Fayez Abou Hamad

Fayez Abou Hamad, TERUMO EUROPE - Qepler Summits And Conferences

Fayez Abou Hamad

MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager
TERUMO EUROPE
Limburg, Belgium
TERUMO EUROPE
Owner and founder
MDV-SOLVE MEDICAL DEVICE CONSULTING
Limburg, Belgium

Fayez is a pharmacist with more than 15 years experience in the quality assurance within the pharmaceutical and medical device industry.

Since 2008, Fayez joined Terumo Europe where he held roles of increasing responsibility in maintaining quality, risk management and clinical evidence systems.

In his current position, he is responsible for global complaint handling and vigilance systems.

Fayez is also a certified lead auditor for medical device quality system regulations.

Related Sessions:

Qepler - Drug/Device Combination Products Summit thumbnail Details

Drug/Device Combination
Products Summit 2018

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 04 December 2018
BLOCK: MITIGATING THE RISK OF COMPLIANCE UNCERTAINTY.
CASE STUDY: TREND REPORTING under MDR – Change and Impact.
  • Highlights and reinforcements of the MDR on Trend reporting requirement
  • Main changes compared to MEDDEV 2.12/1 rev.8
  • Use Quality Management System elements to meet Trend reporting requirement
  • Practical approach for implementation

Learning outcome:
The participants are expected to have a very good understanding of the Trend reporting requirements for medical device under MDR, to have a better overview of the main changes compared to MEDDEV and to return back home with suitable approach and strategy for implementation.

View Details
Qepler - Medical Device Regulations Virtual Summit thumbnail Details

Medical Device
Regulations Summit 2021

Exploring EU MDR and IVDR updates and preparing company for new requirements implementation.
  • 08 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 08 July 2021
CASE STUDY: EU MDR Vigilance System – EU Vigilance Decision Tree and Optimal Set Up.
View Details
Qepler - Medical Device Regulations Virtual Summit thumbnail Details

Medical Device
Regulations Summit 2021

Exploring EU MDR and IVDR updates and preparing company for new requirements implementation.
  • 08 Jul 2021
  • Virtual,
  • Pharma
Day 2: Friday, 09 July 2021
WORKSHOP: EU MDR Post Market Surveillance – Requirements and Lessons Learned.
View Details
Qepler - 2nd Annual Drug/Device Combination Products Summit thumbnail Details

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 2: Thursday, 05 December 2019
CASE STUDY: Medical Device Vigilance system under MDR - Basics and Approach for Implementation.
  • Change in definitions of serious incident and FSCA
  • Change in the vigilance and FSCA reporting criteria
  • Change in vigilance reporting time-frame
  • Change in the route of submission for both of vigilance reporting and FSCA
  • Trend report requirement and implementation approach
  • Vigilance reporting implementation approach – EU decision tree
View Details
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