- April 03-04, 2019
12:00 AM - 12:00 AM EDT
Wednesday and Thursday
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…
Sally Choe, PhD
Office of Generic Drugs (OGD) | CDER | FDA
Michael Kopcha, PhD, RPh
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.
Please contact firstname.lastname@example.org for all technical questions.