SBIA: Registration Open for the Generic Drugs Forum 2021: Lifecycle of a Generic Drug

FDA | CDER | Small Business and Industry Assistance CONFERENCES Generic Drugs Forum 2021: Lifecycle of a Generic Drug April 28-29, 2021 This conference is FREE. Registration and Agenda SELECTED AGENDA TOPICS Bioavailability/Bioequivalence Site Evaluation During the Pandemic Pre-ANDA Program Update and Tips for Success Learnings and Insight from Records Requests under § 704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections Mid-Review Cycle Meeting Overview Building a Better Sterility Assurance Application Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies And more... This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) review process. Presentations will focus on various aspects from pre-ANDA, drug development, post-marketing and global generic drug affairs program support for the generic drug program. KEYNOTE Sally Choe, Ph.D. Director, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER)  CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.  Certificates are only available during the two weeks post-event.  This course: has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion. has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant's RQAP re-registration. has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.  The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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