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FDA | CDER | Small Business and Industry Assistance (SBIA)
ICH M12 Drug-Drug Interaction Studies Final Guidance
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October 9, 2024 | 1:00 PM - 3:00 PM ET
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This webinar will discuss the ICH M12 Drug Interaction Studies guidance, which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. The guidance describes a systemic approach to evaluation of the drug interaction potential of investigational drugs during drug development and regulatory review.
The discussion will include content related to the full scope of the guidance: in vitro evaluations, clinical studies, predictive modeling, study interpretation, risk assessment, and risk management. The subject matter experts will communicate how the various components of a drug interaction program fit together to inform safe and effective use of drugs in individuals who take multiple drugs.
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CONTINUING EDUCATION (CE)
Real-time participation is required for the certificate of attendance, which can be used in support of CEs for the following professional organizations: RAPS, SOCRA, SQA, and ACRP. Certificates are only available during the two weeks post-event. For more information, see details on our webpage.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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