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Agenda

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ABOUT THIS MEETING

FDA and Health Canada will be co-hosting a regional public meeting to provide information and solicit input prior to the next ICH biannual Assembly and Management Committee meetings scheduled for May 21 - 25, 2022.

The public meeting will include discussion of harmonization guidelines recently reaching significant ICH milestones.

TOPICS COVERED

• ICH Background
• ICH Guidelines Reaching Key Milestones

INTENDED AUDIENCE

North American regulators, industry, and other stakeholders interested in learning more about current efforts conducted under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop and harmonize scientifically-driven, global standards for safe, effective, and high-quality pharmaceuticals.

FDA RESOURCES

• ICH.org

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.
• 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
• pre-approved by 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.
• approved by 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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