Working Group of Quality Managers (WGQM)

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| pdf
  Document adopted in September 2020 - version 4

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 Point:

Klaus Stüwe - klaus.stuewenoSpam@noSpamagesnoSpam.at 

• Guide to Business Continuity Management| pdf 
  Document adopted in November 2020 - version 2
  (Please download PDF file instead of opening it in the browser to see embedded annexes)
• HMA Guide to Managing Declarations of Interest| pdf
  Document adopted in November 2023 - version 3
• Guide to Risk-Based Regulatory Approaches | pdf
  Document adopted in November 2023 - version 3

The Working Group on Quality Management (WGQM) functions as a collaborative platform for Quality Managers within EU/EEA medicines agencies. Its primary focus is the exchange and refinement of Quality Management standards, including external assessments conducted by BEMA, JAP, Union Controls  or national certification bodies. Emphasis is placed on Process Management, Risk Management (encompassing Business Continuity and Information Security Management), and the nuances of internal audits.

WGQM has developed a comprehensive set of guidelines, a portion of which is available in the Key Documents  Section. Notably, the group has developed an Internal Auditor's Curriculum, delivered through a series of webinars hosted on the EU Network Trainings Center. Complementary to this, WGQM provides guidance and checklists tailored for internal audits, including audit checklists specifically designed for the implementation of Good Pharmacovigilance Practice (GVP) modules in National Competent Authorities (NCAs).

WGQM serves as a platform for the exchange of opportunities for improvement and strengths identified by BEMA or other sources. WGQM functions as a  hub for collaborative knowledge exchange, aiming to harmonise practices and to elevate performance standards in the European Medicines Regulatory Network.

WGQM Work Plan 2021-2025

Work Stream 1: Quality management standards, including external assessment

1.1    Ensure that all NCAs have a fully functional and agile QMS in place

1.2    Support the BEMA program by updating NCAs on new developments and support preparation and follow-up of BEMA assessments

1.3    Update quality managers regarding developments relevant for NCAs’ quality systems

1.4    Maintain an overview of the certification status of NCAs

Work Stream 2: Process Management

2.1    Foster awareness of NCAs’ external context and stakeholder expectations

2.2    Help NCAs to manage changes, including new legislative requirements

2.3   Support a common approach to measure performance & effectiveness

2.4   Encourage effective approaches in risk-based regulation

2.5    Ensure structured development of competencies

2.6   Optimisation of processes and use of resources through lean and agile methodologies

Work Stream 3: Risk management

3.1    Support NCAs to embed risk management principles across the organisation

3.2    Support NCAs in developing robust business continuity plans, based on coordinated prioritisation criteria

3.3   Build competency on information security management systems

Work Stream 4 Internal Audits

4.1    Support quality managers to improve their NCAs' system for risk-based internal audits

4.2    Support a common approach in internal auditing to fulfil relevant requirements

4.3   Build competency for internal information security audits

Work Stream 5 Best practices

5.1    Share best practices (identified through BEMA or spontaneous contributions) among the network