Device Research Workshop 2012
May 16 - 18, 2012
Orlando FL , USA
Registration Fees:
SoCRA member - $675 - non-member - $750
Non-member fee includes membership for one year.
Preconference Workshop Fee: $175
oal: 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
SoCRA member - $675 - non-member - $750
Non-member fee includes membership for one year.
Preconference Workshop Fee: $175
oal: 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
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