Have you Registered for the April 3-4 SBIA Generic Drug Forum (April 3-4)? PLUS Save the Dates for NEW SBIA Events

Only ONE Week Left Until the CDER SBIA 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

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

Avoid common errors related to the Drug Master File

And more…

Continuing Education Credits available via RAPS, SQA, and ACRP

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

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