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SESSION 8: ENSURING COMPLIANCE WITH THE NEW PHARMACOVIGILANCE REGULATIONS
Session Chair(s)
Hisham Aljadhey
Executive President, Saudi FDA, 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)
Adel A. Al Harf, PHD
Executive Vice President for Drug Sector, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Update on Pharmacovigilance Regulations in Middle East
Tariq Alhawassi
, College of Pharmacy, King Saud University, Saudi Arabia
Adverse Drug Reactions: The Role of Causality Assessment Scales in Pharmacovigilance
Syed Rizwanuddin Ahmad, MD, MPH, FISPE
Ex-Consultant/Safety Reviewer, FDA, Assoc Prof (adjunct), Rutgers, Georgetown, Drug Safety Consultant, United States
Practical Considerations in Benefit-Risk Assessment
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