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Workshop Objectives

  • Understand key stability guidelines, including International and Saudi Food and Drug Authority requirements. 
  • Explain the purpose, types, and key parameters of stability studies. 
  • Apply specifications, analytical methods, and acceptance criteria. 
  • Interpret stability data and determine product shelf life. 
  • Describe in-use, compatibility, and forced degradation studies. 
  • Recognize SFDA-specific regulatory expectations.


2 September 

Workshop Agenda

  • 11:00 – 11:45: Major global & local guidelines (ICH Q1A(R2) & SFDA)
  • 11:45 – 12:15: Purpose & key parameters
  • 12:15 – 12:45: Types of studies: Long-term, accelerated, and intermediate conditions
  • 12:45 – 13:00: Discussion
  • 13:00 – 13:15: Coffee Break
  • 13:15 – 13:45: Specification, analytical methods, and acceptance criteria
  • 13:45 – 14:15: Reporting: Data presentation, statistical analyses, and shelf-life determination
  • 14:15 – 14:45: In-Use Stability Studies: Purpose and scope
  • 14:45 – 15:00: Discussion
  • 15:00 – 15:45: Lunch Break
  • 15:45 – 16:05: Compatibility Studies for Injectables: Purpose and scope
  • 16:05 – 16:25: Forced Degradation Studies: Purpose, scope, and regulatory impact
  • 16:25 – 16:45: SFDA-specific considerations
  • 16:45 – 17:00: Q & A

Our Instructor

Dr. Suliman Alshamaimri

Regulatory Affairs Excellence Executive Manager, SPIMACO

Workshop Partner

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