sábado, 30 de marzo de 2019

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
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


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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