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DEVICE Research - Regulations and Guidelines for DEVICE Clinical Research
May 19 and 20, 2011
Bally’s Las Vegas
3645 Las Vegas Blvd South
Las Vegas, NV 89109
Phone: +1 (877) 603 4390
For Hotel Reservations, please contact the hotel or call 1 (800) 358 8777. Please mention SoCRA to receive the hotel room rate of $99 USD (plus applicable taxes), available until May 3, 2011 or until the SoCRA room block is filled. |
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SoCRA Educational Opportunities Calendar
for the latest dates! |
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* Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this educational activity for a maximum of 19* AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.
* The Device Regulations Conference offers 15 credits (maximum). The Device Basics pre-conference workshop offers an additional 4 credits (maximum).
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: 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: 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, research development and clinical investigation in the current regulatory environment. Speakers from academia, government (FDA), consultants 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. Topics will include: Bioresearch Monitoring (to include a case study); European Regulatory Requirements for Clinical Studies, Comparative Effectiveness Research, Human Factors, Postmarket Surveillance, IRB Review of Medical Device Studies, and Data Integrity. Speakers will also promote best practice through presentations regarding Device Billing Compliance, Cost Drivers of Device Studies, Clinical Validation, Study Coordinator Best Practice and Clinical Consultant in Clinical Research.
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
- Describe the monitoring process in device clinical research
Learning Objectives: Conference
The participant will be able to:
- Discuss issues related to the conduct of device clinical research
- Describe how the FDA views compliance and enforcement matters
- Discuss the impact of comparative effectiveness research (CER) on the medical device industry in the United States and abroad
- Describe European Union regulations, standards and guidance documents concerning EU clinical trials
- Discuss the importance of good data collection at the site and how this impacts the statistical analysis
- Discuss how the design controls process can provide evidence of assessed user-device interaction safety issues
- Describe research billing compliance, current regulatory policies related to billing, tips for distinguishing between standard of care and research procedures, and other financial issues related to medical devices
- Discuss CDRH BIMO inspections and their impact on regulatory review
- Describe the FDA’s authority to require postmarket surveillance studies for certain medical devices and the agency’s implementation of this authority
- Discuss the elements of device product development, the significant drivers of cost, and ways to minimize costs
- Discuss international protocols that have been developed to clarify requirements for studies involving blood pressure monitors
- Describe IRB process for reviewing new research proposals involving FDA regulated devices; the information the IRB needs in order to make required determinations; and what level of review is required for different types of studies
- Describe how creating an effective communication process in your team can create positive results
- Discuss best practices by monitors when working with study coordinators and clinical consultants in the conduct of clinical research
- Discuss the advantages and disadvantages of using clinical consultants versus an outside CRO
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.)
2011 Agenda coming soon.Click Here to view/print the 2010 Conference Agenda in Adobe PDF format.
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