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7th Annual Device Research & Regulatory Conference - The Premier Conference for Device Professionals
May 9 and 10, 2013
(Optional Pre-Conference Workshop, May 8, 2013)
Chaparral Suites Scottsdale
5001 N. Scottsdale Road
Scottsdale, AZ 85250 USA
Phone: +1 (480) 949-1414
For Hotel Reservations, please contact the hotel or call 1 800 528 1456. Please mention SoCRA to receive the hotel room rate of $129 USD S/D (plus applicable taxes), available until April 8, 2013 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 18.4* Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this live activity for a maximum of 18.4* 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 14.3 credits (maximum). The Device Basics pre-conference workshop offers an additional 4.1 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 an introduction to the FDA’s regulatory framework for device research, FDA educational resources, a 510(k) update, IDE assessment information, a review of investigator responsibilities in device trials and recent FDA warning letters, as well as an overview of the device total product life cycle. Day 2 will include presentations on conducting device trials in ascending markets and how innovation can be a tool for growth and human factors engineering can benefit device research. Presenters will also discuss applicability of 21 CFR 812, MEDDEV 2.7.1, and ISO 14155 in device research, in-vitro diagnostic trials, biostatistics, and the IRB’s role in device research.
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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 recent FDA warning letters issued to sponsors, sites, and investigators
- Discuss issues related to 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 methodology used by industry and regulators to assure the quality and integrity of clinical research data
- Describe educational resources available from FDA’s Center for Devices and Radiological Health (CDRH)
- Describe the 510(k) program and recent program changes
- Discuss how device use and procedures impact investigational device exemption (IDE) application decisions
- Review current device GCP trends for PIs and identify common device GCP risks for investigator / sponsor studies
- Discuss relevant regulations and good clinical and regulatory practices to avoid issues identified in recent medical device warning letters
- Discuss the medical device total produce life cycle (TPLC) including IDEs, PMAs and GCP and compliance strategies
- Discuss topics of interest related to medical device research
- Identify factors for consideration when planning and conducting medical device studies in ascending markets
- Discuss factors to consider in launching a new clinical product, including intellectual property, science and access to markets
- Define human factors engineering (HFE) and describe how it aids in design and usability evaluation of medical devices
- Review US FDA regulations, European Commission guidelines, and international standards for conducting clinical trials on medical devices
- Identify factors to consider when designing and implementing in-vitro diagnostic (IVD) clinical trials
- Discuss the roles and responsibilities of the IRB in reviewing device research
- Describe the essential statistical elements required for a study protocol
- Discuss real-world issues 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* Note: If you experience difficulties, please use the PDF form.
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 May 2013 Conference Agenda in Adobe PDF format.
The 2014 Conference Agenda will be posted once it is available.
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