Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling 2012
13 Dec 2012
Webinar
Description
Topics
Reliability, Validity, and Sensitivity
PRO instruments: Conceptual framework, endpoint models
Protocol Considerations
Existing instruments, modified instruments, and newly created instruments. Types of evidence needed for FDA review
Multiple and Composite Endpoints
Electronic Data Capture
Interpretation of Clinical Trial Results
Statistical Considerations: SAPs
Who should Attend
Clinical Research Professionals
Pharmaceutical and Medical Device Company Representatives and Decision-Makers
Clinical Study Managers
Clinical Protocol Developers
Clinical Studies Directors
Regulatory Managers
Anyone seeking to design appropriate clinical investigations for supporting anticipated labeling for a new drug or medical device
Biostatisticians
Past Events
Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling 2012 - 13 Dec 2012, Webinar (34118)
Important
Please, check "Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling" official website for possible changes, before making any traveling arrangements
Event Categories
Education: Training
Health & Medicine: Medical device, Medical laboratories, Pharma
