The quality managers of National Competent Authorities (NCA) with regard to public and animal health met in Bratislava as part of the programme under the Slovak Presidency of the EU.
The State Institute for Drug Control (SIDC) hosted the members of Working Group of Quality Managers (WGQM) in the Austria Trend Hotel premises located in the centre of Bratislava from 9.-11. November 2016.
After informal welcome buffet in the evening of arrival day, the delegates continued next two days with busy agenda. Formal part was opened by the Chair of WGQM Caitriona Fisher and by the Executive Director of the SIDC, Zuzana Baťová, who warmly welcomed more than 30 participants and wished them productive working atmosphere and enjoyable stay in Slovakia during following days.
The agenda of WGQM meetings is usually derived from the WGQM work plan that is regularly updated ensuring so continuity of all individual meetings held during consequent Presidencies in different EU countries.
As part of this work plan, the items regarding Pharmacovigilance legislation, Conflicts of interest, Business continuity management and Risk based regulation were reviewed and their further maintenance was discussed.
The group was updated on progress of the NCAs evaluations by both, external assessors within the framework of benchmarking “BEMA IV” coordinated by Croatia and external auditors within the framework of Joint Audit Programme related to Good Manufacturing Practice Inspectorate sponsored by European Medicine Agency (EMA). Gathered experiences were presented by representatives from France, Belgium and Austria.
Items related to quality management standards covered by ISO 9001 as well as pros´ and cons´ regarding recertification after issuing its revised version with increased importance given to risk and knowledge retaining were explored by the delegates from the United Kingdom and Austria.
Employees´ trainings dedicated to acquisition of suitable knowledge regarding quality management system and quality standards were presented by the Irish and Slovak quality mangers and also discussed by all in the workshop. Preparation of guide that would address training requirements covering basic, competent and advanced levels with regard to quality management system was considered.
Information about documents and records control which represent an inherent part of quality management system was exchanged. Quality managers from Germany and Slovakia reported about their efforts undertaken to manage lean documentation system that would be transparent and effective in managing documents used to direct and record NCAs activities.
During the plenary session, current development of work plan regarding Risk management, Business planning and performance measurement and Electronic Systems used to document corrective and preventive actions were discussed and items were updated accordingly.
This was a first WGQM meeting held in Slovakia thanks to the Slovak Presidency of the EU. The meeting was closed by the invitation of quality managers to the next WGQM meeting taking place in Malta in June 2017.
About WGQM :
In support of the efforts of the European Medicines Regulatory Network (EMRN) with regard to public and animal health, the Heads of Medicines Agencies (HMA) Working Group of Quality Managers (WGQM) provides guidance relating to quality management and best practice benchmarking.
The Working Group:
• acts as a forum for discussion to agree on common principles to be applied throughout the EMRN,
• operates to improve the exchange of quality management expertise and to contribute towards the development of best practices for quality management
• reports to HMA on all cases where consistent practices are considered to be in the interest of the Community.