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Agenda

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ABOUT THIS WEBINAR

In vitro studies that can support a demonstration of bioequivalence (BE) for topical generics typically include comparative physicochemical and structural (Q3) product characterization tests as well as in vitro release test (IVRT) and in vitro permeation test (IVPT) studies.

This webinar will provide an overview of comparative Q3 characterization as well as IVRT and IVPT studies for topical generic drug product development and common deficiencies FDA has encountered in these studies. This webinar will highlight best practices and resources that FDA has developed and made publicly available to help generic drug applicants successfully implement efficient in vitro characterization-based BE approaches for topical generic products.

There will be live question and answer sessions dedicated to each of three topic areas where audience can interact directly with FDA experts to help clarify questions and help generic drug applicants overcome challenges with developing topical generic products or preparing abbreviated new drug applications for these products.

LEARNING OBJECTIVES

• Explain the rationale and clarify practical considerations for conducting Q3 characterization tests for topical drug products submitted in ANDAs
• Explain the rationale and clarify practical considerations for conducting IVRT studies for topical drug products submitted in ANDAs
• Explain the rationale and clarify practical considerations for conducting IVPT studies for topical drug products submitted in ANDAs

INTENDED AUDIENCE

• Generic drug industry, including current and potential generic drugs applicants

FDA RESOURCES

• Product-Specific Guidances for Generic Drug Development
• FDA Drug Competition Action Plan
• Public Workshop: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course is:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• 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.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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