Title: Webinar On FDA’s Expedited Programs for Serious Conditions – Drugs and Biologics
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FDAs Expedited Programs for Serious Conditions -
Drugs and Biologics Friday, September 12, 2014
1000 AM PDT 0100 PM EDT Duration 120
Minutes Register Now
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 FDAs
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.
Instructor
Albert A. Ghignone
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
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2process for drugs, biologics, medical
A must attend webinar for those personnel that
require an understanding of the FDAs expedited
programs for serious conditions.
devices and generic drugs. He has worked in every
major segment of the industry-research, quality
assurance, regulatory affairs, manufacturing and
clinical. He lectures throughout the world on
numerous FDA related matters. He is a consultant
to FDA and trains FDA Field Force (those who
conduct FDA inspections) on GCP, GLP and GMP). In
recent years he has filed numerous FDA drug,
biologic and medical device submissions for
product approval.
Areas Covered in the Session
FDAs Expedited Program system Definitions for
serious condition and unmet medical need FDAs
Breakthrough Therapy Designation Program FDAs
Fast Track Designation Program FDAs Priority
Review Designation Program FDAs Accelerated
Approval Program
Who Will Benefit Upcoming Webinars
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 FDAs Expedited Programs for
serious conditions
Quality by Design (QbD) Across the Product
Lifecycle
How to Implement HIPAA Requirements in GxP
Regulated Establishments
Risk Management Principles
FDA Adverse Event Reporting for
Drugs and Medical Devices Available Recorded
Webinars Register Now Root Cause Analysis and
Corrective Action Good Laboratory Practice
Regulations
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