Short Course* Registration: 8:00AM-5:00PM
The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved to respond to the increasingly global face of drug development. ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
Harmonization is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. The key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines.
This introductory training course will provide an overview of the ICH process, the value that ICH brings to drug regulation in Canada, as well as ICH quality guidelines.
- ICH Introduction
- Q3D: Impurties: Guideline for Elemental Impurities
- Q9: Quality Risk Management
- Q10: Pharmaceutical Quality System
- Q11 Questions and Answers Document: Selection and Justification of Starting Materials for the Manufacture of Drug Substances
- Q12: Technical and Regulatory Considerations for Pharmaceutical Product Life Cycle Management
*Short Courses are not included in the conference registration and require a separate fee.
What you will learn
At the conclusion of this short course, participants should be able to:
- Understand the ICH process and how ICH guidelines are developed and implemented in Canada
- Recognize the value that ICH brings to drug regulation in Canada
- Describe and understand key ICH quality guidelines
- Recognize how and when to use the guidelines throughout the life cycle of a drug product
Who should attend?
Professionals involved in:
- Drug safety
- Regulatory affairs
- Clinical development/clinical sciences
- Project management