Webinar On FDA’s Expedited Programs for Serious Conditions – Drugs and Biologics

Compliance Trainings, Canada
2014-09-12

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@compliancetrainings.com

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.

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