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  4. ICH M12 Drug-Drug Interaction Studies Final Guidance - 10/09/2024
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Virtual | Virtual

Event Title
ICH M12 Drug-Drug Interaction Studies Final Guidance
October 9, 2024

Date:
October 9, 2024
Time:
1:00 PM - 3:00 PM ET

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ABOUT THIS EVENT (Hosted by CDER SBIA)

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.

INTENDED AUDIENCE

  • Scientists in pharmaceutical companies, contract research organizations, and consultant firms who work on drug metabolism, pharmacokinetics, and clinical pharmacology
  • Regulatory reviewers and policy makers working in the above areas
  • Academic researchers in fields investigating drugs interactions
  • Healthcare providers prescribing drugs to patients or consulted by patients

TOPICS

  • In vitro and clinical assessment of DDIs mediated by:
    • CYP and UGT enzymes
    • Drug transporters
  • Applications of modeling approaches and the utility of endogenous biomarkers
  • Data interpretation
  • Risk assessment and risk management

OBJECTIVES

  • Recognize the important role of in vitro DDI evaluations and how they inform clinical DDI assessment
  • Describe the need for, timing of, and study design of clinical DDI studies
  • Explain in vitro and clinical DDI study findings and modeling predictions, and translation of those results into DDI management strategies to mitigate DDI risk
  • Identify the differences between the ICH M12 DDI guidance and the previous FDA In Vitro and Clinical DDI guidances

SPEAKERS

Kellie Reynolds, Pharm.D.
Director
Division of Infectious Disease Pharmacology (DIDP) | Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER

Xinning Yang, Ph.D.
Policy Lead
Guidance & Policy Team | OCP | OTS | CDER

Helen Heymann, MMSc, PMP, CPH
Regulatory Health Project Manager
Executive Program and Project Management Staff | OCP | OTS | CDER

Panelist
Rajanikanth Madabushi, Ph.D.
Associate Director
Guidance & Policy Team | OCP | OTS | CDER

FDA RESOURCES

CONTINUING EDUCATION

This activity has been approved for 2.0 CE hours for physicians, pharmacists, and nurses. Real-time attendance is required and for further details, see the detailed announcement.

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 a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • 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.
  • 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.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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