Work Package 7 – Quality Management Systems

Work Package 7 was created to increase existing knowledge on quality management systems for pharmacovigilance staff at National Competent Authorities through its provision of a training program. WP7 delivered a toolkit which can be used for the further development of quality management systems (QMS) in pharmacovigilance.

Objectives:

1. To increase existing knowledge on quality management system of pharmacovigilance staff at National Competent Authorities through development of a training program and a toolkit which can be used for the further development of QMS.

Topics

Within Work Package 7, there were three individual topics which were working on:

1. Enabling Member States to understand, and develop their quality management systems for pharmacovigilance – lead: OGYEI
2. Resource management – lead: MHRA
3. Interaction with Pharmacovigilance Inspectors – lead: MHRA

Outputs and results

European Member States were asked to complete three Work Package 7 surveys in order to identify the current methods and preferences in place for their pharmacovigilance Quality Management Systems (QMS). The Topic 1 survey asked Member States a series of questions in order to explore their National Quality Systems, while Topic 2 addressed how Member States approach Resource Management. Topic 3 addressed the interactions with Pharmacovigilance Inspectors. The responses were collated and analysed, and are presented in the three reports below. The results from these reports were used to construct the training deliverables for WP7.

SCOPE WP7 Topic 1 Survey Report: Understanding National Quality Systems

SCOPE WP7 Topic 2 Survey Report: Resource Management

SCOPE WP7 Topic 3 Survey Report: Interaction with Pharmacovigilance Inspectors

WP7 developed learning materials focusing on quality standards for PV assessment, quality planning, feedback to stakeholders, compliance performance management, resource management, exchange of information between PV assessors and inspectors, and data and record management. 

Click here access WP7 materials.

Quality Management Systems training

The training on quality management systems was organised by the National Institute of Pharmacy and Nutrition (OGYÉI) on 4^th October in Budapest. Topics covered included: quality planning, compliance, standards for PV assessment reports, feedback to stakeholders, and workload planning. In addition WP7 presented lectures on QMS at WP4 and WP8 training workshops.

Partners involved

Lead: OGYÉI (Hungary)

AIFA (Italy)

AEMPS (Spain)

BDA (Bulgaria)

INFARMED (Portugal)

MHRA (UK)