UNDATED – This public workshop will present an outline of the standing of present science and analysis initiatives for generic medication and a possibility for public enter on these initiatives.
FDA will take the knowledge it obtains from the general public workshop into consideration in creating its FY 2022 GDUFA Science and Analysis Precedence Initiatives.
The free workshop shall be held on July 23, 2021.
To register click here.
The workshop will embrace interactive breakout periods on the next subjects:
- Mannequin-Built-in Proof for Generic Drug Improvement
- Complicated Product Characterization and Evaluation
- In Vitro and In Vivo Bioequivalence Approaches: Challenges and Alternatives
Generic drug business stakeholders together with scientists/researchers, clinicians, regulatory affairs professionals, and affected person advocates who work on or are fascinated about analysis that advances the event of generic medication.
WE WANT TO HEAR FROM YOU
FDA seeks options for generic drug analysis subjects from a wide range of stakeholders––business, academia, affected person advocates, skilled societies, and different events. Submit your potential subjects and options for the FY 2022 GDUFA Science and Analysis Priorities to the general public docket quantity FDA-2017-N-6644.
When registering for the event chances are you’ll point out which breakout session you want to attend.
Actual-time attendance is required for the certificates of attendance which can be utilized in help of CEs for the next skilled organizations. Certificates are solely accessible through the two weeks post-event.
- has been pre-approved by RAPS as eligible for credit (acceptable to real-time attendance) in the direction of a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in persevering with teaching programs for re-certification if this system is relevant to medical analysis laws, operations or administration, or to the candidate’s medical analysis therapeutic space.
- has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for each 1 hour of tutorial time in the direction of a participant’s RQAP re-registration.
- has been authorized by ACRP for persevering with schooling in medical analysis. ACRP will present 1 ACRP contact hour for each 45-60 minutes of certified materials.
The Small Enterprise and Business Help (SBIA) program within the Heart for Drug Analysis and Analysis gives steering, education and updates for regulated business.