Compliance Trainings, Online
2015-08-11
This webinar will benefit formulation development, preclinical, clinical, and regulatory scientists in pharmaceutical companies and clinical research organizations (CRO) that are developing an indication for pediatric patients. Areas Covered in the Session : Review BPCA and PREA laws and changes under FDASIA Content of Pediatric Study Plans (PSP) FDA Review of PSP Compliance with PREA and BPCA Important links to relevant areas on FDA website Who Will Benefit: Project Managers Regulatory Specialists Clinical Scientists Pharmacokineticists Statisticians Product Development Scientists Product Development Manages Clinical Research Scientists Clinical Research Associates Writers who develop manuscripts for publication Independent physicians who serve as investigators for the study
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