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Agenda

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ABOUT THIS EVENT

The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), GDUFA III updates, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA, and ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development.

INTENDED AUDIENCE

• Scientists, researchers, current and prospective generic drug applicants
• Regulatory affairs professionals who work on or have an interest in the development of generic drugs, including complex generic products.

TOPICS COVERED

Generic product approval and supporting research, featuring:

• Products with complex active pharmaceutical ingredients (APIs)
• Complex injectable product
• Topical drug products
• Ophthalmic emulsion products
• Orally inhaled drug products
• Noteworthy guidance development and updates
• New process/research/assessment tools to support generic product development and post-market surveillance
• Global collaboration to support efficient generic product development and regulatory assessment

LEARNING OBJECTIVES

• Comprehend new developments in science, guidance, and regulatory assessment experience for generic drug products
• Keep up to date on GDUFA III enhancements and changes
• Understand FDA’s perspectives, research, and regulatory assessment relating to generic drug development
• Apply various mechanisms and methodologies that drug developers can use to facilitate generic drug development

FDA RESOURCES

• GDUFA Science and Research
• Generic Drug Development
• GDUFA III Reauthorization
• Pre_ANDA Program
• Product-Specific Guidances for Generic Drug Development
• Guidances Related to Generic Drugs

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 has been 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.
• 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.
• 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.
• 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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