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  5. Regulatory Education for Industry (REdI): Generic Drug Forum April 3-4, 2019 - 04/03/2019 - 04/04/2019
  1. CDER Small Business & Industry Assistance (SBIA)

Education

Event Title
Regulatory Education for Industry (REdI): Generic Drug Forum April 3-4, 2019
April 03-04, 2019


Date:
April 03-04, 2019
Time:
12:00 AM - 12:00 AM EDT


Generic Drug Forum 2019
 
Date and Time
April 3- 4, 2019
Wednesday and Thursday
8:15-4:40
Location
The Hotel
7777 Baltimore Ave.
College Park, MD 20740

About This Event

This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications.

This event is free and available for in-person or via webcast.

Who should attend?

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

  • Plan to submit an ANDA or are in the process of submitting an ANDA
  • Involved in generic drug development
  • Work on bioequivalence, stability, dissolution and impurity testing
  • Submit Drug Master Files (DMFs)
  • Prepare regulatory submissions

After this course, attendees will be able to:

  • Discuss requirements for an ANDA
  • Understand and determine when to use a reference listed drug or a reference standard
  • Determine the types of FDA meetings and when to use controlled correspondence
  • Understand the factors resulting in an FDA refusal to receive decision
  • Identify common deficiencies in ANDAs including bioequivalence and quality (e.g. stability, dissolution and impurity testing)
  • Avoid common errors related to the Drug Master File (DMF)
  • And more…

Keynote Speakers

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

Michael Kopcha, PhD, RPh
Director
Office of Pharmaceutical Quality (OPQ) | CDER | FDA

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.
  • CME, CPE, and CNE will NOT be offered for this event.
  • Attendance certificates are only available during the two weeks after the event. Attendance is required.

Questions

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