Webinar On FDA’s Expedited Programs for Serious Conditions – Drugs and Biologics
September 12, 2014 - Mississauga ON CACompliance Trainings
suzzane.d@compliancetrainings.com
Phone:4169154458
Description : This webinar will discuss four FDA programs intended to facilitate and expedite development, review and approval of new drugs to address unmet medical needs in the treatment of serious and life-threatening conditions. Areas Covered in the Session : FDA’s Expedited Program system Definitions for serious condition and unmet medical need FDA’s Breakthrough Therapy Designation Program FDA’s Fast Track Designation Program FDA’s Priority Review Designation Program FDA’s Accelerated Approval Program Who Will Benefit: Regulatory Affairs Personnel Quality Personnel Clinical Personnel Research Personnel Laboratory Personnel Manufacturing Personnel Legal Personnel Clinical Research Associates Personnel who require a general understanding of the FDA’s Expedited Programs for serious conditions Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299