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  4. FDA and Health Canada Regional ICH Consultation - 05/14/2021 - 05/14/2021
  1. News & Events for Human Drugs

Meeting

Event Title
FDA and Health Canada Regional ICH Consultation
May 14, 2021

Scheduled

Date:
May 14, 2021
Time:
1:00 PM - 4:00 PM ET


 

FDA and Health Canada will be co-hosting a regional public meeting to provide information and receive comments on current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) efforts and anticipated future topics.  The public meeting will include discussion of harmonization guidelines reaching significant ICH milestones and other topical issues.  Issues to be discussed will include good clinical practice principles, lifecycle management, model-informed drug development, and patient-focused drug development. 

Agenda

INTENDED AUDIENCE

  • North American regulators
  • Regulated industry
  • 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. 

RESOURCES

  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use https://www.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 credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • 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 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.
  • has been 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 AND QUESTIONS

 

 

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