Horsham, PA (Vocus) August 27, 2009
Progression-Free Survival (PFS) endpoints are increasingly used for evaluation and approval of oncology drugs. Representatives from FDA, the National Cancer Institute (NCI), and PhRMA will present their perspectives on clinical, radiological, and statistical evaluation of progression-free survival. Sessions will include:
- Clinical Assessment of Progression-Free Survival (PFS)
- Radiological Evaluation of Progression-Free Survival (PFS)
- Criteria for Determination of Progression
- Statistical Evaluation of Progression-Free Survival- Role and Design of Independent Review
- Statistical Evaluation of Progression-Free Survival--Handling Missing/Censored Observations
- Statistical Evaluation of Progression-Free Survival--Analysis of Progression-Free Survival
- Regulatory Considerations
Richard Pazdur, MD, Director, Office of Oncology Drug Products, CDER, FDA, will deliver the keynote address. In addition to his experience as a regulatory expert at FDA, Dr. Pazdur has distinguished himself in clinical and academic oncology. Click here for complete bio.
In addition, two tutorials will be held on October 7:
- Time to Event Analysis for Non-Statisticians
- Statistical Methods for Interval Censored Data Analyses
Click here to register for the Progression-Free Survival Oncology Workshop.
About the Drug Information Association (DIA):
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.