Photostability ICH Q1B: Practical Interpretation and Execution

This course will cover an introduction to the chemistry of light.  Its role and understanding for pharmaceutical applications.  We will look at the ICH Q1B Photostabilty guideline and overview its minimum exposure requirements.  We will interpret the terms presented in the guideline for background understanding.  We will cover the types of light sources, means of sample presentation, execution of sample analysis and types of tests, and practical means of interpretation of the results for a photostability decision.  Present a format for a photostability protocol.  Learn of ways to protect photoliable drugs.  A wrap up with a summary of key take home concepts.

Why You Should Attend:

In conducting drug development in a global environment, it is important to be able to interpret and execute the requirements of regulatory standards.  The International Conference on Harmonization (ICH) has published a Quality guideline on photostability (Q1B) that must be understood and executed correctly for subsequent regulatory approval.  This course presents background knowledge and practical interpretation of the guideline to come to a photostability decision for your drug development program.  

Areas Covered In The Session:

• Chemistry of Light
• Pharmaceutical Application
• ICH Q1B guideline
  • Overview of requirements
  • Terms
  • Light Sources
  • Sample Presentation
  • Sample Analysis
  • Judgement of Results
• Photostability Testing Protocol
• Protection of Photoliable Drugs
• Seminar Wrap Up
• Technical References

Who Should Attend:

• Quality Departments
• Regulatory Affairs Departments
• Analytical Scientist
• Formulations Scientist
• Regulatory Scientist
• Technical Managers of who oversee drug development in a regulated environment

Course Director: SCOTT R. THATCHER ‎

Scott Thatcher is a 20+ year veteran of the pharma/biopharma industry. He is a published author in analytical chemistry and photostability studies.  He has contributed to the CMC development and launch of multiple drug programs in different delivery systems. He has executed stress studies for the development and validation of 100s of analytical methods. He is an expert in the interpretation of the ICH Q1B guideline and has contributed to multiple regulatory submissions that met regulatory requirements and subsequent agency approval.