Albert A. Ghignone
Instructor Albert A. Ghignone
Product Id 601119
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

FDA's New Breakthrough Therapy Designation Program and Other FDA Expedited Programs


This webinar will discuss four FDA expedited 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 webinar includes FDA's newest expedited program Breakthrough Therapy Designation. Besides Breakthrough Therapy 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 and life-threatening conditions are approved and available to patients as soon as it can be concluded that the therapy's 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, unmet medical need and other definitions will be covered.

Why should you attend: This web presentation is intended for those professionals that require knowledge about FDA's New Breakthrough Designation Program and the Other FDA Expedited Programs.

  • Regulatory Affairs Personnel
  • Quality Personnel
  • Research Personnel
  • Clinical Personnel
  • Manufacturing Personnel
  • Auditors
  • Clinical Research Associates (Monitors)
  • Legal Personnel

Areas Covered in the Session:
  • FDA's four expedited programs for serious and life-threatening conditions.
  • Criteria for Breakthrough Therapy Designation
  • Criteria for Fast Track Designation
  • Criteria for Priority Review Designation
  • Criteria for Accelerated Approval
  • Definitions for each expedited program
  • Process for each expedited program

Who Will Benefit:
  • Regulatory Affairs Personnel
  • Quality Personnel
  • Research Personnel
  • Clinical Personnel
  • Manufacturing Personnel
  • Legal Personnel
  • Personnel who require an understanding of FDA's expedited programs

Speaker Profile
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. 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 addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.

In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.

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