemption (IDE) application as a sponsor-investigator
- Discuss the trends regarding current findings of FDA audits
- Describe best approaches to protocol development
- Describe resources that can be used to promote regulatory compliance
- Discuss the impact of BIMO inspections on the regulatory review process at the clinical site
Learning Objectives: Optional Pre-conference Device Workshop The participant will be able to:
- Discuss the regulations that govern the management of device clinical trials
- Explain the monitoring process in device clinical research
- Discuss budgeting and contracts from the perspective of the sponsor and the site
This Pre-Conference Workshop is designed for those new to device clinical research or as a review of the device clinical research regulations and guidance. This half-day workshop will serve as a building block for the more advanced 2-day program which follows the workshop.
This will be a comprehensive overview for those interested in device clinical research and will include resources and tools that you can take home with you.
Please view the Conference Agenda for more information. Back to Top
Click
HERE to register online!*
Click Here to view/print the Conference Registration Form in Adobe PDF.
*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 $475 refund.
- 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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The Regulations and Guidelines for Device Clinical Trials and GCP 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 Conference Agenda in Adobe PDF format.
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