Since 2013, the Generic Drugs Forum has been a way for FDA to offer practical advice, provide case studies, and take a deeper dive into the Abbreviated New Drug Application (ANDA) assessment process.
This year's theme is The Current State of Generic Drugs and presentations will focus on hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs.
AUDIENCE
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
plan to submit, are in the process of submitting or have submitted an ANDA
are involved in generic drug development
work on generic drug bioequivalence, facility assessment, stability, dissolution and impurity testing
COST This conference is FREE.
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:
pre-approved by RAPS as eligible for a maximum of 12 credits (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion.
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.
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.
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.
This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.
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