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SESSION 8: ENSURING COMPLIANCE WITH THE NEW PHARMACOVIGILANCE REGULATIONS
Session Chair(s)
Hisham Aljadhey
Interim Dean, College of Pharmacy
King Saud University, Saudi Arabia
The main aim of this session is to provide marketing authorization holders (MAHs) with background information on current pharmacovigilance regulations and how to improve their capabilities in order to comply with the requirements of good pharmacovigilance practices.
Speaker(s)
Update on Pharmacovigilance Regulations in Middle East
Adel A. Al Harf, PhD
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Executive Vice President for Drug Sector
Adverse Drug Reactions: The Role of Causality Assessment Scales in Pharmacovigilance
Tariq Alhawassi
College of Pharmacy, King Saud University, Saudi Arabia
Practical Considerations in Benefit-Risk Assessment
Syed Rizwanuddin Ahmad, MD, MPH, FISPE
Drug Safety Consultant, United States
Ex-Consultant/Safety Reviewer, FDA, Assoc Prof (adjunct), Rutgers, Georgetown
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