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Visit the CDER Small Business and Industry Assistance Webpage

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 Download Slides

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/