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  5. Regulatory Education for Industry (RedI): 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019
  1. Development & Approval Process (Drugs)

Regulatory Education for Industry (RedI): 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019

Regulatory Education for Industry (RedI): 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019

Regulatory Education for Industry (RedI): 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019
Date and Time
September 25-26, 2019
Wednesday and Thursday
 
Location
The Hoteldisclaimer icon
7777 Baltimore Ave
College Park, Maryland 20740

About

As a continuation from the 2018 workshop on complex generic drug products, this science-focused workshop communicates to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA will link GDUFA science and research on complex products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science.

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You may attend in-person or virtually. This event is free.

Who should attend?

Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs.

Learning Objectives

After this course, participants will be able to:

  • Explain various mechanisms and processes that industry can use to obtain advice from the FDA to facilitate complex generic drug product development; and
  • Summarize new developments in science, guidance, and review experience for specific types of complex generic drug products.

Continuing Education Credit

  • This two-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • This event has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Attendance certificates are only available during the two weeks after the event. Attendance is required.