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Session 1: International Pharmacovigilance
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV
MSD, Netherlands
Shahinaz Badr
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Pharma Quality Europe, United Arab Emirates
In the era of the rapid evolvement of medicines, pharmacovigilance is also evolving to keep the patient safety while meeting patient’s needs across the world. Pharmacovigilance regulations are developing and evolving in parallel, to ensure the ultimate goal of patient safety. With that in mind, we bring you the latest updates of GVP guidelines and related regulations that you as QPPV need to be aware of to maintain your oversight on all your territories.
Speaker(s)
Updates on UAE GVP Guidelines
Laila Mohammad Kazim
Ministry of Health and Prevention (MoHAP), United Arab Emirates
Head of Pharmacovigilance Section – Drug Department
GVP Updates from South Africa
Mafora Florah Matlala
South African Health Products Regulatory Authority, South Africa
Pharmacovigilance Manager
Tunisian GVP Guidelines
Riadh Daghfous
Centre National de Pharmacovigilance, Tunisia
Head of Pharmacovigilance
Updates from Egypt on GVP Guidelines
Aalaa Afdal Mogheith, MPA, MPharm
Egyptian Drug Authority (EDA), Egypt
Head of Pharmaceutical Vigilance, General Administrator
SFDA GVP Version 3 Updates
Abdulltif Ayid Alotibe, MPH
Saudi Food and Drug Authority (SFDA) , Saudi Arabia
Head of Pharmacovigilance inspection
Updates in the APAC Region: Updates on China GVP in Comparison to EMA/ICH Regulations
Jan Petracek, MD, MSc
Ivigee, Czech Republic
CEO
Updated French GVP
Sandrine Valiere, PharmD
Sanofi, France
Europe Region Pharmacovigilance Head
Updates of FDA Drug Safety Regulations: Approaches Towards Harmonization of Regulations
Narayan Nair
FDA, United States
Division Director, Division of Epidemiology, CBER
Panel discussion with Q&A
Narayan Nair
FDA, United States
Division Director, Division of Epidemiology, CBER
Panel discussion with Q&A
Georgy Genov, MD
European Medicines Agency, Netherlands
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
Panel discussion with Q&A
Alison Cave, PhD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
Panel discussion with Q&A
Abdulltif Ayid Alotibe, MPH
Saudi Food and Drug Authority (SFDA) , Saudi Arabia
Head of Pharmacovigilance inspection
Panel discussion with Q&A
Laila Mohammad Kazim
Ministry of Health and Prevention (MoHAP), United Arab Emirates
Head of Pharmacovigilance Section – Drug Department
Panel discussion with Q&A
Aalaa Afdal Mogheith, MPA, MPharm
Egyptian Drug Authority (EDA), Egypt
Head of Pharmaceutical Vigilance, General Administrator
Panel discussion with Q&A
Mafora Florah Matlala
South African Health Products Regulatory Authority, South Africa
Pharmacovigilance Manager
Panel discussion with Q&A
Riadh Daghfous
Centre National de Pharmacovigilance, Tunisia
Head of Pharmacovigilance
Panel discussion with Q&A
Jan Petracek, MD, MSc
Ivigee, Czech Republic
CEO
Panel discussion with Q&A
Sandrine Valiere, PharmD
Sanofi, France
Europe Region Pharmacovigilance Head
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