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  4. Joint US FDA – Health Canada ICH Public Meeting 2025 - 02/11/2025
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Virtual | Virtual

Event Title
Joint US FDA – Health Canada ICH Public Meeting 2025
February 11, 2025

Date:
February 11, 2025
Time:
11:00 a.m. - 3:00 p.m. ET

AGENDA

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ABOUT THIS EVENT (Hosted by CDER SBIA)

FDA and Health Canada will be co-hosting a regional public meeting to provide information to stakeholders and solicit input prior to the next International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Biannual Assembly meeting scheduled for May 13-14, 2025. This Joint US FDA – Health Canada ICH Public Meeting will include presentations by FDA, Health Canada, and PhRMA experts on ICH guidelines recently reaching significant ICH milestones.

INTENDED AUDIENCE

North American regulators, industry, and other stakeholders interested in learning more about current efforts conducted under the auspices of the ICH to develop and harmonize scientifically driven global standards for safe, effective, and high-quality pharmaceuticals.

This event is expected to be of broad interest to industry sponsors including innovator and generic companies. One of the presentations will be on the M13 Bioequivalence for Immediate Release Solid Oral Dosage Forms guideline which is of considerable interest to the generics industry.

TOPICS COVERED

Recent final ICH guidelines:

  • Pediatric extrapolation (i.e., E11A ICH guideline). This guideline supports the development and authorisation of pediatric medicines.
  • Bioequivalence (BE) for Immediate-Release Solid Oral Dosage Forms (i.e., M13A ICH guideline). This BE guideline focuses on bioequivalence study considerations and data analysis for a non-replicate study design.

Recent draft ICH guidelines:

  • General Principles for Model-Informed Drug Development (i.e., M15 ICH guideline).
  • Good Clinical Practice Annex 2 (i.e., E6(R3) ICH Annex 2).

Additional guidelines expected to reach milestones in coming months:

  • Final Good Clinical Practice Guideline and Annex 1 (i.e., E6(R3) ICH guideline).
  • Targeted Revisions of the ICH Stability Guideline Series (i.e., Q1/Q5 ICH guideline).
  • Bioequivalence (BE) for Immediate-Release Solid Oral Dosage Forms (i.e., M13B ICH guideline). This draft BE guideline includes biowaiver considerations for additional strengths.

FDA RESOURCES

CONTINUING EDUCATION

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,
  • 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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