CDER SBIA Webinar: Updates on FDA’s Drug-Drug Interaction Final Guidances April 24, 2020

Updates on FDA’s Drug-Drug Interaction Final Guidances Friday, April 24, 2020 | 1:30 p.m. to 3:00 p.m. ET This webinar is FREE.

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This webinar will discuss two FDA final guidances that provide a systemic approach to the evaluate the drug-drug interaction (DDI) potential of investigational drugs and describe how the approach can be implemented. The two final guidances are: In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions LEARNING OBJECTIVES At the end of this webinar, participants should be able to: Understand the important role of in vitro DDI evaluations and how they inform clinical DDI assessment. Describe the need for, timing of, and multiple design features of clinical DDI studies. Interpret in vitro and clinical DDI study findings and translation of those findings into DDI management strategies that health care providers communicate to patients. INTENDED AUDIENCE Scientists in pharmaceutical companies and contract research organizations working on drug metabolism, pharmacokinetics, and clinical pharmacology Regulatory reviewers and policy makers working in those areas Academic researchers in those fields Pharmacists Healthcare providers prescribing drugs to patients CONTINUING EDUCATION This course: 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 RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration. has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material. Real-time attendance is required for certificate of completion. Certificates are only available two weeks after the event.