Working Group of Quality Managers (WGQM)
Introduction/Overview
In support of the efforts of the European Medicines Regulatory Network (EMRN) with regard to public and animal health, the HMA Working Group of Quality Managers (WGQM) shall provide guidance relating to quality management and best practice benchmarking.
The Working Group:
- will act as a forum for discussion to agree on common principles to be applied throughout the EMRN,
- will operate to improve the exchange of quality management expertise and to contribute towards the development of best practices for quality management
- and will report to HMA on all cases where consistent practices are considered to be in the interest of the EU.
In 2018 the WGQM took over the remaining responsibilities of the Pharmacovigilance Audit Facilitation Group (PAFG).
Mandate
- Mandate| pdf
Document adopted in September 2020 - version 4
- HMA Guide to Managing Declarations of Interest | pdf
Document adopted in February 2020 - version 2
Members and Representatives
The WGQM is composed of quality managers (or contact persons) of each NCA, EMA and EDQM
The WGQM is currently chaired by Klaus Stüwe (AGES, AT), and the vice-chair is Brigitte Mauel-Walbröl (BfArM, DE).
The WGQM Mentor is Professor Siniša Tomić (HALMED, HR)
Contact
Contact Point:
Klaus Stüwe - klaus.stuewe@ages.at