FDA/CDER Small Business and Industry Assistance presents the
Regulatory Education for Industry (REdI) Generic Drug Forum
April 3-4, 2019
College Park MD
Attend in-person or virtually
Registration is free
Advanced registration is required
* * * * *
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.
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
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…
Continuing Education Credit
- Pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- 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.
- Attendance is required for attendance certificates which are only available during the two weeks after the event.
- 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.
Meeting Materials
- Slides will be available for download on the day of the event.
Webcast Information
- Upon registration, you will receive an acknowledgement email which will provide the webcast link. This link will be activated on the days of the event.
Questions
- Please contact info@sbiaevents.com for all technical questions.
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