This training workshop is intended for Qualified persons for pharmacovigilance and national PV officers who would like to improve their daily practice and better understand regulatory expectations and practical implications. The workshop is led by an expert instructor who has been a EU/EEA QPPV for 17 years and helped establish the EU QPPV Forum with which he is still involved. Together with two experts from MOHAP UAE and CAPA (Ministry of Health and Population Egypt), they aim to interactively help you better understand the daily challenges you face and hear about solutions from others in similar situations.At the end of this training course you should be able to:
Understand the new template and content of a Pharmacovigilance Master File as per Arab Guidelines
Plan and prepare for pharmacovigilance audits & inspections
Know the processes for safety and risk communications
Familiarize and know the Periodic Safety Update and Benefit/Risk Evaluation reports per the Arab Guidelines
Comprehend the principles of benefit risk management and monitoring effectiveness of risk minimization
Understand the place of epidemiology in Pharmacovigilance and need for Post Authorization Safety Studies
Head of the Egyptian Pharmaceutical Vigilance Center (EPVC)- Central Administration Of Pharmaceutical Affairs – Ministry of Health
Hadir holds B.Sc. Clinical pharmacy from Ain Shams University (2000), a Certificate in Executive Management from Harvard School of Public Health USA (2010) and Clinical Pharmacy Diploma from Cambridge Regional College UK in cooperation with National Training Institute Egypt (2011).
She has 16 years experience at the Egyptian Pharmaceutical Authority with special competence in establishing new systems. On 2009 she established a complete system for hospital pharmacy inspection at Ministry of Health; moreover she was a project manager of WHO project for enhancing a functional system for rational use of medicines.
On 2010 she was assigned to be a principal contributor in the establishment of EPVC from scratch as well as the national pharmacovigilance system. Through her position as the Head of the Human Pharmacovigilance Department at the Egyptian Pharmaceutical Vigilance Center (EPVC) & Rapporteur of Pharmacovigilance Committee; her role included developing EPVC operating manuals, standard operation procedures (SOPs), Egyptian Pharmacovigilance guidelines (for Marketing Authorization Holders & another one for Healthcare Professionals), capacity building plans, working systems (Operating system, Archiving system, Performance Evaluation system, Training system, Pharmacovigilance Committee system) and drafting Egyptian Pharmacovigilance legislation, team coaching & operations management.
On 2016 she has been promoted to be the Head of EPVC with a mission to upgrade the Egyptian Pharmacovigilance system & strengthen the Pharmacovigilance practice in Egypt. In addition she is a member in National Pharmcovigilance committee as well as Non-reference medicinal products evaluation Committee
She was a principal contributor in issuing the “Good Pharmacovigilance Practice guidelines in Arab Countries” (GVP-Arab). She participated in the 2nd WHO International Consultation of Experts for Regulatory System Strengthening. She contributed in issuing the new Egyptian Pharmacy practice Law/ Egyptian Drug Authority Law. She also contributed in issuing the Egyptian Good Clinical Practice (Eg- GCP) and the Egyptian guidelines for herbal medicines.
In addition she is acting as project coordinator in the resources & capacity building project of the National Drug Quality Task force.
Her professional interests include Pharmacovigilance, Pharmacovigilance regulations, operational management, quality and inspection.
Dr. Ahmed Hegazi
ISoP – Member
ISoP Middle East Chapter – Committee member
PV Middle East group – Founder
Egyptian Medical Syndicate – Member
Work experienceCurrent appointment:
Head of Global Patient Safety (GPS) – Intercontinental Region – Merck
Positions held (chronologically):
Mar 1995 – Mar 1996 Internship (House Officer), Alexandria University, Egypt
Apr 1996 – Jan 1999 Senior Medical Representative, Pfizer, Egypt
Feb 1999 — Aug 2002 Field Trainer, Pfizer, Egypt
Sep 2002 – May 2008 Product Physician, Pfizer, Saudi Arabia
May 2008 – Dec 2009 Medical Manager, Pfizer, Saudi Arabia
Jan 2010 – Jan 2011 Senior Medical Manager, Pfizer, Saudi Arabia
Jan 2011 – Nov 2011 Regional Medical Manager Middle East, Merck
Dec 2011 – Feb 2013 Head of Medical department, Merck, Saudi Arabia
Mar 2013 – Mar 2014 Regional Safety Manager – Intercontinental Region, Merck
Mar 2014 — Present Head of Global Patient Safety – Intercontinental Region, Merck
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