This free FDA-led forum, held April 4-5, offers you the opportunity to interact with FDA subject matter experts involved in all aspects of the agency’s Generic Drug Review Program. Whether you choose to attend in person or via webcast, obtain up-to-date information on program progress and current initiatives and journey with us through a high-level regulatory overview of the complete ANDA review pathway. The full agenda and registration are available online. In addition, the Regulatory Affairs Professionals Society (RAPS) has pre-approved the event for up to 12 credits towards RAC recertification.
Keynote Speaker: Kathleen Uhl, M.D., Director, Office of Generic Drugs
Presentations and panel discussions include:Office of Generic Drugs (OGD) Regulatory Science Update
Office of Pharmaceutical Quality (OPQ) UpdateGDUFA II Pre-filing policy issuesClinical Bioequivalence
and many more!
Office of Pharmaceutical Quality (OPQ) UpdateGDUFA II Pre-filing policy issuesClinical Bioequivalence
and many more!
For more information, view the event website.
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