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Riyadh Marriott Hotel

2015年11月17日 (火) 午前 8:00 - 2015年11月18日 (水) 午後 5:15

King Saud Road, Riyadh 11464, Saudi Arabia

11th Middle East Regulatory Conference (MERC) 2015

SESSION 8: ENSURING COMPLIANCE WITH THE NEW PHARMACOVIGILANCE REGULATIONS

Session Chair(s)

Hisham  Aljadhey

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)

Adel A. Al Harf, PHD

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

Tariq  Alhawassi

Adverse Drug Reactions: The Role of Causality Assessment Scales in Pharmacovigilance

Tariq Alhawassi

College of Pharmacy, King Saud University, Saudi Arabia

Syed Rizwanuddin  Ahmad, MD, MPH, FISPE

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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