Date:
April 26 – 27, 2022
Day 1 :


HEY
Day 2:


HEY


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Agenda

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KEY STAKEHOLDERS

Sally Choe, Ph.D.
Director
Generic Medicines Office (OGD) | CDER | FDA

Michael Kopcha, Ph.D., R.Ph.

Michael Kopcha, Ph.D., R.Ph.
Director
Pharmaceutical Quality Office (OPQ) | CDER | FDA

ABOUT THIS EVENT

The Generic Drugs Forum (GDF) is an annual two-day virtual event that provides attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug review program. The purpose of the forum is to provide information to help potential and current applicants by offering practical advice, presenting case studies, and delving deeper into the Abbreviated New Drug Application (ANDA) review process.

This year’s theme is The current state of generic drugs and presentations will cover hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs.

TOPICS COVERED

  • Data integrity
  • Facility Assessment
  • FDA Pre-ANDA Program
  • Global generic drugs
  • Knowledge-Assisted Assessment and Structured Application (KASA)
  • Overview of ANDA program statistics
  • Pharmaceutical quality systems
  • Safety and post-market surveillance of generic drugs
  • Product Specific Guidelines for Generic Drug Development
  • Technical Considerations for Life Cycle Management of Pharmaceuticals

TARGETED AUDIENCE

The generic drug industry, consultants, regulatory affairs professionals or contractors, with an emphasis on those who:

  • are planning to submit an ANDA, are in the process of submitting an ANDA or have submitted an ANDA
  • involved in the development of generic drugs
  • work on generic drug bioequivalence, facility evaluation, stability, dissolution and impurity testing

FDA RESOURCES

  1. Product Specific Guidelines for Generic Drug Development
  2. Pharmaceutical Grade Resources
  3. Industry Resources
  4. Generic Drug Guidelines (under Subjects, choose “Generic Drugs”)
  5. Federal Generic Drug Registry Notices
  6. Generic Drug User Fee (GDUFA) Changes Science and Research

CONTINUOUS TRAINING

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

This course was:

  • pre-approved by RAPS as eligible for up to 12 credits for a two-day event (appropriate for real-time participation) toward a participant’s RAC recertification upon completion.
  • pre-approved by SOCRA which accepts documentation of the candidate’s participation in continuing education programs for recertification if the program is applicable to the regulations, operations or management of clinical research, or the therapeutic area of ​​clinical research of the candidate
  • pre-approved by the SQA as eligible for 1 non-GCP or non-GLP unit for each hour of instructional time toward a participant’s QPIP re-enrollment.
  • accredited by the ACRP for continuing education in clinical research. ACRP will provide 1 hour of ACRP contact for every 45-60 minutes of qualified material.

TECHNICAL INFORMATIONS

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