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:

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.

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Medical Device
Regulations Summit 2020

Exploring EU MDR and IVDR updates and preparing company for new requirements implementation.
  • 22 Sep 2020
  • Prague, CZ
  • Pharma
Day 1: Tuesday, 22 September 2020
CASE STUDY: EU MDR Vigilance System – EU Vigilance Decision Tree and Optimal Set Up.
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Medical Device
Regulations Summit 2020

Exploring EU MDR and IVDR updates and preparing company for new requirements implementation.
  • 22 Sep 2020
  • Prague, CZ
  • Pharma
Day 2: Wednesday, 23 September 2020
WORKSHOP: EU MDR Post Market Surveillance – Requirements and Lessons Learned.
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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
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