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DEVICE Research - Regulations and Guidelines for DEVICE Clinical Research
May 16 to 18, 2012
The Wyndham Lake Buena Vista Resort
1850 Hotel Plaza Boulevard
Lake Buena Vista, FL 32830
Phone: 407-828-4444
For Hotel Reservations, please contact the hotel or call 800-624-4109. Please mention SoCRA to receive the hotel room rate of $95 USD (plus applicable taxes), available until April 16, 2012 or 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 18* Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 18* AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
* The Device Regulations Conference offers 14 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 concepts and current issues relating to compliance, research development and clinical investigation in the current regulatory environment. Those new to device research may also elect to participate in the half-day DEVICE BASICS workshop which will be held the afternoon prior to the main 2-day program.
Objective: This 2-day advanced conference will include experts involved in the research and development of safe and effective medical devices. Day 1 includes a 510(k) Update, PMA Submission Strategy a PMA Case Study from FDA experts as well as speakers discussing Evaluating Effectiveness, FDA Perspective on IVD, IRB Roles and Responsibilities and ISO 14155. Day 2 will include presentations from innovation, communication and human factors experts. Presenters will also discuss process methods to integrate clinical trials into your design process, review risk management for devices, device monitoring and reporting device-related adverse events and effects.
Learning Objectives: Pre-Conference Workshop
The participant will be able to:
- Discuss the regulations that govern the administration of device research including risk categorization and device classifications
- Discuss site selection, study monitoring and management
- Discuss fundamental CDRH BIMO IRB inspections
- Review the basic concepts related to medical device research
Learning Objectives: Conference
The participant will be able to:
- Discuss issues related to the conduct of device clinical research
- Describe 510(k) changes to existing 510(k) program
- Discuss development of a PMA submission strategy
- Discuss considerations for for conducting perspective, retrospective, post-market and registry trials to support effectiveness.
- Discuss FDA’s perspective on In Vitro diagnostic devices
- Discuss the roles and responsibilities of the IRB in device research
- Understand what is required to be ISO 14155 compliant
- Review a case study which highlights the PMA review process
- Discuss innovation in regard to human factors
- Discuss communication from the research perspective
- Discuss and review both the conduct of usability research methods
- Review integration of clinical trials into the design process
- Review the process for assessing device risk
- Discuss special considerations for device monitoring
- Review and understand device-related adverse events and device effects occurring during a clinical trial
- Discuss topics of interest related to medical device research
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 2012 Conference Agenda in Adobe PDF format.
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