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
This conference has been approved for 12.75 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. Each day after the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim codes.
This course is:
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.
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