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Session 1: International Pharmacovigilance
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV, MSD, Netherlands
Shahinaz Badr, PharmD
Founder & Managing Director, Vigilance Gate FZ,LLC, 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
Head of Pharmacovigilance Section – Drug Department, Ministry of Health and Prevention (MoHAP), United Arab Emirates
GVP Updates from South Africa
Mafora Florah Matlala
Pharmacovigilance Manager, South African Health Products Regulatory Authority, South Africa
Tunisian GVP Guidelines
Riadh Daghfous
Head of Pharmacovigilance, Centre National de Pharmacovigilance, Tunisia
Updates from Egypt on GVP Guidelines
Aalaa Afdal Mogheith, MPA, MPharm
Head of Pharmaceutical Vigilance, General Administrator, Egyptian Drug Authority (EDA), Egypt
SFDA GVP Version 3 Updates
Abdulltif Ayid Alotibe, MPH
Head of Pharmacovigilance inspection, Saudi Food and Drug Authority (SFDA) , Saudi Arabia
Updates in the APAC Region: Updates on China GVP in Comparison to EMA/ICH Regulations
Jan Petracek, MD, MSc
CEO, iVigee Services a.s., Czech Republic
Updated French GVP
Sandrine Valiere, PharmD
Europe Region Pharmacovigilance Head, Sanofi, France
Updates of FDA Drug Safety Regulations: Approaches Towards Harmonization of Regulations
Narayan Nair, MD
Associate Director Regulatory Affairs, Office of Biostatistics and Pharmacovigil, FDA, United States
Panel discussion with Q&A
Narayan Nair, MD
Associate Director Regulatory Affairs, Office of Biostatistics and Pharmacovigil, FDA, United States
Panel discussion with Q&A
Georgy Genov, MD
Head of Pharmacovigilance Office, European Medicines Agency, Netherlands
Panel discussion with Q&A
Alison Cave
Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Panel discussion with Q&A
Abdulltif Ayid Alotibe, MPH
Head of Pharmacovigilance inspection, Saudi Food and Drug Authority (SFDA) , Saudi Arabia
Panel discussion with Q&A
Laila Mohammad Kazim
Head of Pharmacovigilance Section – Drug Department, Ministry of Health and Prevention (MoHAP), United Arab Emirates
Panel discussion with Q&A
Aalaa Afdal Mogheith, MPA, MPharm
Head of Pharmaceutical Vigilance, General Administrator, Egyptian Drug Authority (EDA), Egypt
Panel discussion with Q&A
Mafora Florah Matlala
Pharmacovigilance Manager, South African Health Products Regulatory Authority, South Africa
Panel discussion with Q&A
Riadh Daghfous
Head of Pharmacovigilance, Centre National de Pharmacovigilance, Tunisia
Panel discussion with Q&A
Jan Petracek, MD, MSc
CEO, iVigee Services a.s., Czech Republic
Panel discussion with Q&A
Sandrine Valiere, PharmD
Europe Region Pharmacovigilance Head, Sanofi, France
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