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  4. Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book - 10/27/2020 - 10/28/2020
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Virtual

Event Title
Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book
October 27 - 28, 2020

Scheduled

Date:
October 27 - 28, 2020
Day1:
- ET
Day2:
- ET

 

Agenda

Download Slides and View Recordings

 

 

ABOUT

In the first-ever Orange Book Conference, FDA will showcase the Orange Book and provide a roadmap for the rich information it contains. This conference is a great opportunity for the brand and generic drug industries, and other interested public health stakeholders, to hear from the agency’s Orange Book experts, and provide feedback on its use and functionality.

LEARNING OBJECTIVES

After this conference, participants will be able to…

  • Identify and use the various types of information in the Orange Book, including therapeutic equivalence ratings, patents, exclusivities, and more.
  • Describe the origin and history of the Orange Book.
  • List possible future Orange Book enhancements.

Topics

  • History of the Orange Book
  • Orange Book 101
  • Updates to Orange Book Information
  • Orange Book Content
  • Patent Information in the Orange Book
  • Best Practices for 505(b)(2) and ANDA Applicants
  • Exclusivity Information in the Orange Book
  • Therapeutic Equivalence

FDA KEYNOTE SPEAKER ADDRESS

The Future of the Orange Book

Sally Choe, PhD
Director
Office of Generic Drugs (OGD) | CDER | FDA

INTENDED AUDIENCE

  • Representatives of companies working on, and/or who hold approved ANDAs, and/or NDAs
  • Consultants serving above companies
  • Healthcare professionals and pharmacists who work with patients to select and identify therapeutic equivalents
  • Academics

FDA RESOURCES

Recent Orange Book publications include:

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • 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.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
  • This conference has been approved for continuing medical, pharmacy and nursing education units. Please see detailed announcement

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

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Event Materials

Title File Type/Size
Agenda_OBC_2020_pdf pdf (227.95 KB)
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