Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Understanding and Appreciating the Regulatory Path for Diagnostic Tests and the Clinical Challenges in Sample Size and Design to Support Regulatory & Reimbursement Approvals

September 20-21, 2010
Baltimore, MD

About the Conference

As diagnostic tests become more complex, offering faster, more effective and targeted testing opportunities for physicians and patients, the challenges in assuring regulatory approval for these products increases in tandem. The diversity in the manner of test development and commercialization results in a difficult regulatory environment, and the rapid rate of new innovation has left the FDA and other regulators around the world challenged to keep pace with innovation. As regulatory agencies work to create new standards to assure the efficacy and safety of new diagnostic tests, they are increasing the amount and longevity of clinical research studies to support the utility and effectiveness of each new product. This conference program will bring together these regulators as well as industry experts who will share and discuss the challenges that they have faced in bringing new technologies to the market, as well as the strategies they have used to navigate through an uncertain regulatory environment.

Topics to Include

• Successfully Bringing a New Technology to Market from Early Development to Post-Market Surveillance
  
• Identifying Clinical Research Sites that Meet FDA Regulations
  
• Acquiring Suitable Sample Populations for Diagnostic Clinical Studies
  
• Gaining an FDA Perspective on Clinical Requirements for a 510(K)
  
• Overcoming Regulatory Obstacles in the Asian Market Prior to Commercialization
  
• Successfully Conducting a Pre-IDE Meeting to Minimize Regulatory Approval Time
  
• Distinguishing between Retrospective and Prospective Clinical Studies
  
• Ensuring Precise Data Collection during Diagnostic Clinical Trials
  
• Determining the Appropriate Intended Use when Designing Clinical Studies
  
• Overcoming Logistical Challenges when Conducting Diagnostic Clinical Studies
  
• Understanding and Following the Premarket Approval (PMA) Process from an FDA Perspective
  
• Developing Clinical Laboratory Improvement Amendment (CLIA) Waiver Tests
  
• Remaining Compliant with the Evolving FDA Clinical and Regulatory Regulations
  
• Designing Clinical Studies to Support Diagnostic Product Reimbursement
  
• Meeting Regulatory Requirements of the European Market
  
• Interpreting the FDA Guidelines for Molecular Diagnostics
  
• Companion Diagnostics: Bridging the Gap from the Early Development Process to Commercialization

FDA Speakers to Include:

Marina Kondratovich, Ph.D
Associate Director for Clinical Studies Personalized Medicine
OIVD, CDRH, FDA

Zivana Tezak, Ph.D
Associate Director for Science& Technology, Personalized Medicine
OIVD, CDRH, FDA

Carol Benson
Associate Director
OIVD, CDRH, FDA

Kathleen Whitaker, Ph.D
Scientific Reviewer, Division of Microbiology Devices

OIVD, CDRH, FDA

Kate Simon, Ph.D
Scientific Reviewer, Microbiology Division
OIVD, CDRH, FDA

To request the full two-day conference agenda, information on promotional pricing & registration details please contact:
Paul Hernandez, Marketing Manager
phernandez@Q1productions.com
312-602-9683