- April 28 - 29, 2021
8:00 AM - 4:00 PM ET
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This conference is FREE and part of the SBIA Regulatory Education for Industry (REdI) series.
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.
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
- plan to submit an ANDA or are in the process of submitting an ANDA
- involved in generic drug development
- work on bioequivalence, stability, dissolution and impurity testing
- prepare regulatory submissions
- Product-Specific Guidances for Generic Drug Development
- Industry Resources
- GDUFA Science and Research
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.
- 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.
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