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
Abdullah Alreshaidan
Regulatory Affairs Director at Spectropharma
Abdullah Bader Alreshaidan is a distinguished regulatory affairs executive with 15 years of experience in the pharmaceutical industry. He dedicated 9 years to the Saudi Food and Drug Authority (SFDA) within the Quality Evaluation Department. Subsequently, he embarked on a successful career in the private sector, initially serving as a Pharmacovigilance Manager for Saudi Arabia & Gulf countries at les laboratoires Servier. He then advanced to the role of Regulatory Affairs Director at Saudi Amarox, followed by SPIMACO ADDWAEIH, both prominent Saudi pharmaceutical companies. Currently, he serves as the Regulatory Affairs Director at Spectropharma. Abdullah holds a Bachelor of Science in Pharmaceutical Sciences from King Saud University and a Master of Science in Drug Discovery and Pharmaceutical Sciences from the University of Nottingham. He is recognized for his strategic leadership and unwavering dedication to regulatory excellence in the pharmaceutical domain.
Workshop Partner
