Fayez Abou Hamad, TERUMO EUROPE - Qepler's Drug/Device Combination Products Summit 2018

Fayez Abou Hamad

MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager
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

  • 4-December-2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday 4, 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