UNDATED – This public workshop will provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
FDA will take the information it obtains from the public workshop into account in developing its FY 2022 GDUFA Science and Research Priority Initiatives.
The free workshop will be held on July 23, 2021.
To register click here.
BREAKOUT SESSIONS
The workshop will include interactive breakout sessions on the following topics:
- Model-Integrated Evidence for Generic Drug Development
- Complex Product Characterization and Analysis
- In Vitro and In Vivo Bioequivalence Approaches: Challenges and Opportunities
AUDIENCE
Generic drug industry stakeholders including scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs.
WE WANT TO HEAR FROM YOU
FDA seeks suggestions for generic drug research topics from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties. Submit your potential topics and suggestions for the FY 2022 GDUFA Science and Research Priorities to the public docket number FDA-2017-N-6644.
When registering for the event you may indicate which breakout session you would like to attend.
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.
