Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.
This week we hear from Dr. Susan Trieu, who in her 12+ years in the industry has worked in regulatory affairs. Since then, Dr. Trieu has gone on to work in Industry at MedImpact as their Drug Information Pharmacist.
Clinical Study & Start-up Activities, Joseph Ma, Pharm.D.
This module is presented by Dr. Joseph Ma, Associate Professor in the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences.
Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.
This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer.
Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.
Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer
Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.
New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.