Course Description:

Registry is an important component of clinical research. It is one of the most reliable approaches for the evaluation of disease progression, clinical outcomes of a medical intervention, diagnosis and treatment patterns, and safety surveillance of a medical product, in a non-interventional and real world setting. A registry could be disease specific, intervention specific, or time and setting specific. Registry of a newly marketed medical product, device or drug, is most likely required by the regulatory agency to ensure the safety and effectiveness of the product in broader patient population than in pre-marketing testing. The datasets created from a registry provides insight to government, manufacture, and clinicians on healthy policy, business strategy and medical decision. This course is to provide audience an overview on definition, methodology, and implication of various types of registries through case studies with real life landmark registries that were conducted in China and other countries. This course will also introduce the China Chronic Disease Registries organized by Chinese Medical Doctor Association.

Who should attend?

• Science and business leaders of manufactures (medical device, pharmaceuticals, other health care products)
• Clinicians and clinical research investigators
• Hospital administrators and quality assurance department
• Hospital IT department
• Academic clinical researcher
• Leaders of contract research organization
• Data miner, data manager, and biostatisticians of clinical research organization
• Policy makers for government agency

 What will one learn?

 After attending the workshop, the participants are expected to learn:

• For industry: How and when to conduct a registry in order to better understand its own product as well as clinical dynamics;
• For clinicians: The roles and responsibilities for participating in a registry as an investigator, how to initiate a disease registry, and how to integrate the results gained from a registry into other medical evidence;
• For academia: How to better interpret and synthesize registry datasets
• For government: FDA initiatives on international registries

Course Instructors:

Danica Marinac-Dabic, MD, PhD, Director, Division of Epidemiology
Office of Surveillance and Biometrics, Center for Devices and Radiological Health,  US Food and Drug Administration



 Art Sedrakyan, MD, PhD, Director, Patient-Centered Comparative   Effectiveness Program, Weill Cornell Medical College and New York Presbyterian Hospital


Danyi Zhang, MD,
President and Chief Medical Officer
VitalStrategic Research Institute

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