2014 - Webinar On FDA’s Expedited Programs for Serious Conditions ? Drugs and Biologics

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. This includes FDA’s newest expedited program Breakthrough Therapies Designation. Besides Breakthrough Therapies Designation also discuss will be Fast Track Designation, Accelerated Approval and Priority Review Designation. These programs are intended to help ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies benefits justify their risks. Criteria for each expedited program will be reviewed so a judgment can be made relative to your new drug. Also definitions for serious condition and unmet medical need will be covered.
A must attend webinar for those personnel that require an understanding of the FDA’s expedited programs for serious 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
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct,
Mississauga, ON L5V 2V5,
Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com