Regulatory Affairs Executive
Egyptian Drug Authority
Total years of experience :25 years, 9 Months
Eight years as Senior Registration officer/Regulatory Affairs (Registration Pharmaceutical/Biological/Cosmetics/Medical Devices) At Egyptian Drug Authority EDA
(Pricing committee & Technical committee).At Egyptian Drug Health Authority
My job activities:
* Reviewer /Assessor for New drug (Brand &Generic) for pharmaceutical.
* Reviewer / Assessor for CPP &All Master files .
* Reviewer / Assessor forName / Art work (carton box information)
* Reviewer / Assessor for scientific file.
*Reviewer / Assessor for (Variation cases)
*Reviewer / Assessor for Medical Leaflet(SmPC)
Pricing committee :( One year)*
My job activities:
Reviewer / Assessor for file pricing.*
Reviewer / Assessor for cost sheet.*
Reviewer / Assessor for countries price.*
* Reviewer / Assessor for committee and discussion.
Note: Preparation Pharmaceutical Files according to CTD System
2/Five years as QA Inspection/ GMP Inspector /Auditor:
*For pharmaceutical factories (sterile terminal sterilization/under aseptic condition) & (non- sterile products (At Egyptian Drug Authority)
*For Biological GMP Inspector VACSERA factories(BCG/HEPITITIS/TETANUS/INSULIN)( At Egyptian Health Authority)
*External GMP Inspector /Auditor (Outside Egypt) for ( cipla, Clarisse, Wintac, Golden cross &Health line) Indian pharmaceutical companies.
*Note: Auditing according to WHO regulations/EMA regulations (Good Manufacture Practice, Good Storage Practice) (GLP &GSP&GMP).
3/ Two years as QPPV(Qualified Personal PharmacoVigilance):
In Egyptian Pharmacovigilance Center (EPVC).
At Egyptian Drug Authority
Eight years as Senior Registration officer/Regulatory Affairs (Registration Pharmaceutical/Biological/Cosmetics/Medical Devices) At Central Administration of Pharmaceutical Affairs (CAPA).
(Pricing committee & Technical committee).At Egyptian Drug Health Authority
My job activities:
* Reviewer /Assessor for New drug (Brand &Generic) for pharmaceutical.
* Reviewer / Assessor for CPP &All Master files .
* Reviewer / Assessor forName / Art work (carton box information)
* Reviewer / Assessor for scientific file.
*Reviewer / Assessor for (Variation cases)
*Reviewer / Assessor for Medical Leaflet(SmPC)
Pricing committee :( One year)*
My job activities:
Reviewer / Assessor for file pricing.*
Reviewer / Assessor for cost sheet.*
Reviewer / Assessor for countries price.*
* Reviewer / Assessor for committee and discussion.
Note: Preparation Pharmaceutical Files according to CTD System
2/Five years as QA Inspection/ GMP Inspector /Auditor:
*For pharmaceutical factories (sterile terminal sterilization/under aseptic condition) & (non- sterile products (At Egyptian Health Authority)
*For Biological GMP Inspector VACSERA factories(BCG/HEPITITIS/TETANUS/INSULIN)( At Egyptian Health Authority)
*External GMP Inspector /Auditor (Outside Egypt) for ( cipla, Clarisse, Wintac, Golden cross &Health line) Indian pharmaceutical companies.
*Note: Auditing according to WHO regulations/EMA regulations (Good Manufacture Practice, Good Storage Practice) (GLP &GSP&GMP).
3/ Two years as QPPV(Qualified Personal PharmacoVigilance):
In Egyptian Pharmacovigilance Center (EPVC).
At Central Administration of Pharmaceutical Affairs (CAPA)
Senior Regulatory Affairs Registration for Pharmaceutical &Cosmetics &Biological &Medical Devices Egyptian Drug Authority Registration Pharmaceutical/Cosmetics/Biolgical/Medical devices) In Egyptian Drug Authority (EDA). (Till Now (EDA) (Pricing committee & Technical committee &Variation). In Egyptian Drug Authority Eight years as Senior Registration officer/Regulatory Affairs: (Registration Pharmaceutical /Cosmetics) In Egyptian Drug Authority (EDA). (Till Now) (EDA) (Pricing committee & Technical committee &Variation). In Egyptian Drug Authority My job for Cosmetics products (In Registration Department): Assessment registration file & Review (formulation and Composition document &Art Work or Mock up & The manufacturing Contracts with toll company &preparation the cosmetics file to display on the technical committee of cosmetics &Change and Choose the name of the product &review for all contracts for sale and purchase of cosmetics products) Achievements: In 2018 review 450 Files. In 2019 review 500 Files. In 2020 review 550 Files. My job activities for Pharmaceutical products: * Reviewer /Assessor for New drug (Brand &Generic) for pharmaceutical. * Reviewer / Assessor for CPP &All Master files. * Reviewer / Assessor for Name / Art work (Labeling ) (carton box information) * Reviewer / Assessor for scientific file &Quality file. *Reviewer / Assessor for (Variation cases) *Reviewer / Assessor for Medical Leaflet (SmPC) My job activities pricing committee: * Reviewer / Assessor for file pricing * Reviewer / Assessor for cost sheet * Reviewer / Assessor for countries price Note: Preparation 200 Pharmaceutical Files according to CTD System Six years as QA Inspection/ GMP Inspector /Auditor: *For pharmaceutical factories (sterile terminal sterilization/under aseptic condition) & (non- sterile products (in Egyptian Drug Authority) *For Biological VACSERA factories (BCG/HEPITITIS/TETANUS/INSULIN) (in Egyptian Drug Authority) *External GMP Inspector /Auditor (Outside Egypt) for (Cipla, Clarisse, Wintac, Golden
Cross &Health line)
Indian pharmaceutical companies. Note: Auditing according to WHO regulations/EMA regulations (Good Manufacture Practice, Good Storage Practice) (GLP &GSP&GMP). Two years as Pharmacovigilance Assessor (PV Assessor): In Egyptian Pharmacovigilance Center (EPVC) In Egyptian Drug Authority (EDA) 09/1997 - 09/2003 Cairo, EGYPT My job activities: Assessment all files for the registration /pharmacovigilance According to decree of Health authority and follow up. • The Pharmacovigilance Specialist will be responsible for case management activities for Post-Marketing and Investigational Products across their country/territory in accordance with PV processes and regulations, company policies and procedures. • The Pharmacovigilance Assessor will work independently to process Adverse Events. • Conduct reconciliation of (serious) adverse event reports received. • Translate and process spontaneous and solicited / clinical trial adverse event reports across their country/territory and enter them into the Global Safety database. ( XML files by IT personal ) • Signal detection and authoring signal work-up documents. • Working closely with the drug safety physician. • Authoring aggregate safety reports (PSURs, PBRERs) sections and RMPs. • Preparation of site master files (PSMF) & all SOP and validation of system. • Review all ICSRs & follow up & data base of Vigiflow website. • Follow up all yellow cards for Pharmaceutical products. • Communication with other drug health authority &
My job activities:
Assessment all files for the registration /pharmacovigilance According to decree of Health
authority and follow up.
• The Pharmacovigilance
Bachelor of Pharmaceutical Cairo University Degree Good