Announcing the FDA/CDER SBIA REdI Generic Drug Forum - April 3 & 4, 2019

FDA/CDER Small Business and Industry Assistance presents the

Regulatory Education for Industry (REdI) Generic Drug Forum

April 3-4, 2019

College Park MD

*  Registration, Agenda, and Conference Information *

Attend in-person or virtually

Registration is free

Advanced registration is required

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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.